Tuesday, April 26, 2016
2015 FDA Warning Letter Analysis
FDA was busy last year with a spat of warning letters to dietary supplement companies that I summarize here. A Warning Letter is more serious than the standard FDA inspection Observation Report.
1. While the number of warning letters is relatively low, under a hundred a year in an industry that has several thousand label-owners, the number has been growing: 67 in '13, 71 in '14 and 80 last year.
That means companies need to pay attention and get ready for FDA inspections and warnings. The best way to prepare? Make sure that your SOPs are up-to-date: www.SOPcertification.com. Your papers must be in order.
2. One area of notable increase is in the number of citations for products adulterated with substances that are not dietary ingredients.
3. The major warning included in the letters related to labeling issues; of the 80 2015 letters, 60 included label issue citations. Website concerns were the second highest, with 43 and facility issues third with 35. Social media was a distant forth with 8.
4. Companies in California, Utah and Florida had the most warning letters.
5. Looking at the 80 letters from the viewpoint of the violations cited we find these:
40 Disease Claims
28 Adulteration, Non-dietary
27 cGMP Violations
23 Label Issues
07 Social Media
05 Caffeine, Powdered
04 Adulteration, Drug
01 Ad Not Substantiated
[My observation: most if not nearly all advertisement non-substantiation issues are raised by FTC, not FDA. Social media is becoming a regulatory concern but the effort to enforce is just starting.]
6. There were a number of disease claims warnings, with the claim being found in different places. In 8 cases, in the product name; in 8 on Facebook; 7 in testimonials; 6 in brochures and 5 in scientific references. One or two also cited meta-tags, YouTube, Pinterest, Tumblr, LinkedIn, eBooks and even printed books.
7. Disease claims on social media sites were primarily limited to Facebook (8) with the other social media sites (LinkedIn, Twitter, Tumblr, Pnterest and YouTube having one each).
8. The disease claims cited most included:
18 Blood Pressure
9. Among label violations specifically, the Supplement Fact Panel had the most citations.
10. Label errors such as serving size, statement of identity and incorrect amounts were among those most cited.
11. The most cited GMP violation was for Part E, Production and Process Controls with Quality Control, QC, a close second.
I conclude from this analysis that we can expect a continued increase in the number of inspections and, consequently, in the number of warning letters. Remember that an Inspection Report is a less formal response from the FDA and will be the usual Agency action after an inspection.
A Warning Letter can be avoided if, in advance of the inevitable inspection, your SOPs are set-up and being implemented, so that the various items listed above do not apply to your operations.
Most important, make sure that your Claims are all DSHEA-permitted Support for Normal Structure and Function Claims. I aim to review claims language within a day or two at most... so send me your Claims!
Ralph Fucetola JD