What You Need to Know

What Are Standards of Identity?

A “standard of identity” is an agreed upon legal definition for what a food actually is. Standards of identity were introduced as a means of consumer protection. Although “common name” is the most applicable facet of Standards of Identity, there are actually three components to consider:

1. Common Name (Identity): The standardization and definition of common food names ensures that consumers know what a food product actually is. Typically, the common name is required to be written on the label of a food container.

   
   Example: A food marketed as “canned tuna” must legally be tuna and not some other fish
   
   
   
   

2. Standard of Quality: The food meets certain quality standards described in the regulations for that standardized food. (This doesn’t apply to most foods).
   
   Example: A food marketed as canned tuna cannot contain ingredients or additives that the consumer would not typically associate with canned tuna
   
   
   
   

3. Standard of Fill of Container: The packaging contains a minimum fill defined for that standardized food. This doesn’t apply to most foods)

Example: If canned tuna is advertised as 8oz of canned tuna in broth, then you are getting 8oz of tuna and not 7oz of broth and 1oz tuna.

Does My Food Product Have a Standard of Identity?

The best way to find out what the regulatory requirements are for your particular food product is to understand exactly which one of the following groups it falls into:

1. Foods for which there categorically is no definition or standard of identity

According to the FD&C act, no standard of identity or definition may be established for:

• Fruits (fresh and dried)

• Vegetables (fresh and dried)

• Avocados,

• Cantaloupes

• Citrus fruits

• Melons

This means there’s no specific definition for what is an apple and it means there’s no regulation that the word “apple” must appear on an apple that is being sold. If you produce a product that falls into this category, then you don’t need to be particularly concerned about misbranding your product due to standards of identity/definitions.

2. Non-standardized foods subject to specific requirements

These foods don’t have standards of identity per se, but they are subject to some requirements. You can quickly review this small list of foods in 21 CFR Part 102.

If the food you produce falls into this category, then it’s important to understand these requirements, but otherwise your product is not a standardized food.

3. Standardized Foods (Foods which have a standard of identity)

These are foods that the FDA has decided to define because there is a public expectation of what that food is . Anyone who makes a” standardized” food must make sure it satisfies the standards outlined for that food. These requirements range from mandated ingredients to packaging standards, to banned ingredients.

The categories for all standardized foods are listed in the sidebar to the right.You can also access these categories in CFR Parts 131-170

4. Non-standardized foods

These are foods that simply are not addressed in any of the sections referenced above. Since they are non-standard then they don’t have specific requirements for calling your food that name. Non-standardized foods must be labeled using the common or usual name for that food.

Many innovative products fall into this category. However, if you wish to market your product as something for which there is a standard of identity, then you must adhere to those standards or market your product differently.

For example, if you make a fermented chia-seed snack food that you wish to market as Chia Yogurt, then you must comply with the standards of identity definition for “yogurt” —since that’s how you are marketing the product. If your product is categorically unfit to meet the definitions of yogurt, then you may consider marketing it using descriptive terms (i.e. “fermented, plant-based snack food).

Identity Labeling Requirements

Packaged foods must be labeled with the product’s identity (common name). The requirements are as follows:

• The statement of identity must be presented in bold type on the Principal Display Panel

• If the food is marketed in multiple forms (i.e. whole, sliced, diced) then the form of the product is deemed to be part of the statement of identity

Formatting:

• The text must be bolded and in a size “reasonably related to the most prominent printed matter on the panel”

• The wording must be parallel to the base of the packaging so it reads normally when displayed (not sideways or upside down).

Less Common Requirements:

• Dietary supplements must be identified in the identity statement in one of three ways:

  • Using the term “dietary supplement”

  • Using the convention “[nutrient name] supplement” (i.e. “Iron supplement)

  • Using a descriptive term indicating the ingredients in the product (i.e. herbal supplement with vitamins)

• Substitution or imitation foods must be identified as such in the identity statement (i.e. imitation crab) A substitute food resembles another food and is meant to substitute it. An imitation food is the same except that it is nutritionally inferior to the food it imitates.

Source: 21CFR 101.3

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FAQ

What if My Product Doesn’t Have A common Name Because It’s an Innovative PRoduct?

In that case, you may use a descriptive term in the identity statement

What if My Product falls under a Standard of Identity but fails to meet the regulated standard?

A food producer may apply for a Temporary Marketing Permit (TMP) which allows them to sell their product for 15 months even though it may not confirm to some art of the applicable “standard of identity”.

For example, according to the FDA, Canned Pacific Salmon can only contain pacific salmon, water, and salmon oil.

In 1988, Bumblebee applied for a TMP which would allow them to add a tasteless, odorless preservative called sodium tripolyphosphate to the product. Normally, Bumblebee would not be allowed to sell the product as Canned Pacific Salmon, since the product would not fit the standard of identity.

However, the TMP gave them the permission to temporarily circumvent the standard of identity and sell their product (it’s worth nothing that sodium tripolyphosphate was an allowable food additive at that point.)

Food Categories with Regulated Definitions:

• BAKERY PRODUCTS

• BEVERAGES

• CACAO PRODUCTS

• CANNED FRUIT JUICES

• CANNED FRUITS

• CANNED VEGETABLES

• CEREAL FLOURS AND RELATED PRODUCTS

• CHEESES AND RELATED CHEESE PRODUCTS

• EGGS AND EGG PRODUCTS

• FISH AND SHELLFISH

• FOOD ADDITIVES

• FOOD DRESSINGS AND FLAVORINGS

• FROZEN DESSERTS

• FROZEN VEGETABLES

• FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

• FRUIT PIES

• MACARONI AND NOODLE PRODUCTS

• MARGARINE

• MILK AND CREAM

• SWEETENERS AND TABLE SIRUPS

• TREE NUT AND PEANUT PRODUCTS

• VEGETABLE JUICES

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To learn more about Foreign Supplier Verification Programs overall, see our introduction article

How Do I Develop a Foreign Supplier Verification Program?

Contents

How Do I Develop a FSVP?

1. Determine Your Qualified Individual
2. Decide How Your Program Works
3. Conduct Your Verification Activities
4. Approve Your Suppliers and Maintain Your Program

Keeping Records of Your FSVP
Taking Corrective Actions
Re-evaluating Suppliers

If you import products for consumption into the US, you likely are required to develop a foreign supplier verification program (FSVP).

Below is a step by step guide to developing and implementing an FSVP.

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1. Determine your Qualified Individual

First, The FSVP must be prepared by a "qualified individual" who has the education, training or experience necessary to perform the activity. If this person is a 3rd party or consultant, that's fine. However, note that supplier verification is an ongoing process and it must always be completed by a qualified individual. For most companies, the easiest solution is to have someone on staff undergo a 2 day training course on developing a Foreign Supplier Verification Program.

Source 21 CFR 1.503

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2. Decide How Your Program Works

Before you begin approving suppliers, you must establish the procedures you will use to approve suppliers. The goal is to provide assurance that hazards in the food you import are being prevented.

You can rely on a 3rd party to conduct your supplier verification if you review and assess the documentation yourself and document your review and assessment of the materials.

Examples of appropriate verification activities:

• Onsite audit by a qualified individual

• Sampling & testing

• Review of foreign suppliers food safety records

• Other appropriate supplier verification activities

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3. Conduct Your Verification Activities

This step is the bulk of the process: collecting information from your suppliers, reviewing it, and documenting your review process.

You may rely on a 3rd party to conduct supplier verification activities (i.e. a 3rd party audit) if you assess their documentation with appropriate frequency. You must document your review and assessment of the activities and document that the activities were performed by a qualified individual.

The following are common verification methods for approving suppliers:

Hazard Analysis

You are required to review a hazard analysis for each type of food you import. Hopefully, each of your foreign suppliers has completed one and can provide this to you. If not, then you must conduct a hazard analysis to determine whether there are any hazards requiring a control. This hazard analysis must be written and contain an evaluation of environmental hazards.

Some key points about the hazard analysis:

• You must either conduct a hazard analysis for each type of food you import OR use a supplier hazard analysis.

• If you are importing Raw Agricultural Commodities (RACs) then no biological hazards need be considered in the Hazard analysis.

• If you are reviewing a hazard analysis supplied by the supplier or a 3rd party, then you must document your review of the hazard analysis and confirm that it was conducted by a qualified individual.

• If no hazards are identified which require a preventive control, then no verification is required for those products. Still you must have a hazard analysis on file to show that this has been determined. This provision does not apply to produce.

Subpart L  - FSVP for Food Importers

Onsite Audit

Certain importers may wish to independently conduct onsite audits of the foreign supplier. Or, they may simply review the audit results conducted by a reputable 3rd party auditor.

An audit is required as part of the supplier verification process when there is "reasonable probability that exposure to the hazard will result in serious adverse health consequences or death" you must conduct or obtain documentation of an onsite audit at least annually. (1.506 (d) (ii) (2)

In this case, an audit may be replaced by written inspection results by the FDA, USDA, or a food safety authority of a country whose food safety system is equivalent to that of the US.

Sampling & Testing of Food

If you choose to use product testing and sampling as part of your verification, you must retain documentation of the following:

• The number and type of samples tested

• identification of the food tested (lot numbers)

• tests conducted and the methods of the testing

• Any corrective action taken into detection of hazards

• Information identifying the lab

• Documentation that the tests were performed by a qualified individual.
  

Review of Foreign Supplier's Food Safety Records

The most common method of supplier verification is the review of a foreign supplier's food safety records.

If you choose to use your foreign supplier's food safety records as part of your verification, you must retain the following information:

• The records reviewed

• Dates of review

• General nature of the records reviewed

• Conclusions of review

• Any corrective actions taken in response to significant deficiencies identified.

• Documentation that the review was conducted by a qualified individual.

You may not allow on the foreign supplier to conduct supplier verification activities for their own business.

Final Considerations:

Hazards Not Controlled by the Foreign Supplier

Does a 3rd party control one of the hazards on behalf of your supplier (i.e. your overseas milk supplier has their pasteurization completed offsite by another company.) If so, you must collect this verification data from the 3rd party or have your supplier send it to you.

Supplier Performance & History

It is perfectly acceptable to take into consideration your supplier's history, procedures, practices, storage, transportation, etc as part of your verification activities.

Document Your Verification Activities

Remember, it's not enough to simply collect these documents from your foreign suppliers -- you have to assess them and document that assessment.

For example, let's say I'm an importer of Ned's Italian Tomato Sauce and they send me their most recent audit result. Beyond having that audit result on file, I need to record that I reviewed that audit, that it showed me they controlling the hazards in their process, and that my review occurred on such-and-such date.

The Whole Picture

For fear of stating the obvious, you must approve your foreign suppliers on the basis of your evaluation. In other words, you must consider all the information you gather in your approval process and cannot discount any piece of information simply because it is contrary to the result that you're looking for.

This doesn't mean that one failed audit in your supplier's history means you cannot approve them. However, you must acknowledge this information if it is revealed in your verification activities or outside of them.

Source 21 CFR -- 1.504

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4. Approve your Suppliers and Maintain the Program

Once you have completed your verification activities, you may add the relevant supplier's to your approved supplier list and begin sourcing product from them. At that point, the program should require only occasional ongoing maintenance

Keeping Records of Your Foreign Supplier Verification Program (FSVP)

Your records should comply with the following provisions:

• They must be originals, photocopies or digital records

• You must keep them for 2 years unless otherwise specified

• They must be available for review by the FDA

• You do not need to have a specific copy of each record for the FDA (e.g. you can have one copy of a record to satisfy both a state requirement and a federal requirement)

Source 21 CFR §1.510

There are several exemptions to Foreign Supplier Verification Requirements. This section applies to:

Taking Corrective Actions

You must take corrective actions if you determine that the food you are receiving is not meeting the requirements of the FDA regulations. Simply put, if the food you receive could cause harm to a consumer or is unsafe, then you must take some type of corrective action. This determination could be based on customer complaints or verification activities that you conduct (i.e. records review or viewing an inspection result.)

The appropriate corrective action to take could include discontinuing your use of that supplier until the hazards have been addressed.

If this determination occurs outside of the scope of your supplier verification activities, then it may reveal that your verification activities are not comprehensive. Simply put -- you didn't catch the mistake in your normal supplier verification practices therefore something is inherently wrong with your process. In this case you are obligated to update your plan so that you are able to adequately verify your suppliers.

Source 21 CFR §1.508

Re-evaluating Suppliers

You must re-evaluate your foreign suppliers (and document it),

• Every 3 years, at minimum

• When you learn anything new or when anything has changed that would warrant a re-evaluation.

You may use a 3rd party foreign supplier review as your re-evaluation, insofar as you document your assessment of that evaluation. The evaluation must be performed by a qualified individual.

Source 21 CFR -- 1.504

This article applies to you if…

∆ You are a food importer

∆ The products you import are regulated by the FDA

∆ You do not qualify for a small-food-importer exemption (<$10mm/yr imported)

∆ You need to build a foreign supplier verification plan

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ConsultinG Services

It’s not always clear where  the FDA has jurisdiction when it comes to food businesses. This table provides an overview of FDA Jurisdiction. Specific examples are provided below.

Regulated By the FDA	Not Regulated By the FDA
Foods that enter interstate commerce	Food Service Establishments
Most packaged foods	Restaurants
Most foods solid online	Restaurant Chain
Human and animal food	Food Truck
Imported Foods	Caterer
Farms (if they grow and process food)	Grocery Stores
	Food Bank
	Cafeterias / Institutions
	Markets
	Home-Food Processor
	Alcoholic Beverages
	Butcher Shop
	Slaughterhouses (USDA)
	Farms (if they only grow food)

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*Note: Domestic food processors of any kind must still register as a Food Facility even if their products do not enter interstate commerce. This is free and purely for record keeping purposes (it will not subject a business to FDA inspections or oversight)

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Examples of FDA Jurisdiction Businesses

FDA Jurisdiction	Examples
Food products that enter interstate commerce (i.e. businesses whose foods leave the state)	Most foods sold online
	Most non-meat products that are made and sold in a package
	A central kitchen that prepares and distributes foods to locations in multiple states
	A transporter that distributes food nationwide
	Any business that processes, packs, transports, distributes, receives, or holds food which crosses state lines.
Imported Foods	Food distributor that imports foods and sells it
	Food importer that warehouses food

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Businesses Not Under FDA Jurisdiction

Not FDA Jurisdiction	Example	Who typically regulates
Restaurant (Individual)	Fast Food Restaurant	Local/State health dept.
Restaurant (Chain)	Chain of frozen yogurt restaurants	Each would be regulated individually by its respective local or state health department
Restaurant (Delivery only)	Meals are ordered via app/web and delivered hot to the consumer	Local/State health dept.*
Food Truck	Korean food truck	Local/State health dept. *
Caterer	Facility where a caterer prepares food for immediate service	Local/State health dept.*
Grocery Store	Grocery store that also serves some hot food or includes a deli	Local/State health dept.
Food Bank	Food bank that accepts food donations and distributes that food locally	Local/State health dept.
Cafeteria / Institution	Hospital cafeteria, School lunch cafeteria	Local/State health dept.
Farmers Market	Weekly market that offers various prepared foods and ingredients for sale	Local / State Health Dept
Seafood Market	Retail market that supplies seafood products to consumers	Local / State Health Dept
Alcoholic Beverage Producer, Importer, Distributor, Wholesaler	Winery, Brewery, Distillery	State Health Dept / TTB (Note that alcoholic beverages <7% ABC are subjected to FDA labeling standards)
Butcher Shop	Retail market that butchers and retails meat for consumers	Local/State Health Dept. OR USDA. (This depends on what level of processing is being done to the meat before it is sold)
Home Food Processor	Business conducted from the home that involves making food	Local / State – Note that many cities and states prohibit or specifically regulate home processing
Meat Product Processor	Frozen meat pies, Bone broth, High-quality cuts of steak delivered via mail	USDA
Poultry Product Processor	Frozen buffalo wings, Roast Chickens	USDA
Processed Egg Products	Frozen omelets, Egg whites	USDA

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*If you serve or prepare food in multiple areas you may have to license with the local health department for each of those jurisdictions. If the food is crossing state lines, then FDA regulation would apply.

Still Unsure Whether Your Business is Regulated by the FDA?

Ask a question in the comments and I’ll answer it

Try using this dichotomous key

What’s Next?

Understand about Registering a Food Facility with the FDA

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For step-by-step instructions, see Guide to Developing an FSVP

What You Need to Know about FSVP

Contents

What You Need to Know
Applicability and Exemptions
Very Small Importer Exemption
Foreign Suppliers Requiring No Verification
Foods Subject To Special Foreign Supplier Verification Regulations
FAQ

• Nearly all food imported into the US must be produced in alignment FDA Regulations

• Foreign Supplier Verification Program (FSVP) is a major component of FSMA which requires US businesses to only import food products from suppliers they have vetted and approved.

• Most businesses which import food products for consumption inside the US must verify that the food is produced in alignment with FDA regulations. This is done through the implementation of a Foreign Supplier Verification Program (FSVP). When a certain type of food (i.e. seafood) is subject to specific regulation, a foreign supplier must also comply with those specific standards.

• The verification process may include, among other methods: an assessment of the supplier's food safety records, a review of an audit report, or a site visit.

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Applicability and Exemptions

Generally, foreign supplier verification is required for most importers, for most imported foods, and for most foreign suppliers. To better understand what types of businesses and products may not be regulated under Subpart L (Foreign Supplier Verification Program), see the exemptions below:

Very Small Importer Exemption

A "Very Small Importer" is a company that imports $<1mm year in product value for imported human food (or <$2.5mm year in value for imported animal food)

Modified requirements for "Very Small Importers"

• A very small importer must document that they meet the qualification for this exemption (i.e. be able to prove they are doing less than $1 million in imports)

• Receive a written assurance from each foreign suppliers, prior to importing any food. The written assurance must be obtained every 2 years and include the following

1. A brief description of the preventive controls being applied to control hazards in the food. This must be provided for each food that is imported.

2. A statement that the foreign supplier is compliant with FDA regulations or (when equivalent) the relevant laws of their own country

• You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

• You must keep signed and dated records of these activities for > 2 years.

Foreign Suppliers Requiring No Verification

An importer is not required to conduct verification activities for certain foreign suppliers, including

• Qualified Facilities, or

• farms that grow produce and are not covered under part 112, or

• A shell egg producer that has fewer than 3,000 laying hens.

• Suppliers operating in countries with an officially recognized or equivalent food safety system

If you are importing products from a foreign supplier that is exempt, the modified requirements are as follows:

• You must obtain a written assurance of their exemption type (i.e. farm or qualified facility or small shell egg producer)

• You must initially evaluate your foreign supplier's performance history as it relates to compliance with FDA regulations. You must re-evaluate this if you become aware of any relevant changes or information or ever 3 years at minimum.

• You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

• You must keep signed and dated records of all verification activities for > 2 years.

• You must approve your foreign suppliers based on the activities described above.

• You must establish written procedures to ensure that you are using only approved foreign suppliers. You may import from unapproved suppliers on a temporary basis, if you have other, adequate verification prior to import.

Source 21 CFR §1.512

Countries with Officially Recognized or Equivalent Food Safety Systems

If you are importing from a country with a recognized equivalent food system, you may be free from the following the majority of FSVP requirements (§1.504-§1.508). As of 2018, the only countries who have achieved this are: Australia, Canada, and New Zealand.

However, your program still must be developed by a qualified individual, your company must be identified upon food import, and you must maintain your FSVP records in compliance with §1.510.

Source 21 CFR §1.513   

Foods Subject to Special Foreign Supplier Verification Regulations:

Certain foods are exempt from Subpart L (the requirements for Foreign Supplier Verification Programs outlined in this article) and are subject to different requirements.

Imported Seafood Products (aka Fish / Fishery Products)

Since seafood products are subject to specific FDA regulations found in Part 123, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 123. You can read about the specific requirements for verifying a foreign seafood supplier here

Imported Juice Products

Juice products are subject to specific FDA regulations found in Part 120, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 120 (specifically, that they have and follow a HACCP plan).

Meat Products

The Foreign Supplier Verification Program does not apply to meat products that, at the time of import, are under USDA jurisdiction.

Food that cannot be consumed without the hazards being controlled

You aren’t required to conduct an evaluation or foreign supplier verification when:

• The food can’t be consumed without controlling for the hazard

• You rely on the customer (who must be subject to 117C) to control the hazards. In this case you must disclose this to the customer and obtain annual assurance that they are controlling for the hazard

• You rely on a subsequent entity in the supply chain (further downstream from you and the customer) to control for the hazard.

Source 21 CFR §1.507

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FSVP FAQ

How must the importer be identified at entry?

You must identify your firm as the importer and include your FDA identification (DUNS) number and email address when filing for entry. The foreign owner or consignee of the food oversees must designate a US representative as the importer as the food.

Source 21 CFR §1.509

What are some consequences of failing to comply with the requirements of this subpart?

• The food may be inadmissible for import.

• The importer may be found in violation of federal law.

Source 21 CFR §1.514

What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?

Source 21 CFR Section 1.511

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Consulting Services

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What You Need to Know

Correction

A correction means taking action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety.

Examples of corrections include:

• Re-cleaning the production line if it appears dirty after the first clean.

• An employee is asked to leave the production area and put on the proper attire before re-entering the production area.

• The temperature of a walk-in refrigerator is adjusted because it is a time of high traffic and the temperature is approaching the critical limit.

Corrections occur in the moment and don't require any documentation

Corrective Action

A corrective action is a procedure that must be taken if a corrective action is not properly implemented. This must be documented and the record should describe:

• What occurred

• How the problem was corrected

• How it will be avoided in the future

• What was done with the product in question

Examples where corrective action is required include:

• A sample of canned salsa is tested and the pH exceeds the requirement of <4.3.

• A refrigerator is found to have exceeded the temperature requirement of ≤41ºF for several hours.

• The producer of bottled juice realizes that during the last production run, numerous bottles were not properly sealed by the capping machine, possibly due to defective packaging.

For more about corrective actions, see our full guide

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Correction or Corrective Action?

The following examples illustrate how an operator may choose between a correction and a corrective action

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Scenario	Type of Action Required	Why	Recommended Action
Cookies on a conveyer oven are finished in 8 minutes instead of the required 10 minute cook time	Corrective Action	The cook step is (presumably) a preventive control used to kill bacteria present in raw cookie dough. Because the product failed to achieve the 10 minute cook time, then the preventive control has failed and a corrective action is required.	1. Adjust the belt temperature to reseet to 10 minute cook time. 2. Test to confirm the belt speed has increased the cook time to 10 minutes. 3. Re-cook the cookies for an additional 2 minutes (or discard) 4. Record this on a corrective action form.
Cookies on a conveyer oven are completed in 12 minutes instead of the required 10 minute cook time	Correction	Since the product was overcooked, it still achieved the preventive control that requires a >10 minute cook time.	Adjust the belt speed to reduce the cook time to 10 minutes. Consider testing the overcooked product for quality
Sheet pans are observed to be unclean immediately after being run through the dishwasher	Correction	This is a minor problem that poses no risk to the safety of the food if it is corrected.	Re-run the dishes through the dishwasher and confirm they are clean.
The dispenser for dishwasher sanitizer chemical is discovered to be empty after a day of production	Corrective Action	It is possible that many utensils and dishes were used in production without having been sanitized. This directly impacts food safety of product that was produced and so corrective action should be taken.	1. Refill the sanitizer chemical in the dish machine and confirm it is being applied during the cycle. 2. Assess why the sanitizer ran out and whether chemical levels should be checked more frequently to avoid this problem recurring. 3. Evaluate the food that contacted the un-sanitized utensils/dishes and determine whether it should be discarded, re-worked or served. If the food cannot be proven to be safe then it should be discarded.

Resources

Corrective Action Template

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This is an overview of record keeping requirements. For a more in-depth review, see our Guide to 117 Subpart F: Record Keeping

What You Need To Know

Part 117 Subpart F contains the requirements for record keeping

• Keep all of your records related to your food safety lan.

• Records can be electronic or paper.

• You must store records onsite for at least 2 years

• All records must be made available upon request

Record Keeping Requirements

How Records Must Be Kept

• Records must be kept as originals, true copies (i.e. scans, photocopies) or electronic records.

• They must contain the actual values and observations, not summaries.

• They must be accurate, unchangeable (i.e. pen) and legible

• They must have been created in real-time with the activity being documented.

Required Information on All Records

The following information is required on all records you keep:

1. information about the plant identity

2. The date (and time, if necessary)

3. Signature or initials of the observer

4. Product name and lot code, if applicable

How long do I need to keep them for?

All records must be retained onsite for 2 years. Additionally, you must be able to retrieve records within 24 hours if an authorized request is made.

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Looking for More?

Check out our comprehensive guide to Part 117 Subpart F, Record Keeping or the FDA Reader Complete Guide to FSMA

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This Article is For You if…

∆ You take any records as part of your food safety plan

∆ You are developing a food safety plan or HACCP plan.

∆ You are any type of FDA regulated food business

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All of our food safety plan templates are aligned with this section.

Resources

FDA Regulation On Record Keeping

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What You Need To Know:

• Validation answers the question “How do you know it works?”

• You must validate that the preventive controls that you implement actually work.

• Validation activities includes using scientific and technical evidence (or conducting your own studies)

Example of Validation: Collecting scientific research, and conducting tests to prove that the cooking temperature in your recipe is effective in killing the harmful bacteria in the product.

Hint: you can find information to validate many food processing practices on the FDA website.

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What is Validation?

Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.

21 CFR 117(c)(1)(i)

When is Validation Required?

You are required to validate every preventive control you are implementing. This means that if you use cooking as a means to kill bacteria, then you need to show that the time and temperature are a valid method for killing that bacteria type. This can often be achieved by referencing FDA guidance materials.

You are not required to validate the following types of preventive controls:

• Sanitation Preventive Controls

• Food Allergen Controls

• Recall Plan

Who Conducts Validation?

All validation activities must be performed by a preventive controls qualified individual.

When do I need to validate my preventive controls?

You must validate your preventive controls:

• Within 90 days of beginning production or there must be written justification for why if  >90 days after production begins.

• Whenever a change is made that could impact how a hazard is controlled.

• Whenever the food safety plan is reanalyzed.

What Part of My Food Safety Plan Require Validation?

Some parts of your food safety plan do not need to be validated. Sanitation activities, for example, do not need to be validated because most people use a small set of scientifically proven processes (i.e. soap and water, common chemical sanitizers). As a result, there is no need to require each business to prove their sanitation practices actually work.

The following activities do not require validation

• Food allergen controls

• Sanitation controls

• Recall plan

• Supply chain program

• Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control

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Resources

Verification vs. Validation

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FDA Regulation on Validation

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If you are unsure whether corrective action is required, see Verification vs. Validation

What You Need To Know

• Verification means confirming that other parts of the food safety plan have been undertaken as specified.

• Verification can take the form of a supervisor regularly reviewing records and verifying them with a signature.

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What is Verification?

Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.

21 CFR 117(c)(1)(i)

Examples of Verification

Common examples of verification include:

• Reviewing cooking records to confirm the required temperature and cook time was reached

• Reviewing refrigeration records to confirm food was held sufficiently cold

• Observation that employees are following good food-handling practices

• Calibrating thermometers – this verifies that they are reading properly

• Sampling your own product for pathogens to verify that your process was faithfully performed

• Environmental monitoring – testing your production space for pathogens living on surfaces, in drains, etc.

• Supplier Verification – reviewing a supplier’s records to confirm they are faithful to their food safety practices and claims.

When is Verification Required?

All records which monitor a preventive control must be verified within 7 days of their creation.

All corrective action records must be reviewed within 7 days of their creation.

Other verification records, such as instrument calibration, product testing, and environmental monitoring, must be verified “within a reasonable amount of time” as determined by the producer.

Who Conducts Verification?

All verification activities must be performed by a preventive controls qualified individual (PCQI).

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What You Need to Do:

• Verify that your preventive controls are being implemented and monitored. You can do this by checking that monitoring records were completed.

• Verify that corrective actions are taken when necessary and that the right decisions are being made in relation to any process deviations.

• You must keep your verification records on file (digital is fine)

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or have identified a hazard that requires a preventive control

∆ You take any records as part of your food safety plan

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Resources

Verification Log Template

FDA Regulation on Verification

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If you are unsure whether corrective action is required, see Corrective Action vs. Correction

What You Need To Know:

• Corrective Action is a response that must be taken if a preventive control is not properly implemented.

• Corrective Actions must be written and are often completed using a standard form (see our free Corrective Action template)

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What You Need to Do:

1. Write Corrective Actions Procedures

You must establish and implement written corrective action procedures. These procedures must describe the steps to be taken to ensure that:

• Appropriate action is taken to correct a problem associated with a preventive control.

• Appropriate action is taken to reduce the likelihood that the problem will recur.

• All affected food is evaluated for safety

• All affected food is prevented from entering commerce.

2. Take Corrective Action When it is Required

When to Take Corrective Action:

You must take a corrective action if

• A preventive control fails and a corrective action hasn't been established.

• A preventive control is found to be ineffective

• Verification records are found to be incomplete or improper decisions were made about corrective action

3. Keep Records of Your Corrective Actions

All corrective actions taken in this section must be documented. We recommend using a pre-written form so that it’s easy to complete and no details are missing. Check out our corrective action template here

Corrective actions must also be verified (See Verification or §117.155)

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This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control or identified a hazard that requires a preventive control

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Resources

FDA Regulation on Corrective Actions

Corrective Action Template

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These requirements are a part of our comprehensive Food Safety Plan Guide

What You Need To Know:

• Monitoring means observing some activity in your production— such as checking the temperature of your walk-in refrigerator

• Monitoring is required for all preventive controls to ensure they are implemented properly.

• You must have written procedures for how and how often you will monitor preventive controls.

• You must monitor preventive controls enough to ensure they are being performed.

Record Keeping Requirements

1. You must document your monitoring actions, store them, and also verify them (see verification)

2. Exception records are acceptable type of monitoring record (this means records are only taken when a deviation occurs.) For example, a refrigeration log may shows records only when the temperature is outside the acceptable range.

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Resources

FDA Regulation on Monitoring Preventive Controls

This Article is For You if…

∆ You are developing a food safety plan or HACCP plan.

∆ You have implemented a preventive control

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These requirements are a part of our comprehensive Food Safety Plan Guide

What You Need To Know:

• A preventive control is a strategy implemented to eliminate a hazard in a food manufacturing environment

• You must identify and implement preventive controls when you identify a hazard that is reasonably likely to cause injury to a customer if left unaddressed.

• Preventive controls include Critical Control Points and other types of controls.

• Preventive controls must be written

Types of Preventive Controls

Process Controls:

These are procedures and processes that are used to control parameters of processing (i.e. acidifying, refrigerating, cooking.) They must be written in a way that is specific to your process and they must include:

• parameters associated with controlling the hazard (i.e. if you are using cooking as a process control, then you must include the required cook temperature and cook time)

• The maximum or minimum values required to control the hazard.

Food Allergen Controls

These include processes to control food allergens. These are implemented to:

• Protect food from allergen cross contact

• Label food properly with allergens to ensure it isn't misbranded

Sanitation Controls:

These are practices to ensure the facility is kept clean and to minimize biological hazards. They relate to:

• Cleanliness of food-contact surfaces (equipment, utensils, tables)

• Prevention of contamination of food from dirty sources (i.e. dirty people, dirty food, dirty packaging, dirty raw ingredients)

Supply Chain Controls:

Supply Chain Controls are described fully in Part G

Other Controls

You may have other types of controls (i.e. hygiene training and current good manufacturing practices)

What To Do If You Implement a Preventive Control

If you implement one or more preventive controls then you must conduct the following activities for each one:

1. Monitoring activities

2. Corrective actions

3. Verification activities

Circumstances Where Preventive Controls Are Not Required

You aren't required to implement preventive controls if any of the following apply:

1. The food cannot be consumed without application of an appropriate control (i.e. coffee beans cannot be consumed without pouring boiling water on them, which would kill any bacteria on the bean. By preparing coffee the consumer is inherently applying the necessary control)

2. You rely on your customer, who is subject to this subpart, to ensure that the hazard is mitigated. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

3. You rely on the customer who is not subject to this subpart to eliminate the hazard. You must:

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that the customer is following the procedures you have provided, which will eliminate the hazard.

4. You rely on the customer to provide assurance that the food will be processed to control the hazard by a subsequent entity in the supply chain

i. Disclose in writing that the food is "not processed to control [identify hazard]" and

ii. Annually obtain written assurance that your customer will:

A. Disclose in documents accompanying the food that it is "not processed to control [identify hazard]"

B. Will only sell to another entity that agrees in writing that it will mitigate the hazard and obtain similar written assurance from subsequent customers.

5. You have established and implemented a system that ensures control of the hazards in your product, at the distribution step.

Note: You must document any circumstance (related to the section above) that applies to you, including written assurances from customers.

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This Article is For You if…

∆ You manage a facility that makes, holds, or packs food.

∆ You are developing a food safety plan or HACCP plan.

∆ You have identified a hazard in your hazard analysis

∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)

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Resources

Food Safety Plan Templates

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More About Food Safety Plans

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References

These requirements are a part of our comprehensive Food Safety Plan Guide

What you need to know:

• A hazard analysis is the process of identifying all of the hazards present in your process that could potentially cause a customer injury.

• Creating a Hazard Analysis is the first step in developing a food safety or HACCP plan.

• You can read the requirements below or just use our self-guided hazard analysis template

Requirements for a Hazard Analysis:

1. You must conduct a hazard analysis for each type of food manufactured, processed, packed, or held at your facility.

2. Your hazard analysis must be written.

Steps in Creating a Hazard Analysis

1. Download our Hazard Analysis Template

It’s available for free here, and it will be much easier if you can follow along.

Example Process Flow - Each box corresponds to a process step.

2. Identify the steps in your process from start to finish.

It’s important that you have every step in your process identified so that you don’t miss anything in your hazard analysis. Often, it’s easiest to conduct a process flow diagram to identify all of the steps in your process.

3. Conduct a Hazard Identification:

In this step, you review all of your process steps and identify if there are any hazards present at each step. For each step, you will consider 3 types of hazards:

• Biological Hazards (bacteria, parasites, etc.)

• Chemical hazards (i.e. toxins, pesticides, food allergens)

• Physical hazards (i.e. stone, glass, metal fragments)

Your hazard identification should also include hazards that could be present in the food because:

• The hazard occurs naturally (i.e. toxins in fish)

• The hazard may be accidentally introduced (jewelry from employee falls into food)

• The hazard may be introduced intentionally for economic gain (i.e. sabotage by a competitor)

4. Conduct Hazard Evaluation

The hazard evaluation is the last step in creating your Hazard Analysis. Here, you must evaluate each hazard that you identified to assess the probability that it would occur if left unaddressed.

If the probability is high that this hazard would cause an injury if unaddressed, then you must implement a “preventive control”.

You also must consider the effects of these things in your hazard evaluation.

• Formulation of the food

• Condition and design of the facility

• Raw materials and other ingredients

• Transportation practices

• Processing procedures

• Packaging and labeling activities

• Storage and distribution

• Intended use of the product

• Sanitation, including employee hygiene

• Any other relevant factors (i.e. weather, natural toxins)

• Environmental pathogens whenever a ready-to-eat (RTE) food is exposed to the environment before packaging.

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This Article is For You if…

∆ You manage a facility that makes, holds, or packs food.

∆ You are developing a food safety plan or HACCP plan.

∆ You are subject to Part 117 Subpart C (very small businesses are exempt from this requirement)

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Resources

Hazard Analysis Template

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More About Food Safety Plans

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References

These requirements are a part of the Current Good Manufacturing Practices that relates to Facility Requirements. You can see the full guide to cGMPs here

Plants & Grounds

Grounds must be kept in a condition that protects against contamination. Methods include:

1. Eliminate conditions for breeding/harboring pests
2. Maintain roads, yards, parking lots
3. Drain areas (i.e. puddles) that may breed pests or contribute to food contamination
4. Even if the grounds aren’t in your control, you must still mitigate contamination hazards.

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Plant Construction and Design

The space must be suitable in size, construction and design for food production.

1. Must have adequate space for equipment and storage.

2. Must allow you to take precautions which reduce allergen contamination and food contamination (for example -- by chemicals, filth, other materials). Ways to eliminate contamination include separating operations by: location, time, partition, air flow systems, dust control system, etc.

3. Protect food that is stored outside in bulk containers:

4. Floors, Walls, Ceilings must be constructed in a way that allows them to be cleaned. The construction of the space must allow employees to do their jobs and not contaminate food, packaging, and work areas.

5. There should be adequate lighting in all food and employee areas (including food storage areas and employee locker rooms). All bulbs and glass that is suspended over areas where food is exposed should be shatter resistant.

6. There should be adequate ventilation to minimize dust, steam, odors, and vapors.

7. Provide screens or other protection against pests (door sweeps, air curtains)

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Sanitary Facilities

Plumbing

Water Supply must be from an adequate source. Running water must be of a suitable temperature and pressure and be provided in all food processing/cleaning areas.

Plumbing must

1. Carry adequate amounts of water around the plant.
2. Remove sewage from the plant.
3. Avoid contaminating food, equipment, water supply, utensils, ec.
4. Provide floor drainage in spaces where floors get very wet
5. Avoid back flow between plumbing systems

Sewage Disposal: Sewage must be disposed of adequately

Toilet Facilities: Each plant must have clean toilet facilities.

Hand-washing facilities: Each plant must provide hand washing facilities.

Rubbish: store rubbish to minimize odor, pests, and contamination

ATP Testing

ATP testing is a popular method for determining the effectiveness of a sanitation program. Check out our article on ATP testing and Environmental Monitoring to learn more.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ You are seeking to understand facility requirements for your FDA-regulated food business.

∆ You manage a facility that makes, holds, or packs food.

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More About Operating Requirements

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

These requirements are a part of the Current Good Manufacturing Practices that relates to Processes and Controls. You can see the full guide to cGMPs here

Requirements For Processes and Controls

Below are the processes and controls requirements for FDA regulated food businesses.

General Requirements

1. All operations involving food must align with sanitation principles.

2. Quality control must be used to ensure food and packaging is safe.

3. One or more competent individuals must be responsible for sanitation

4. You must protect your food from allergens and contamination.

5. Testing must be used to identify sanitation failures or possible product contamination.

6. Any contaminated food must be discarded or treated to eliminate the contamination.

Raw Materials & Ingredients

1. Ingredients must be inspected for cleanliness and stored safely. If necessary, raw materials should be washed using clean water.

2. Ingredients must be safe for consumption or treated to make them safe (i.e. washed or cooked).

3. Ingredients susceptible to toxins must comply with FDA regulations.

4. Ingredients that are contaminated must comply with FDA regulations if they are to be used.

5. Ingredients must be held in containers that prevent contamination and at an acceptable temperature and humidity level.

6. Frozen ingredients must be kept frozen.

7. Ingredients stored in bulk must be safe from contamination.

8. Ingredients that contain allergens must be identified and held in a way that prevents cross-contact.

Manufacturing Operations:

1. Equipment must be maintained in clean condition.

2. All operations should be controlled to minimize growth of bacteria, contamination and spoilage.

3. Food requiring refrigeration must be refrigerated throughout the operation.

4. Measures used to prevent bacteria growth (i.e. cooking, sterilizing, refrigerating) must be adequate.

5. Re-work must prevent contamination and bacteria growth.

6. When ingredients are unprotected they must not be handled in a way that could cause contamination. Food on conveyor belts must be protected.

7. Equipment, containers, and utensils must be constructed and used in a way that doesn’t contaminate food.

8. You must take measures to protect your product from metal or foreign objects.

9. Contaminated food must:

i. Be disposed of OR

ii. Re-worked and re-examined,

10. Food that is being processed must be protected from contamination.

11. Heat blanching --if used-- must be performed properly

12. Foods that are used repeatedly (i.e. dipping sauces, breading) must be protected from contamination and bacteria growth

13. Filling, assembling, and packaging processes must not contaminate food.

14. Dry foods that rely on low moisture for safety must be sufficiently dry.

15. Acidified foods that rely on acid for safety must be sufficiently acidic (pH≤4.6)

16. Ice that touches food must be food quality.

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

This Article is For You if…

∆ Your business is regulated by the FDA

∆ Your business makes, packs, or holds food.

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More About Operating Requirements

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

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These requirements are a part of the Current Good Manufacturing Practices. You can see the full guide to cGMPs here

Personnel Requirements

Employees working in food processing spaces are subject to basic requirements about disease control and cleanliness. The aim of these requirements is to make sure a food processor does contaminate their own food product which could cause a customer to become sick.

Disease Control:

Sick employees must be excluded from operations that could result in food contamination.

The typical way of doing this implementing an Employee Hygiene Policy that excuses sick employees from work. This may require food production employees who have been exposed to a serious contagious illness to refrain from working until they are no longer contagious.

Cleanliness:

This section states that employees must have clean practices

1. Clothing that protects against contamination
2. Adequate personal cleanliness
3. Hand washing
4. Removing unsecured jewelry
5. Wearing gloves in a safe manner
6. Wearing hair restraints
7. Storing other belongings in areas where food is exposed/equipment is washed.
8. Not eating food, chewing gum, drinking beverages, or using tobacco in food areas.
9. Taking other precautions

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Exemptions

This section applies to most traditional food processors that fall under FDA jurisdiction. However, there are some notable exceptions.

• Farms

• Fishing Vessels

• Establishments who solely hold and transport agricultural products

• Establishments who only raw process (i.e. shell or dry) nuts.

• Mixed-Type farm facilities (defined in §1.227)

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This Article is For You if…

∆ Your business is regulated by the FDA

∆ You have employees who work in a space where food is handled, packed, or produced.

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References

Guide to Current Good Manufacturing Practices (117 Subpart B)

Introduction

Great! You have already confirmed that your business is regulated somehow by the FDA. 

The easiest way to understand what regulations apply to your business is to identify what kind of food you make.

Some foods are subject to special requirements. If your business produces one of the food types below, click the link to learn about their special requirements. Otherwise, keep reading

Do you make one of these specially regulated foods?

• Dietary Supplements

• Fish / Fishery Products (Seafood)

• Juice

• Animal Food (Includes pet treats)

• Infant Formula

• Bottled Water

If you make one of these foods, check out our section on Specially Regulated Foods 
Otherwise, your product likely falls under Part 117 (See Below)

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Part 117 Overview

If you are producing human food, then you are most likely governed under Title 21 -- Chapter 1 -- Subchapter B -- Part 117.  This section contains the majority of requirements for typical food producers.

What You Need To Know To Be FDA Compliant:

Everything a food producer needs to know is located in Subpart B. To find exactly what you're looking for, read the sections below:

Subpart B -- Current Good Manufacturing Practices: This contains Requirements for Facilities, Employees, and Sanitation.
     Guide to Subpart B

Subpart C -- Hazard Analysis and Risk Based Preventive Controls: This section outlines the requirements for a Food Safety Plan and other requirements related to the implementation of preventive controls.
    Guide to Subpart C

Subpart F -- Requirements Relating to Records that Must Be Established and Maintained: This section dictates the record keeping requirements for food businesses. 
     Guide to Subpart F

Subpart G -- Supply-Chain Program: This section outlines the requirement for verifying supplier partners and documenting this process.
Guide to Subpart G

Other Parts of 117:

These sections relate to a minority of food processors. In case you are interested, I have linked them below:

Subpart A -- General Provisions:This section contains definitions, exemptions, and the training requirements for employees working in a food production space.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart A: General Provisions

Subpart D -- Modified Requirements: This section describes modified requirements that apply to Qualified Facilities and Storage Facilities.
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart D: Modified Requirements

 Subpart E -- Withdrawal of  a Qualified Facility Exemption: This section describes how a business would transition from being exempt to provisions of the code to non-exempt status. This only applies to businesses who previously but no-longer apply for the Very Small Business Exemption
Source Text: Title 21 -- Chapter 1 -- Subchapter B -- Part 117 -- Subpart E: Withdrawal of a Qualified Facility Exemption

This Article is For You if…

∆ You make or pack food that is consumed in the US.

∆ Your food product enters interstate commerce

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References

FDA Human Food Regulation (Part 117)

Products Requiring Supplemental Registrations & Notifications

Specific product types require additional registration beyond a Food Facility Registration. They include:

• Acidified Foods & Low-Acid-Canned-Foods

• Infant Formula

• New Dietary Ingredient

• Shell Egg Producer

Acidified Foods & Low-Acid-Canned-Food Registration

This category of foods includes many fermented foods, sauces, salsa, and other food that are kept shelf-stable in a sealed container.

A commercial processor created Acidified Foods (AF) or Low-Acid-Canned-Foods must file with the FDA. Their filing will include the following information:

• Establishment details

• List of food processed

• Processing method

If you are unsure whether this definition applies to your product, check out the glossary below or this guidance document from the FDA:

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Infant Formula Registration

If you produce or distribute infant formula, then you must register prior to introducing your product to interstate commerce.

**Note that some of these filings must be made 90 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This registration will require the following information:

• Establishment details

• Product Details

  • name and description

  • An explanation of why it is a new infant formula

  • The quantitative details of the product

  • A description of any reformulation of the product or change in process.

  • Assurance that the infant formula will not be marketed unless in meets FDA criteria.

For specific details about infant formula registrations, click here

New Dietary Ingredients

Dietary supplements that contain a "new dietary ingredient" (anything not marketed before 1994) must notify the FDA about those ingredients. This notification includes information that the new ingredient will be safe to consume as prescribed by the product label.

**Note that this filing must be submitted 75 days prior to the product entering interstate commerce so that the FDA may have the chance to respond**

This notification will contain the following information:

• Your personal details

• The name of the new dietary ingredient

• A description of the supplement that contains the new product

  • Levels of the new ingredient in the product

  • Ordinary conditions of use

  • History or evidence of safe use (i.e. scientific literature, historical evidence, etc.)

Consider consulting this FDA resource about New Dietary Ingredients in Dietary Supplements

Shell Egg Producers

Producers of shell eggs (i.e. an egg hatchery or poultry house) must register the details of their facility. This is due to the high frequency of food borne illnesses associated with shell eggs, largely due to temperature abuse and the transportation of this product. This registration will require the following details:

• Establishment details

• Dates/Size of operations

• Owner information

For more information about requirements for shell egg producers, click here

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Contents

Acidified Foods & Low-Acid-Canned-Foods
Infant Formula
New Dietary Ingredient
Shell Egg Producers

More About FDA Registration

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References

Is Your Product an Acidified Food or a Low-Acid-Canned Food?

What You Need to Know about CBD and the FDA

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

This article provides a background on the FDA's current regulation of CBD. To learn about more recent updates, see 5 Things we Learned from the FDA Update on CBD Foods

CBD is a Drug Ingredient, Not a Food Ingredient or a Dietary Supplement

CBD (Cannabidiol) is an active ingredient in an FDA-approved drug (Epidiolex) which was subject to the rigorous drug-approval process. According to FDA regulation, substances which are active ingredients in a drug cannot be introduced as ingredients into food or marketed as dietary substances.

Even if the FDA hasn't yet approved the drug yet, its active ingredients are typically disallowed as food or dietary supplement ingredients insofar drug trials are underway and publicly known.

This is the crux of the FDA's argument for disallowing CBD in food products prior to the June 2018 approval of Epidiolex, a CBD-based epilepsy drug. In 2017, the FDA sent warning letters to producers of CBD-infused food and cosmetic products, arguing that the use of CBD was illegal because publicly known drug trials for Epidiolex were already underway.

CBD Dietary Supplements are easy to come by

There is an exception to the rule: if the substance in question was marketed as a dietary supplement or conventional food ingredient before it became an drug ingredient, then it may continue to be used as a food ingredient. In the case of CBD, the FDA has determined that there isn’t sufficient evidence of it’s historic use as a food ingredient.

Still, in late 2018, the FDA acknowledged that they have the authority to approve the use of a pharmaceutical ingredient in a food or dietary supplement. And according to the commissioner’s statement in December 2018, they are currently deciding whether to pursue this as it relates to CBD (and THC too). What would compel the FDA to allow CBD in FDA-regulated foods? At this point, it’s unclear.

Bottom Line: It is unlawful to sell any food or dietary supplement containing CBD if that product enters interstate commerce.

CBD-Containing Cosmetics

CBD-containing cosmetics are widely available both online and in retail locations nationwide. What’s the legal status of CBD cosmetics with the FDA?

Are CBD Cosmetics Considered Drugs?

The difference between a cosmetic and a drug is whether the product "affects the structure or function of the body." Simply, if the product causes any sort of physiological change that is beyond "cleansing, beautifying, promoting attractiveness, or altering the appearance", then it is considered a drug.

The FDA Defines a cosmetic as

“(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap."

For example anti-perspirant is considered an over-the-counter drug because its effects are not merely cosmetic: anti-perspirant causes a physiological change -- it blocks our pores-- which prevents the wearer from sweating.) While deodorant would be considered a cosmetic (it’s merely perfume), sunscreen is considered a drug.

CBD has a physiological effect on the body —it’s the active ingredient in the FDA-approved prescription drug Epidiolex — so any product containing CBD would seem be classified as a drug.

But here’s the twist: while the FDA has made this argument as it relates to food and dietary supplements, they have not (as of 2020) made it for cosmetics.

So what is the FDA stance on CBD Cosmetics?

The FDA does not explicitly disallow cannabis products in cosmetics and they aren’t going after CBD cosmetic companies (so far).

However, the FDA has made it clear that they intend to take enforcement action brands who make false claims about their drug’s ability to treat or cure a disease. CBD cosmetic brands which list the therapeutic effects of CBD or directly state its ability to alleviate certain symptoms will continue to receive warning letters (see the FDA Warning Letter to Rooted Apothecary)

Bottom Line: CBD cosmetic brands are unlikely to be subject to FDA enforcement insofar as they do not make drug-claims on their product or in their marketing.

For more information, see

FAQ - CBD and FDA Regulation

Does it matter that the CBD is hemp-derived?

No. Regardless of the origin of the CBD, substances which are active ingredients in a drug cannot introduced as ingredients into food or marketed as dietary substances.

What if my CBD/THC product doesn't enter interstate commerce?

If a food product's packaging and ingredients (including the CBD) were sourced entirely in-state and your product is sold in-state, then the product may not be considered as participating in inter-state commerce.

In this case, the product would not be subject to FDA regulation. (Learn more in our article Does the FDA Regulate My Food Business?)

However, this doesn't mean you're in the clear -- check with your state and local health authorities to confirm there's no local law that automatically adopts FDA regulation at the local level or expressly prohibits CBD as a food ingredient.

Why are some companies allowed to sell CBD in foods?

They're not. Many food companies are operating in violation of FDA regulation. The FDA has sent warning letters to food products which contain CBD or cannabis-derived ingredients. However, due to the reactive nature of the FDA and a large array of responsibilities, not all of these companies have been approached.

The FDA regulates all types of new ingredients that are added to food. Whenever any sort of new compound (either a dietary supplement or something that wasn't considered "food") is added to a food, the FDA must first approve that new dietary ingredient.

Can hemp be used as a food ingredient if it doesn't contain CBD or THC?

Yes. There are hemp products that do not contain CBD or THC, such as hemp-seed-derived food ingredients. Three of these products have been added to the list of "generally recognized as safe (GRAS)" ingredients. They are:

1. Hulled hemp seed

2. Hemp seed protein powder

3. Hemp seed oil

The reasoning is that they do not contain CBD or THC. If these food ingredients are manufactured in a way that is consistent with FDA regulations, then they are allowed as ingredients in FDA-regulated foods.

Is CBD GRAS? (Generally Recognized as Safe)

No. While other hemp products (see above) are considered GRAS, cannabidiol (CBD) is not one of them.

If you’d like to check whether a specific ingredient is allowable in food, consider searching this database of .

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More About CBD

Table of Contents

What You Need to Know

CBD is a Drug not a Food

CBD Cosmetics

FAQ

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Resources

FDA Overview of Cannabis Regulation

Read the FDA Commissioner's Dec. 2018 Statement on CBD and the FDA

Read this 2017 letter from the FDA to a CBD-infused candy company

FAQ from the FDA about Marijuana and related products

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As incubator kitchens (commonly known as "shared-kitchens" or "commissary kitchens") pop up at an unprecedented rate, little attention has been paid to the regulation of these multiple tenant food processing facilities.

In this presentation to the Central Atlantic States Association of Food and Drug Officials, Ned Klein explains the regulatory landscape surrounding this business model and how food businesses and shared kitchen operators alike can protect themselves.

Bottom Line: FSMA has a severe impact on shared kitchens operate. For more about FSMA and food businesses, check out our detailed FSMA Guide

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Contents

If You Warehouse and Distribute Only Packaged Foods

If You Import Foods

If You Transport Food Yourself or Hire a Carrier

If you warehouse and distribute only enclosed, packaged foods...

Then you are exempt from two major components of FSMA :

• 117 Subpart C which requires you to have a hazard analysis and a food safety plan, and

• 117 Subpart G, which requires you to have a Supply Chain Program.
  

This means you don't need a food safety plan, a recall plan, or a supplier verification plan.

What You Need To To:

Control Food Temperature

If you warehouse/distribute food that is kept refrigerated or frozen, then you must have systems to ensure that proper temperature is being kept at all times. Specifically, you must:

• Establish temperature controls. This means outlining what are safe temperatures for refrigerated and frozen foods in your space and having this information written.

• Regularly monitor temperatures of all of your refrigerated spaces (including vehicles) either manually with a log or through an automatic temperature monitoring system.

• Take corrective action. If there is a temperature deviation that impacts the product, then you must take a corrective action. This means producing a written record showing that you corrected the problem, evaluated the product, and reduced the likelihood that it will recur.

• Verify your temperature controls. You must calibrate your thermometers or check them for accuracy to make sure you're recording information accurately.

• Verify your records. This means a supervisor must review the temperature logs (from your trucks or walk-ins) to make sure there was no deviation from the acceptable temperature ranges. You must also review corrective action records within 7 working days and calibration records within reasonable time.

• Keep Records. You must be able to show that you have records of temperatures records, any corrective actions, and that they have been verified.

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If you Import Foods From other Countries…

You are most likely required to implement a Foreign Supplier Verification Program (FSVP). Check out our guide to FSVP.

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If you transport food yourself or hire a carrier to transport it for you…

If you are in any way involved in the transportation of food, then you are subject to the Sanitary Transportation of Human & Animal Food. We let you know exactly what you need to do to comply with that in our guide to Sanitary Transport

This article is for you if…

∆ You are an FDA-regulated food distributor

∆ You are an FDA-regulated food business and you distribute food yourself

∆ You are unsure about what FSMA requirements apply to you.

Find the Right Tools

More About FSMA

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