FDA Compliance, What Not to Do

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Every Tuesday morning at about 9:30 Eastern time, the U.S. Food and Drug Administration (FDA) posts the most recent Warning Letters on its Web site.

An FDA Warning Letter notifies regulated industry about violations that the agency had documented during an inspection or investigation. As stated in the Agency's Regulatory Procedures Manual, "Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act."

The Warning Letters highlight those enforcement issues that the agency deems most important.  Regulated industry—and this includes manufacturers, distributors and retailers (particularly those with own label brands)—should make full use of this valuable resource by reviewing letters relevant to the natural products industry on a weekly basis.

If you do so, these are the issues that you will see most often and should be most concerned about:

current Good Manufacturing Practices

The dietary supplement GMPs were issued over seven years ago and FDA is actively inspecting and enforcing.  An inspected manufacturer or distributor may receive a Form 483 (Report of Inspectional Observations) after an inspection.  If the 483 is not satisfactorily addressed, a Warning Letter is sure to follow.

Generally, the most serious GMP issues are highlighted in Warning Letters.  Through Warning Letters, regulated industry has learned quite a bit about what the agency expects in terms of GMP compliance, both for manufacturers and distributors, particularly so-called "own label" distributors.

An "own label distributor" is a company that does not manufacturer, but distributes products under its own brand name manufactured by a contract manufacturer.  This would seem to logically include retailer store brands.  In terms of an own label distributor's GMP responsibilities, in Warning Letters FDA has stated:

As an own-label distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of such dietary supplements. You have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.

http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm307669.htm

As an own-label distributor that contracts with other firms to manufacture products that your firm releases for distribution under its own name, you have ultimate responsibility for the products that you introduce or deliver for introduction into interstate commerce. You are responsible for ensuring that your firm and products are in compliance with all requirements of the Act and pertinent FDA regulations, such as the current good manufacturing practice regulations for foods (21 CFR Part 110) and the food additive regulations (21 CFR Part 170). [This was for conventional foods, but the same theory applies].

http://www.fda.gov/iceci/enforcementactions/warningletters/2011/ucm294506.htm

In reviewing other companies'  Warning Letters, ask yourself, if an FDA investigator was sitting in my office, would my company be able to satisfactorily address every GMP issue raised?  If not, then you know that your company possibly has serious GMP issues that  you will want to address before the arrival of that FDA Investigator.

Adulteration: Products with Active Pharmaceutical Ingredients

There has been a constant stream of Warning Letters concerning weight loss products containing active ingredients such as sibutramine, body-building products containing anabolic steroids or steroid analogs and sexual enhancement products that contain phosphodiesterase (PDE) inhibitors, such as sildenafil or an analog.  Some recent FDA Warning Letter examples:

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm419450.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm401614.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm352042.htm

The presence of these adulterants are now well-known and FDA is actively enforcing.  There are also very significant safety concerns.  If you manufacture or market these products, or as a retailer, choose to place these products on your store shelves or Internet Web site, the FDA Warning Letters are just that — a warning.  Take the necessary steps to ensure that your company does not manufacture or distribute any adulterated products that contain active pharmaceutical ingredients.

Misbranding: "Disease" or "Drug" Claims

Almost every FDA Warning Letter concerning dietary supplements includes a discussion of disease or drug claims.  Under DSHEA, dietary supplements may include structure/function claims on labels and labeling, so long as the claims are adequately substantiated, the company submits a 30-day notification letter to FDA  and includes a disclaimer: "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."

Despite the disclaimer, way too often, companies include claims that evidence the intent to market dietary supplements  "to  diagnose, treat, cure, or prevent any disease."  One thing I have seen is that companies will spend a great deal of time and effort on label claims and somehow still view the Internet as the "Wild West", where compliance is simply not that big of a concern. 

In reviewing Warning Letters, however, it is obvious that the vast majority of the cited claims come from Internet Web sites.  Non-compliant Web sites are there for the world to see, including FDA investigators who can review them at any time.  In addition, FDA has made it very clear that company-controlled social media sites such as Facebook, Twitter, Pinterest and YouTube must be kept compliant (free of disease claims).  For example:

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm415809.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm416023.htm

http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm419451.htm

If you care about compliance, make certain to carefully review FDA Warning Letters to see how and what claims are of concern and why they have been cited by the Agency.  Then make certain that such issues do not appear on your company's labels, labeling, Internet websites or store shelves. WF

 

 

 

Steven Shapiro is a partner in New York based Ullman, Shapiro & Ullman.  His practice focuses on the dietary supplement/natural products industry with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.

 

Published on WholeFoods Magazine Online, 10/30/14