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January 2, 2024
Each quarter, I provide updates on notable FDA warning letters. Understanding enforcement trends is essential for being a savvy marketer, regulatory affairs professional and dietary supplement executive. Have you wondered why FDA issues warning letters to certain companies and not others? FDA likes to make examples of companies not following the rules in areas they want to focus on, many of which I review here. Staying ahead of trouble is one of the critical and fun reasons to follow enforcement trends.
- More rigid interpretation of cGMPs (current good manufacturing practices) related to finished product identity and composition testing.
- Drug-spiked product warning letters.
- Enforcement of TikTok disease claims and Federal Trade Commission crackdown on influencers not disclosing a material connection. (This is a repeat from last year.)
- Homeopathic products will continue to be scrutinized.
Below are my 2023 enforcement predictions from the Q4 2022 warning letter roundup. Let’s review how right or wrong my predictions were.
1. Continued enforcement of biomarker claims related to blood sugar and heart disease (e.g., lowers A1C).
- This prediction was pretty good. We’ve seen numerous companies cited for these types of warning letters. Interestingly, the biomarker claims cited have been related to heart disease, but I wonder if we’ll see an expansion of this into cognitive and liver biomarkers such as creatinine in 2024.
2. A continued increase in CBD warning letters, especially for those containing delta-8.
- I was way off with this prediction as there were just 15 CBD and delta-8 warning letters in 2023 compared to 34 the previous year.
3. Enforcement of TikTok disease claims and FTC crackdown on influencers not disclosing a material connection.
- FDA has yet to cite companies for making disease claims on TikTok, so I was wrong with this prediction. FTC, however, did start to crack down on TikTok influencers, as we saw with the recent sugar and sweetener trade group letters. I’m carrying this prediction over to 2024, though, so in my opinion, companies and influencers going “non-compliant crazy” on TikTok should beware.
4. FDA crackdown for claims made on affiliate and distributor websites.
- There were a lot fewer affiliate-related warning letters last year than I thought there’d be, but Amazon and Walmart received a total of four letters for distributing adulterated or uncompliant products. These letters show even large distributors may be called out for non-compliance.
Ophthalmic (eye) products: There were 22 ophthalmic FDA warning letters in 2023 compared to just seven in 2022. Ophthalmic products are drugs that are added to the eyes, but supplement and cosmetic companies can learn from this enforcement trend. Many of the warning letters were issued because the product was making disease statements like glaucoma, was not registered as an OTC, or the product contained unallowable ingredients such as homeopathics not generally recognized as safe and effective (GRASE), or ingredients like MSM that don’t belong in the eyes.
Distributor requirements: Many of the warning letters involved companies that were distributing non-compliant products. This includes many names we all recognize, like Walgreens, CVS Health and Amazon, showing distributors are responsible for ensuring the products they sell are compliant. I expect more distributor enforcement for non-compliant, adulterated products and supplements with disease claims in 2024. Being a distributor, especially one that handles the product shipping, is not a “loophole” for avoiding compliance.
Improper 483 responses: Most responses to FDA Form 483 observations can be addressed before FDA resorts to issuing a warning letter. Below is FDA’s statement from a recent warning letter that is all too common. The company’s 483 response did not include all the updated information required to prove the issue has been corrected.
From the FDA warning letter: “We are unable to evaluate your corrective action because you have not provided revised ‘Raw Materials Spec Sheet’ for the components used in the manufacture of the …. dietary supplements, nor have you provided finished product specifications for each of the products.”
FDA reviews websites around the time of the closeout of the Form 483, which can be up to 12 months after the initial cGMP inspection. This is a friendly reminder to re-review online marketing if a company has recently been visited by FDA; disease claims can “tip the scale” to a warning letter when a company has provided mediocre 483 responses. This is one of the reasons I developed Apex Compliance, which helps companies find the high-risk “forgotten regulatory landmines” before they become issues.
Improper specifications: This has always been one of the most commonly cited 483 citations, and the trend continued in Q4.
One of the core principles of supplement cGMPs is verification. For example, if an ingredient arrives at a facility, the firm must develop testing parameters that ensure that it is the correct ingredient and is not contaminated with microbials, heavy metals, or with other substances like drugs. This is referred to as the “Big Five” by industry expert Larisa Pavlick (identity, purity, strength, composition, and limits for potential contaminants). Each ingredient should have a specification for these items, a testing method and a result. This is also required for labels, packaging components and formulas. FDA warning letters continue to cite firms for not meeting these fundamental cGMP requirements.
Meeting these verification requirements is relatively simple for ingredient identification and potency testing but is complex and challenging when testing finished product composition, as discussed in this CHPA podcast with myself, Josh Long and Larisa Pavlick.
Minor labeling issues: Recent warning letters have shined a light on essential labeling requirements that some regulatory professionals may inadvertently overlook. These won’t typically result in a warning letter, but they do wave a flag at FDA, inviting more scrutiny. Here are some key enforcement reminders.
- Serving size: A serving size is the maximum amount consumed in one sitting. For example, directions that state “Take 1-2 capsules daily” is a two-capsule serving size. This is the amount that should be used in the Supplement Facts panel. 21 CFR 101.36(b)
- Supplement Facts panel format: FDA continues to cite some minor but important oversights such as supplement fact panel line thickness and ensuring “Supplement Facts” is set the full width of the fact panel. Here are compliant supplement fact panel examples from FDA.
- Forgetting the standard disclaimer next to structure-function claims has been a common citation in recent warning letters. 21 CFR 101.93(d)
- Incorrectly listing stevia as a sweetener in “Other Ingredients.”
From FDA warning letters: “Stevia must be listed in the Supplement Facts label as a botanical with a plant part designated if it is used as a dietary ingredient. If being used as a sweetener, only a GRAS ingredient may be added to a dietary supplement, such as a purified stevia extract (e.g., ‘rebaudioside A’).”
There were 55% fewer CBD and delta-8-related warning letters in 2023 compared with 2022. This was primarily related to an apparent shift in agency priorities and less CBD and Covid marketing enforcement than during the pandemic. Also, the “green rush” of previous years has passed, and many inexperienced entrepreneurs who were making blatantly risky marketing mistakes have moved on to other markets, such as psychedelics.
So, what will 2024 bring for CBD?
I expect delta-8 and CBD enforcement to continue, especially for companies who still have high-risk Covid and opioid-related statements lurking in their marketing. For example, this recent warning letter cited Covid-related claims made in a three-year-old blog post. I also expect companies to be targeted that sell delta-8, delta-9 THC and other psychoactive cannabinoids in child-friendly formats, such as candy and chips.
Follow Warning Letter Wednesday for weekly updates on interesting warning letters.
Asa Waldstein is a certified clinical herbalist and a 20-year dietary supplement executive who has helped oversee three FDA inspections with no Form 483s. Waldstein is principal of the consulting company Supplement Advisory Group, a boutique group focusing on marketing risk analysis and practical marketing solutions for the web and social media. He also is the founder of the compliance software company Apex Compliance, chairs the American Herbal Products Association's (AHPA) Cannabis Committee and is a Naturally Boulder board member. Learn more and contact him at AsaWaldstein.com.
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