FDA “Discretionary Enforcement”

Last March (2017), I sent a Freedom of Information Request to the FDA, asking for details on any decisions they had made to use “discretionary enforcement” on some regulations. It seems that there are some labeling regulations which the FDA has apparently decided not to enforce, but they haven’t really said anything publicly. That may be why we see so many large companies doing things that are flat out against the existing regs. So I decided to get to the bottom of it through a Freedom of Information Request.

Last month, I got an answer back.

“The Office of Food Additive Safety (OFAS) conducted a search and is unable to locate any records responsive to your request.”


They gave me 90 days to file an appeal, which I mailed off today. In it, I listed out 5 different examples of places where the FDA either outright STATED that they were using “discretionary enforcement,” or where there are sure-fire indications that they are doing so. You can read the full letter, but here is a quick summary of the 5 examples I gave:

  1. I found a website page which quotes a response from the FDA about the safety of glitter, which says they are “exercising enforcement discretion” for a “period of time” for non-permitted glitter and mica-based composite pigments.
  2. TKB Trading has a page, which says that the FDA told TKB they are is providing a “grace period” during which FDA “enforcement is discretionary” for glitter.
  3. The fact that the FDA states they require the English common name for botanical ingredients, yet there are thousands of products out there that are using the Latin names primarily or only. I recall seeing a place on the FDA website where they said they wouldn’t cite anyone for using Latin names, but I can’t find it now since they re-did their website a few years ago. All the old links don’t work.
  4. From discussions on a Facebook group, that a big box store allows for a net weight that is +/- 10% of the actual weight. That’s more in keeping with the EU regulations than the “minimum fill” requirements of the FDA. So I asked about that.
  5. Finally, a search of the shelves in any retail outlet shows numerous cosmetics using the name of an ingredient in the name of the product. Have they decided to use “discretionary enforcement” for that regulation?

In my closing paragraph, my closing sentence was:

It becomes very difficult for small business owners and entrepreneurs to follow the regulations when the FDA has made arbitrary and unpublished decisions about what will and won’t be enforced.

That’s exactly how I feel, too! You can get into trouble by not following the regulations, but some of the regulations aren’t really enforced! How is that fair?

I will post any further information I get from the FDA. Hopefully, they will come through with the actual information in order to make it easier for us all to understand and follow the regulations.


Update – July 10th

The FDA FOI office received my appeal on July 6th, and called me. The woman I spoke to was quite friendly and helpful. She said that the letter I received (saying there wasn’t any information and the case was closed) was in error. In actual fact, only ONE of the many FDA sections/departments had found nothing (the Office of Food Additive Safety).

She said that there are still other offices that are (or will be) searching their files for information. Since the original request was not closed, I withdrew my appeal (which apparently is handled on a completely different system).

The next day (July 7th) I received an email from another FDA person (the Government Information Specialist, Center for Food Safety & Applied Nutrition, Office of Regulations, Policy & Social Science) saying that there ARE responses to my FOI request, and he is performing a “disclosure review” (which I assume means mostly making sure that no one’s private info is shown).

So, I should have something back from the FDA about the discretionary enforcement policies within a few weeks!

Navigating the Rules and Regs book by Marie Gale

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!


25 responses to “FDA “Discretionary Enforcement””

  1. Flora T Schaub

    Any new news?

    1. Marie Gale

      No. They apparently don’t have any cohesive plan about their discretionary enforcement.

  2. Did you happen to get anything back yet or am I missing it somewhere? Thank you!

    1. Marie Gale

      Thanks for the reminder. I did get a reply back: it was very unclear and didn’t include any useful information.

      I have to follow up, but it will be a new process. Very difficult to get useful information.

  3. Dorothy Simmons

    Thank you Marie Gale for staying up to date on all of the regulations. I know it is hard work and I greatly appreciate you looking out for us.

  4. Thank you! A million x’s.

  5. Thanks for your time and effort!

  6. How cool!

  7. “Discretionary Enforcement” definitely sounds a little fishy with no definition of who or what is being enforced and through what means. Seriously, with technology there is no reason that the FDA cannot be more clear in definitions, examples, and specific yes/no answers without grey area and bouncing between 26 pages that contradict each other. I’ve found their YouTube channel to have very informative videos at times, but they seem to really steer clear of colorant information on there and focus more on drug information. Thanks for advocating for we, the little people, who are just trying to do the right thing with the information we’re provided. It’s great having someone who can interpret so much misinformation and varying levels of knowledge.

    1. Marie Gale

      All government agencies have “discretionary enforcement.” I’m pretty much of the opinion that the regulations/laws should be black and white and anything that is “gray” should be removed.

  8. Thank you as usual Marie Gale for looking out for all of our small businesses interests!! I know I appreciate all your hard work and frustration !

  9. Go get em Marie! We need clear rules in order to,comply!

  10. maya brown

    Thank you for all that you do.

  11. Girl Power!!! Get em’ Marie!!

  12. Jenna I Campau

    thanks very much for your efforts….I had missed that I should never include any of my ingredients in a soap name. thankfully, I only have one at the moment that violates this and I can quickly re-label.

  13. Thanks so much, Marie!

  14. Margot McDermott

    Thank you for taking action!

  15. Thanks for all you do!

  16. Tina Moenck

    Thank you for all your hard work!

  17. Thank you for being so diligent. It’s greatly appreciated. Small business is challenging enough without having to deal with ambiguity in proper labeling.

  18. Thank you for being our champion!

  19. You are amazing, and my hero!!

  20. Laurie G

    Thank You Marie,…you continue to provide so many with invaluable information!!

  21. Thank you for all of your hard work and dedication that will eventually help us all!

  22. Thanks Marie!

Leave a Reply

Your email address will not be published. Required fields are marked *