Special focus: Recent FDA warning letters offer important lessons for companies

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Special focus: Recent FDA warning letters offer important lessons for companies

Related tags: Dietary supplement, Food and drug administration

The US Food and Drug Administration has issued some important warning letters in recent weeks. In this special focus, we revisit the lessons for all companies, from website claims, to the obligations of private label distributors.

Last week, we reported on two important letters: A warning letter to Pristine Bay, L.L.C., showed the Agency’s stance on the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’.

Commenting on the letter, Justin Prochnow, shareholder at lawfirm Greenberg Traurig, LLP in Denver, said: “I have previously identified warning letters in which FDA has reiterated the obligations of private label distributors to ensure that the cGMPs are followed, even if the private label distributors do not perform any manufacturing duties.

“While other letters have pointed out the obligations of private label distributors, FDA, in an April 26, 2013 letter to Pristine Bay LLC dba Vianda, goes to greater lengths to emphasize the private label distributors’ obligations.”

To read our full coverage and the reaction to this letter, please click here​.

Website links

The second letter detailed the Agency’s stance on links from company websites to articles with disease claims that cause products to be drugs (FDA), causing the products linked to such articles to be drugs.

The letter to Green Bay, Wisconsin-based EuroPharma Co., Inc. and it’s president, Terry Lemerond, make for “important reading”,​ according to a legal alert from the American Herbal Products Association (AHPA).

“Supplement companies that link to articles or published literature from their website product pages take note: FDA views disease discussions in those articles to cause the products to be considered drugs,” ​stated the AHPA note.

“This warning letter to Europharma sets forth in detail how FDA looks at websites for disease claims.

“This is important reading for all companies linking to disease-discussion articles in their websites.”

To read our full coverage and the reaction to this letter, please click here​.

Website claims

Two letters sent Synticare Corp and Birkdale Medicinals indicated that the regulations governing health claims language don’t apply just to product labels. Websites are fair game, too, and can form easy pickings for regulators.

“Website material is often looked at by FDA as part of a product’s labeling.  From FDA’s perspective it is promotional material and FDA will evaluate it as they would with any piece of promotional material, just as they would if they picked up a pamphlet they picked up on a trade show table,” ​Jason Sapsin, a Denver-based attorney with the Polsinelli law firm, told NutraIngredients-USA.

To read our full coverage of these letters, please click here​.

Facebook, too

Finally, we covered two warning letters from the FDA that should serve as a reminder to supplement makers that the agency is scrutinizing their activities on Facebook and Twitter just as carefully as it is looking at their corporate websites.

In a warning letter to AMARC Enterprises, the FDA said a testamonial posted by a consumer on its Facebook page claiming that its PolyMVA dietary supplement “enabled me to keep cancer at bay without the use of chemo and radiation”​ - was ‘liked’ by the company.

As the posting amounted to an unauthorised drug-claim and AMARC had effectively 'endorsed' it by 'liking' it on its Facebook page, the FDA included this as one of several examples of the company promoting PolyMVA “for conditions that cause the product to be a drug”​ rather than a dietary supplement.  

In a second warning letter sent to M.D.R. Fitness Corp (which you can read here), the FDA noted that typing diseases such as ‘cancer’ or ‘diabetes’ into the search box on its website brought up product lists of dietary supplements.

Because those products are as a result 'associated' with cancer and diabetes in consumers' minds, M.D.R. is "implying that its products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases,"​ argued the FDA.

To read our full coverage of these letters, please click here​. 

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