New FDA Warning Letter Shows Web Content Is Extension of Labeling

New FDA Warning Letter Shows Web Content Is Extension of Labeling

May 13th, 2013 // 9:48 pm @

Latest FDA and cGMP Compliance News

FDA this month issued a warning letter for a drug company – Europharma – that has a website that links to articles that has disease claims, which FDA states causes the products to be considered drugs.

The company is based in Green Bay, WI, and this warning letter makes for very important reading for the pharmaceutical and supplement industry.

The warning letter from FDA shows that supplement and drug firms that have links on their sites to articles need to be careful. FDA is showing that any disease discussions in such linked articles will cause the products to be drugs under the FDA definition.

This warning letter shows how FDA is going to be looking at websites and disease claims.

Interestingly, Europharma confirmed that they got the letter, but they challenged some of the FDA claims.

The argument is that the claims as alleged by FDA were not on their site but in articles they linked to. The articles were differentiated with a disclaimer that indicated that the article was entirely reprinted, it didn’t promote a specific supplement brand, and the article also did not promote a particular supplement company.

Europharma contends that this type of literature is 3rd party complaint literature, according to the definition laid out in Section 5 of the Dietary Supplement Health and Education Act of 1994, or DSHEA. Section 5 exempts qualifying literature from the labeling definition when the material is used related to dietary supplement sales.

The firm noted that the articles do reference formulas with the same ingredients and amounts, but Europharma believes that the same is not going against DSHEA mandates.

Europharma has stated that it is preparing a detailed response to FDA on this matter, but has taken off all links to the literature until the matter is settled. We’ll see what happens when the company makes its full response.

Note that generally, FDA seems to think of ‘labeling’ as extending across many types of content sources – labels, brochures, social media and websites.

For much more about the latest warning letter and 483 trends based upon 2012 data, consider our May 29 Webinar.


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