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Simplifying Food Regulation

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FDA Reader: Simplifying Food Regulation

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How the FDA Regulates Nutraceuticals
FDA regulates nutraceuticals image post.jpg

What Exactly Are Nutraceuticals?

According to the industry, nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.

But you won’t find the word “nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies that have received warning letters for violating the FDA regulations.

According to the FDA regulations, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

When is a Nutraceutical a Drug?

One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients, a drug is designed to treat illness or disease.

So, in order to maintain classification as a dietary supplement (and avoid the FDA’s strict drug approval process), Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer.

How Are Nutraceuticals Regulated?

Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices -- these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.

Labeling standards for dietary supplements are lumped together with those for foods. However, there are unique expectations for how dietary supplements are marketed and what claims they can make.

For the complete set of regulations on producing dietary supplements, check out the guided question set in 21 CFR 111


 
FDA or USDA Jurisdiction?

What You Need to Know:

  • The USDA regulates the production of meat, poultry and egg products. USDA-regulated businesses are required to have a USDA inspector onsite at all times.

  • The FDA regulates the production of everything else (non-meat foods, unusual meats, and fish products). No inspector is required onsite during production.

  • A business that conducts activities falling under both umbrellas is regulated by both agencies.

  • Food produced and sold in a retail environment (i.e. restaurant, deli) is not typically regulated by either the USDA or the FDA.

How to determine food business jurisdiction: Start with USDA. If you can’t positively identify how it falls under USDA jurisdiction, then it’s regulated by the FDA.

Determining USDA Jurisdiction

The USDA typically regulates the following business types:

  • Slaughterhouses

  • Meat Processors*

  • Poultry Processors*

  • Egg Processors

  • Food processors whose products contain meat*

Food products with the following characteristics are regulated by the USDA.

  • Contains >2% cooked meat

  • Contains >3% raw meat

  • Contains >2% cooked poultry meat

  • Contains >10% cooked poultry skins

*For more detail, see the tables below


Examples of Business Regulation

Business Description of Operations Federal Jurisdiction
Meat Product Processor Producer of frozen meat pies, bone broth, steak delivered via mail USDA
Poultry Product Processor Poultry processor USDA
"Egg Product" Processor Producers dried, frozen, or liquid eggs USDA
Egg processing plant Egg washing, sorting, packing FDA
Slaughterhouse Slaughter and processing of carcasses for sale. *Slaughter for personal consumption is not regulated by the USDA USDA
Commissary for retail outlets A commissary produces deli meats to sell at multiple delis, all owned by the same company. Products are shipped ready-to-eat. FDA
Restaurants and retail establishments Retail establishment that sells meat to typical consumers in retail quantities. Not typically regulated by the federal government
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Examples of Food Product Regulation

Misc Products Regulator
Spaghetti Sauce (2% meat) FDA
Sliced Egg sandwich (closed face) FDA
Shrimp flavored instant noodles FDA
Venison Jerky FDA
Closed Face Sandwiches FDA
Open face sandwiches USDA
Pork Sandwich (open faced) USDA
Corndogs USDA
Frozen Beef pot pie USDA
:
Meat Products Regulator
Cow USDA
Sheep USDA
Pig USDA
Horse USDA
Mules USDA
Goat USDA
Domesticated Birds (chicken, turkey, ducks, geese, guineas, geese) USDA
Wild Birds FDA
Rabbit FDA
Bison FDA
Game animals FDA
Deer, Elk, Moose FDA
Zoo animals FDA
:
Egg Related Products Regulator
Dried Eggs USDA
Frozen Eggs USDA
Liquid Eggs USDA
Egg Substitutes FDA
Dried Custard Mixes FDA
Egg Nog Recipes FDA
Egg Noodles FDA
Milk and Egg Dip FDA
Cake Mixes FDA
French toast Sandwiches Containing Egg FDA
Products containing egg FDA
:

FAQ

What does the USDA inspector do?

The USDA inspector inspects:

  • Slaughtered animals to confirm they were healthy

  • Sanitation conditions of a plant

  • Operations to confirm that they align with the firm’s HACCP plan

  • Product is correctly labeled and packaged to be transported

What it FSIS?

The Food Safety and Inspection Service (FSIS) is the inspection arm of the USDA. So if you see the term FSIS, think USDA.

 
 

This article applies to you if…

∆ You are unsure whether your product is regulated by the FDA or the USDA.

References

USDA Inspection Requirements Overview

USDA Inspection Requirements Overview

FDA vs. USDA Jurisdiction Guide

FDA vs. USDA Jurisdiction Guide


More About Supply Chain


More Posts


Does the FDA Regulate My Food Business?
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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)
:

*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)


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