FDA Reader
Simplifying Food Regulation

FDA Reader

FDA Reader: Simplifying Food Regulation

Posts tagged gmp
Understanding Date Labels
Forget everything you think you know about expiration dates.

Forget everything you think you know about expiration dates.

What You Need to Know:

  • Date labels have nothing to do with product safety — they indicate quality.

  • A date label should show the last date of expected peak quality.

  • The recommended wording for is “Best if Used By”

  • The FDA doesn’t require a date label on any food products except infant formula.


Introduction: 

The American food consumer is misreading date-labels and mistakenly throwing out $32 billion dollars worth of food because of it. The FDA is trying to minimize food waste and so they are providing specific guidance to manufacturers about how to write date labels and guidance to consumers about how to interpret them properly.


How to Read a Date Label

What does a date label mean? 

A date label on a food should indicate the last date where the food maintains peak quality and flavor. Date labels are meant to reflect quality not food safety.

A Best-if-Used-By Date “indicates to the consumer that the product may not taste or perform as expected but is safe to be used or consumed”

Wording is inconsistent and confusing to consumers

Wording is inconsistent and confusing to consumers

Can I eat a food after the “expiration date”?

Yes! This is because it’s not an expiration date. A food which doesn’t show signs of spoilage after the specified date can still be eaten. 

Remember that food manufacturers have an incentive for you to only consume products in their “peak quality” because then you will buy their products more often. 

How do I know when a product is unsafe to eat? 

Major food industry groups have endorsed the use of “Use By” to indicate when a product should be discarded for food safety reasons but, as of 2019, the FDA hasn’t taken a stance on this topic.


How to Write a Date-Label

What wording should I use For my Date Label?

The recommended terminology is “Best If Used By”. This indicates that the date is an indicator of quality, not food safety.

The FDA recommends not using words like “sell by” or “expires on” because this obscures the meaning of a date label.

How do I pick a Best-If-Used-By date for my food product? 

Food manufacturers can collect this information by either conducting tests themselves to assess quality. You can do this by storing multiple versions of your product in the recommended storage condition and then tasting them at various time intervals to assess the point when quality begins to decline.

It’s important that you don’t produce, package or store these test-products any differently than you normally would. Finally, your Best-If-Used-By date should pass before any sort of decline in product quality.

You can also enlist a reputable testing lab to conduct testing on your behalf.

Since best-if-used-by dates are an indicator of quality, it’s important that your product is safe for consumption well beyond the date you print on the label.

Do I need to change my packaging If I am not aligned with these Standards?

No. The FDA is trying to minimize confusion to consumers and food waste nationwide. These guidelines won’t be enforced by the FDA — they are simply setting a standard for the industry to adopt.

Should I remove the date label from my product?

You can, but many retailers and some local agencies have their own requirements for printing a “use-by” date of some type. Your best bet is to adopt the FDA-approved wording and print a use-by date that you can stand behind.

Do I need a date label if my product is non-perishable?

Not to satisfy FDA standards (only infant formulas require a “use by” date.) However, large retailers may require a date label on all foods they carry, so it’s worth building the capacity to print date labels, even if you don’t use them at this time.


 
Introduction to Good Manufacturing Processes (GMPs)
This article supports food producers answer the question, “What are GMPs?”

This article supports food producers answer the question, “What are GMPs?”

Introduction to GMPs

Good Manufacturing Practices (GMPs) are the set of production standards that have been embraced by regulators, retailers and consumers in the food and drug industries. 

GMPs provide a basic assurance that a product was produced under industry-standard conditions. Some of the areas addressed in GMPs include:

  • Building & facility conditions

  • Equipment design and maintenance

  • Employee practices

  • Sanitation conditions

  • Raw ingredient sourcing

  • Maintaining strong production controls

  • Records and reports


There are several sets of GMP standards which have been endorsed by different governments. Fortunately although they are nearly identical. Some versions of GMPs include:

  • CGMP* (food) addresses the production of food for the US.

  • CGMP* (drug) addresses the production of pharmaceutical drugs for the US

  • EU-GMP addresses the production of pharmaceutical drugs for the European Union

  • Guide 104 GMP addresses the production of pharmaceutical drugs for Canada

If you are considering aligning your business with GMPs, adopt the set of standards that reflects where your processing is located and where your product will be sold. If this includes more than one set of GMPs, you will want to make sure your operations are aligned with both. Again, they are nearly identical.

*CGMP stands for “Current Good Manufacturing Practices” and is regulated by the FDA.

Food vs. Drug GMPs

In the United States, the FDA defines two distinct sets of GMP standards — Food and Pharmaceutical (Drug).

Food CGMPs: These describe the “methods, equipment, facilities, and controls for producing processed food.” (FDA, 2004). These are meant to ensure that the food is safe to eat.

Drug CGMPs: These assure “the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations”. (FDA, 2018).

The sections below reflect the GMP requirements for food.

Understanding the GMP Certification Process

After a food manufacturer aligns their operations with GMPs, they may consider going through the certification process through a private auditing firm. This is how the certification process typically works:

  1. A manufacturer adopts the GMP standards and makes the required adjustments to align with the standards. Depending on the preexisting practices and conditions, this could take 3-12 months.

  2. The manufacturer chooses a private auditing firm (there are many) to conduct the GMP audit.

  3. The auditing firm conducts the audit, which may include an inspection of the facility and a review of records. 

  4. The manufacturer will correct any areas of non-compliance and, if they achieve a passing score, they will receive a certificate from the auditing firm.

  5. The manufacturer can provide this certificate to prospective buyers as an indication of their alignment with industry standards.

Why You Should Align Your Operations with GMPs

Regardless of whether your business chooses to pursue certification, aligning your operations with GMPs will have the following benefits:

  • Decrease in food safety risk to your customers

  • Lower level of product defects

  • When your buyers conduct supplier verification activities, they will want to want to know that your operations are GMP-aligned — even if you’re not certified


The Benefits of Achieving GMP Certification

  • It will unlock access to the many buyers who require GMP certification from their suppliers.

  • It will satisfy most supplier-verification requirements — meaning less back-and-forth between your team and the companies you sell to.

  • You will have an advantage over competitors who haven’t been certified to this industry standard.

GMP Requirements

For a detailed set of FDA-aligned GMP requirements, see our comprehensive guide to GMPs

Or, you can learn about the individual good manufacturing practices by topic: