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Regulatory Focus™ > News Articles > In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

In Midst of Crackdown, New Batch of FDA, FTC Warning Letters Target Unapproved Flu Products

Posted 15 February 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a bevy of new warning letters all aimed at "unapproved flu products," part of a recent crackdown by the agency on products it deems to be either ineffective or potentially dangerous.


The 2012/2013 flu season has been a particularly strong one in the US, and high public demand for flu vaccinations has put FDA on edge, and for good reason: The combination of drug shortages and public concern is a potent recipe for fraudulent or misbranded products.

The US hasn't dealt with widespread shortages of either the flu vaccine or approved flu treatments, such as Tamiflu, but both have been in short supply in certain locations, referred to as a "spot shortage." While these are more easily resolved than more conventional drug shortages, the likes of which FDA is dealing with for many sterile injectable drugs, the shortages have nevertheless opened marketing opportunities for some companies peddling non-approved products.

That trend has already led to two warning letters in 2012, both of which were highly unusual by FDA's standards.

In the first letter, sent to Cold Defense LLC, FDA joined up with the Federal Trade Commission (FTC)-an extremely rare occurrence-to call on the company to stop marketing its "GermBullet" product, which the company was allegedly marketing as a "safe, effective" treatment against the influenza virus. The warning letter was also unusual in its publication speed. Many warning letters cite events that happened months, even years ago. The warning letter, released 24 January, references events that occurred on 15 January-an incredibly fast turnaround for an agency that must clear warning letters through legal staff.

In the second, sent to an alleged "diploma mill" by the name of University of Berkley, FDA said the company was hosting on its website an unapproved homeopathic product that claimed to be able to immunize patients against the flu virus.

Both webpages in question have since been scrubbed clear of the offending remarks.

New Actions

But FDA appears to only be getting started on its crackdown. On 14 February 2013, it published another eight warning letters sent to companies regarding "unapproved products related to the 2012/2013 flu season." The simultaneous release of so many warning letters usually indicates its awareness of an ongoing and larger problem. Similar campaigns in the past have been conducted against foreign firms with unregistered facilities doing business in the US and so-called "Brazilian blowout" hair treatments.

At least three of the newly-posted warning letters were joint FDA-FTC letters, all sent to online purveyors of vitamin supplement products marketed as offering protection against the flu virus. Several touted the ability of the products to boost the immune system, saying those benefits would be of specific assistance in warding off the flu or lessening its effects.

The remaining five letters were sent exclusively by FDA, and involve more serious claims. In one instance, a Panamanian distributor was marketing "generic Tamiflu"-odd because Tamiflu is not yet off-patent, and is a prescription medication not available for sale directly to the public. Regardless of whether the product being sold is genuine, it would violate federal law because it is unapproved as a generic drug, FDA explained.

Three other distributors were also found to be marketing either "generic" Tamiflu or a "Tamiflu 75mg Gel Tablet" product, all of which FDA said were both unapproved by FDA and misbranded under federal law. (1) (2) (3)

Twitter and Facebook: FDA's Watching

Still another manufacturer, US-based Oasis Consumer Healthcare, was alleged to have misbranded its Halo "germ defense" product as conveying protection against cold viruses, specifically including the flu. Notably, FDA cited two of the firm's Twitter postings and one Facebook posting to help make its case that the product was misbranded under federal law. Citing social media posts, while not unprecedented, is relatively rare for FDA.

As of the time of this article's posting, those Twitter postings were still available online, though the Facebook posting appears to have been removed. (1) (2)

Also of interest: FDA's cites the tweet using the website's URL that is specifically generated for mobile devices (https://mobile.twitter.com/halogermdefense), indicating that its inspectors may be investigating those products from their own mobile phones, or while on the road conducting other inspections.

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