FDA Highlights Concussion Warning Letter

WASHINGTONFDA announced warning letters to companies marketing neuroprotection and concussion recovery products as supplements, advising them the agency considers the products new drugs because they are claimed to treat neurological disorders. The move comes on the heels of study results published in the journal Neurology on Sept. 5 showing death from neurodegenerative causes is three-times higher among former professional football players. The results indicated former NFL (National Football League) players are prone to development of Alzheimer disease (AD), Parkinson disease, and amyotrophic lateral sclerosis (ALS), details picked up by many major media outlets.

In the letter to PruTect Rx, of Highlands Ranch, Colo., warned the company's NeuroPruTect Concussion Response Formula triggered new drug status by claiming, on its website, to reduce "cognitive decline, including Alzheimer's. NeuroPruTect also helps prevent nerve damage and post-concussion syndrome in all athletes."  The company's Omega3PruTect was noted for claiming to "reduce mood disorders, depression, and even memory loss by reducing inflammation with docosahexaenoic acid (DHA) found in Omega-3. OsteoPruTect and VitaminD3PruTect  were also cited for preventing and/or lowering the risk of osteoporosis/fractures and cancer/multiple sclerosis, respectively.

The letter to Trinity Sports Group Inc., of Plano, Texas, detailed disease/condition claims made for its Neuro-Impact product, including improved concussion recovery and mild traumatic brain injuries (MTBIs). The claims were made on the company website an included statements from  sports celebrity endorsers.

FDA stressed to both companies that such disease and condition claims make these products new unapproved drugs, not dietary supplement. as such, the products are being illegally marketed int he United States without FDA approval.

 The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell, said Dara A. Corrigan, associate commissioner for regulatory affairs at FDA. Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.

INSIDER's Take:

The claims made on website marketing these products are clearly render these products as unapproved drugs, but it is interesting the agency issued a special press release about the warning letters. It is possible FDA wanted to capitalize on the  current attention being paid to the NFL brain trauma and death study, as well as the beginning of the NFL regular season, which started this week.

There may be some promise in the use of omega-3s/DHA for brain traumaAdina Michael-Titus, Barts and London School of Medicine, works with DHA in acute neurotrauma patients (see: Top Trends from GOED Exchange 2012 for more information)the point of these and other similar warning letters is that companies can't claim such benefits without FDA approvals. For the other products, claiming prevention or lowered risk of any disease such as Alzheimer's and Parkinson's is sure to draw the agency's attention. By now, companies marketed dietary supplements should be well aware of the regulations and enforcement of claims made not just on product labels and literature, but also on websites and including endorsers.

For more information on the regulation of endorsements, check out " Endorsements and testimonials: What Companies Need to Know ," by Justin Prochnow, attorney with Greenberg Traurig LLP.