FDA “Discretionary Enforcement”

Posted in: Legislation & Regulation

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Last March, 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 are some labeling regulations that 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 with the 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.” – FDA Letter

Say WHAT?

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 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 composit 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 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, 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 fair is that?

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 noone’s private info is shown).

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

 

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21 Comments on “FDA “Discretionary Enforcement””

  1. Cindy

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

  2. 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.

  3. Elizabeth

    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 !

  4. Carrie Kennedy

    “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.

  5. 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.

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