Rare Multi-Agency Warning Letter Slams Flu Product

The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus.

The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers its enforcement authority to FDA under a memorandum of understanding.

But both agencies might have been eager to exercise their enforcement discretion on the influenza product in light of an unexpectedly strong outbreak of the flu now sweeping across the continental US. Already, 29 states are reporting flu levels to be "high" or "severe," and consumers seeking to get vaccination have resulted in some spot shortages of existing vaccines.

One of FDC's products, GermBullet, is marketed on the company's website as being an inhaler that administers a "botanical formula" offering to reduce "illness-causing bacteria, cold and flu viruses and fungi."

"The new inhaler delivery system gives your body's defenses a higher probability of effectively combating germs, so that you remain healthy," it said. The company further cited testing conducted by an "FDA recognized virology lab" showing the product "has a broad spectrum potential capability to kill illness-causing bacteria, mold, and fungi.

"GermBullet is safe, effective, and proudly made in the USA," it added.

'Misbranded Under the Law'

But FDA and FTC took direct aim at these claims, particularly after the company issued a press release on 15 January 2013 indicating that the product would be useful in protecting patients against the flu epidemic. The claims show the company is marketing the product as a drug in violation of the Federal Food Drug and Cosmetic Act, the two agencies wrote.

Without having received FDA approval, a product cannot market itself for a specific condition or as being safe and effective for a condition. "Your sale of GermBullet without an approved application violates these provisions of the [FD&C] Act," FDA and FTC wrote.

The time between the alleged infraction and the release of the warning letter is also unusually short. Many warning letters-in particular those sent in response to alleged manufacturing infractions-reference activities that occurred months or years ago. The nine-day response time potentially indicates that FDA and FTC are marshaling their resources to go after those allegedly exploiting current disease trends on a more proactive basis.

Some of the claims made on the company's website as also downright false, FDA said. For example, "FDA has not 'recognized' any virology lab that has independently tested your product," they wrote. 

The company was given 15 days to respond. Regulatory Focus has reached out to FDC and will update this space if we receive a response.