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:
24 Arthritis
24 Inflammation
22 Antimicrobial
22 Cancer
21 Diabetes
18 Blood Pressure
16 Cholesterol
16 Pain
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.
Ralph Fucetola JD
Citation: http://dietarysupplementexperts.com/fda-warning-letters-2015-summary/