2009 review: FDA warning letters clampdown

In 2008, the Food and Drug Administration (FDA) issued 44 warning letters with internet cancer claims being the primary target. In 2009, the agency upped the ante, issuing 73 letters, half of which targeted swine flu (H1N1) products. Washington DC-based advertising and labeling attorney, Ivan Wasserman, looks back on a busy year for the FDA.

Our review identified 73 warning letters involving dietary supplements issued by FDA in 2009.

TARGET OF LETTER		NUMBER OF LETTERS
'Drug/Disease' claims		72
H1N1claims		37
Heart Disease/cardiovascular claims		11
Diabetes claims		8
Cold/Flu (other than H1N1) Claims		8
Cancer claims		8
Other “drug/disease” claims		20
Claims made on websites		72
Claims made in metatags		6
Claims made on labels and labeling		12
Claims concerning “FDA approval”		1
Claims made in broadcast or print advertising		1
Tainted products		1
GMP violations		0

The 73 Warning letters issued in 2009 compare to 44 issued in 2008 – a 66 percent increase. When new leadership came to FDA in 2009, they came with a promise to step-up enforcement compared to the previous administration.

While some of the increase in warning letters in 2009 can be attributed to the prevalence of products claiming to treat the 2009 H1N1 flu virus, it certainly appears at least that the ‘new’ FDA will be more vigilant in policing the dietary supplement industry.

Web focus

Out of 73 Warning letters, 72 involved claims made on web sites. That’s consistent with 2008. As a general rule, FDA can consider any statement or claim that appears on dietary supplement web pages to be a labeling claim for the product. This can include claims made in consumer testimonials, metatags, and in third party literature excerpts and citations.

2009 – all bout H1N1

In terms of product categories, in 2009, the FDA’s main target was dietary supplements that made any type of H1N1 claim. That should be no surprise, as H1N1 generally, and targeting illegal H1N1 products specifically, was certainly a high-profile priority for FDA in 2009.

In addition to warning letters, FDA created dedicated sections of its web site and issued press releases in an effort to inform the public about these products. H1N1 could remain a priority for FDA in 2010, depending on the prevalence of the virus and the likely related prevalence of products claiming to treat or prevent it.

What is somewhat surprising is the dramatic drop in letters targeting cancer-related products. In 2008, 36 of the 44 letters (82 percent) involved, at least in part, cancer-related claims, compared to only eight out of 73 in 2009 (11 percent). Even as a percentage of non-H1N1 letters, cancer-related letters only accounted for 22 percent (8/36).

One possible enforcement trend evidenced by FDA’s 2009 warning letters is the number of letters targeting two categories of products that are not dietary supplements but, like supplements, are generally marketed without FDA approval: homeopathic drug products and medical foods.

What is a warning letter?

The agency sends warning letters to manufacturers or marketers to inform them of violations of FDA laws and regulations. FDA may observe violations during an inspection of manufacturing or other facilities. The agency can also review product labeling and, importantly, claims made on websites.

One area of focus for dietary supplements is the distinction between permissible ‘structure/function’ claims and unlawful ‘disease’ or ‘drug’ claims - i.e. claims that state or imply the product will treat, cure, or prevent a disease.

Ivan Wasserman is a partner at Manatt Phelps & Phillips in Washington, DC. He specializes in advertising and labeling issues for the food and dietary supplement sectors.