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.

First Seven FDA Warning Letters for Supplement Labels in 2015

By Curtis Walcker, M.S.
March 29, 2015

fda-warningOnly three months into 2015, the FDA has already issued 19 Warning Letters to dietary supplement companies, seven of which cited product label violations. This is the same number of Warning Letters citing cGMP violations. Five companies were cited for both label and cGMP problems. It is not only clear that the FDA is gathering and reviewing labels during facility inspections, but also that companies continue to struggle to label their products compliantly.

In the seven Warning Letters citing label violations, the FDA managed to find problems with every mandatory label component:

Statement of identity: One company did not identify their product with the term “dietary supplement” as part of a statement of identity.

Net quantity of contents statement: One company neglected to include one. Another stated their net quantity of contents in U.S. Customary terms only.

Supplement Facts panel (SFP): All seven companies had issues with their SFPs. These violations included: no SFP, missing or incorrect Serving Sizes and Servings Per Container, zero amount claims, missing dietary ingredients, missing plant parts for botanical ingredients, and declaring (b)(2)-dietary ingredients out of order.

Ingredient statement: One company was missing ingredients in their statement.

Name and place of business: One company failed to include their name and/or place of business on their label as required.

Other: Two companies neglected to include a domestic address and/or domestic telephone number through which serious adverse events associated with the products could be reported. One company was using two languages on their label, but did not repeat all of the required label information in both languages.

In all of 2013 and 2014, the two most common label violations cited in Warning Letters involved inadequate statements of identity and missing plant parts for botanical ingredients. In 2015, the most common one (three of seven companies had this problem) is having the wrong Serving Size in the SFP. Take notice and review this aspect of your own labels. Here is what you need to know:

  • One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, one unit (e.g., tablet, capsule, packet, teaspoonful, etc).
  • If you recommend one capsule with a meal up to three times per day, your Serving Size is one capsule.
  • If you recommend one to three capsules per day with a meal, your Serving Size is three capsules.