FDA Warning Letters 2015 Summary

By Curtis Walcker, M.S.
February 4, 2016

In 2015, the FDA issued 80 Warning Letters (WLs) to dietary supplement (DS) companies. This was a 12.68% increase on the 71 issued in 2014. The increase can in part be attributed to the large number of WLs issued to companies marketing products adulterated with non-dietary ingredients such as beta-methylphenethylamine (BMPEA) and 1,3-dimethylbutylamine (DMBA).

Number of 2015 Warning Letters



Because many of the WLs sent were for the non-dietary ingredient violations, and inspections for those products generally involved review of the labels for ingredients, inspection types categorized as ‘labels’ were significantly higher than other categories in 2015. This did not equate to a proportionally high number of WLs citing label violations.

Inspection types resulting in WLs expanded in 2015. Social media sites have been receiving more scrutiny. The FDA is also looking for claims on online retail sites where companies are marketing DSs, such as Etsy and Amazon.

FDA Inspection Types


Geographic Locations

Below are heat maps of the continental Unites States showing the prevalence of WLs received by DS companies by State, as well as which States they were sent from. In 2015, companies in Florida, California, and Utah received the most WLs. The FDA tended to send the most WLs out of the District Offices located in Maryland, California, and Colorado.




Disease claims were the most cited violation in WLs for 2015. Non-dietary ingredient adulteration violations were in a distant second place due to some crackdowns on particular ingredients. Violations in current Good Manufacturing Practices (cGMPs) and labels were cited in more than 20 WLs each, indicating continued challenges for companies in both areas.



Disease Claims

The FDA cited disease claims violations from a variety of places, demonstrating their increasing concern about what companies are saying and where they are saying it. Product names that were disease claims topped the list along with disease claims made on Facebook. New areas in 2015 include e-books, LinkedIn, and Tumblr.



Not much changed in 2015 from previous years in terms of the types of disease claims marketers are illegally using. The top 15 should be no surprise. Combinations of many of these showed up in several of the WLs. The FDA generally only cites disease claims violations in WLs that are clearly explicit.




Violations of every Subpart of the cGMP regulations were cited in the 2015 WLs. Production & process controls and quality control Subparts saw the most violations. Companies failing to have adequate master manufacturing records (MMRs) and batch production records (BPRs) continues to be a major problem.





Of the 80 DS WLs issued in 2015, nearly 30% of them cited violations for product labels. This number is likely deceivingly low because so many of the non-dietary ingredient WLs seemingly failed to also cite label violations for the offending products. All 23 WLs citing label violations highlighted errors within the information panels; only 13 involved errors within the principal display panels.


One of the biggest label violations of 2015 involved matching the label’s recommended usage of the product to the declared Serving Size. The majority of the top 10 violations were made within Supplement Facts panels. Failing to include proper contact information for the reporting of serious adverse events associated with product use is a prevalent problem among labels.
Note: All information in this article was derived in good faith and is believed to be accurate. Data was collected from all 2015 FDA Warning Letters issued to dietary supplement companies posted on the FDA’s website as of February 3, 2016.

Structure/Function Claims Basics

By Curtis Walcker, M.S.
December 9, 2015

Structure Function Claims BasicsCommunicating the features and benefits of your dietary supplements is a critical success factor. Although this can be done in several ways, the most powerful is usually through the use of structure/function claims. A common misnomer about these claims is that virtually anything can be said as long as the FDA disclaimer language is added to the label or labeling. Unfortunately, this is far from the truth. There are regulations that put significant limitations on what can be said, and it is truly an art to not only saying things compliantly, but also in ways that are meaningful to consumers. Here are some of the most basic aspects of structure/function claims.

What are structure/function claims?

Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of humans, or characterize the documented mechanism(s) of action by which a nutrient or dietary ingredient acts to maintain such structure or function. Importantly, they cannot be disease claims. Structure/function claims may also relate to nutrient deficiency diseases, or describe the effect of the dietary supplement on general well-being.

What are disease claims?

Dietary supplements and their ingredients cannot be marketed with the intentions to diagnose, mitigate, treat, cure, or prevent diseases (other than classical nutrient deficiency diseases). Doing so creates disease claims. By the definition given in 21 U.S.C. 343(r)(6), “disease” is damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.

Q: Which of the following is the disease claim?
1) Product X treats diabetes.
2) Product X promotes healthier blood sugar.

A: Both are very likely to be considered disease claims. Did you choose 1? Disease claims can be explicit or implied. They need not mention specific disease names such as diabetes.

What laws and regulations govern structure/function claims?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law states that a dietary supplement may bear structure/function claims and provides their requirements. Further, 21 CFR 101.93 also restates these requirements.

What are the requirements for using structure/function claims?

  1. You must have substantiation that the claims are truthful and not misleading, and you must have this substantiation before you make the claims.
    • Refer to the FDA and FTC guidance documents for preparing competent and reliable claims substantiation, or get help from someone who can prepare these files for you. You do not want to be caught without them.
  2. You must notify the FDA that you are using the claims within 30 days of first marketing your product.

    Q: Do you really need to do this?

    A: Yes. Many companies overlook this important requirement for making structure/function claims.

  3. You must include the mandatory disclaimer for structure/function claims.
    • Text for the disclaimer when one claim is present: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
    • Text for the disclaimer when more than one claim is present: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
    • The disclaimer must be placed adjacent to the claim(s) with no intervening material or linked with a symbol (e.g., an asterisk) at the end of each claim that refers to a symbol placed adjacent to the disclaimer.
    • On product labels and labeling, the disclaimer must appear on each panel or page where structure/function claims are made.
    • The disclaimer must be set off in a hairline box when it is not adjacent to the claim(s).
    • The disclaimer must be in bold type and no smaller than one-sixteenth inch.

While these basics do not cover everything you must know when making structure/function claims, they give you a good start towards regulatory compliance. For a bit more, see our April, 2015 article Supplements Claimed to Treat 100+ Diseases. It highlights some places claims exist, as well as some of the most prevalent claims cited in FDA Warning Letters.