Answers to Questions About Regulations

Food Allergens that must be labeled

How do I know what Allergen Controls I must have?

The Federal Allergen Labeling and Consumer Protection Act identified 8 basic proteins as allergens that must be identified on food labels.  However, it wasn't until 21 CFR 117 - Subpart B Food GMPs were finalized that we learned what Allergen Controls we must have.  You can read them directly in the eCFR at 21 CFR 117.10 – 117.110.  

 On-line eCFR 

Food labeling deadlines

What are the enforcement deadlines for the new labeling regulations?

Every company has the option to start using the new labeling regulations now.  Just don't mix old and new regulations on one label!

The enforcement deadlines were pushed out once, but they appear unlikely to move again.  Count on being in full compliance no later than the dates charted here at right.

Read the FDA's Guidance on the deadlines.

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Is it likely that we will have to label sesame as an allergen?

It appears very likely that FDA will add sesame to the current

list of allergens that require labeling.   It is equally likely that sesame oil will be exempt from the requirement because

it is a highly refined oil.   

Now is a good time to see what sesame-related ingredients may be in your products.  Check "tahini" and all spice blends for less than obvious content.


Read FDA Commissioner, Scott Gottlieb's comments

 on sesame (Oct-2018)

Should my label show a Nutrition Facts Box or a Supplement Facts Box?

The distinction between a food and a supplement

 is found at several places within the Federal Food, Drug, 

and Cosmetic Act.  If your product label shows the wrong kind of Box, your product could be deemed "misbranded" 

and that would make your product "adulterated" 

under the law.  ... And if you're product is not made

 using the correct Good Manufacturing Practices (GMPs), that could cause your product to be  "adulterated."

A quick way to start learning about this

 is to read FDA's Guidance on the 

difference between a supplement and a beverage.

FDA Guidance on the Distinction

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Is there a recognized audit standard for dietary supplement manufacturing? Where can I get it?

Yes!  Announced in January 2019, 

there is now an ANSI audit standard for dietary supplements.

The standard is 455-2 – 2018 for Dietary Supplements.

If you plan on getting a 3rd party certification, this is the only one that has the recognition of the American National Standards  Institute (ANSI).   In theory, any FDA-recognized 3rd Party Certification body can perform this audit.  

This standard is recognized and recommended by members

 of the Global Retail and Manufacturers Association (GRMA.)  

Link to GRMA's website

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If my facility is compliant with GMP requirements for making drug products, will our standards pass for supplements?

Drugs and dietary supplements have entirely separate Good Manufacturing Practice (GMP) requirements.   Dietary Supplements are a subset of foods, but they are highly regulated. 

Don't automatically assume compliance with the regulations for Dietary Supplements.  Start a review of 21 CFR 111  or learn about the GMPs by reading FDA's on-line Small Entity Compliance Guide (SECG) for Dietary Supplement Manufacturers.

Here's a link:     SECG for DS Mfrs