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Regulatory News | 27 October 2014 | By Alexander Gaffney, RAC
Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation.
But one company, cited by FDA in September 2014 Warning Letter alleging that it improperly marketed a product to treat Ebola, is fighting back in an unusual manner: through FDA's Citizen Petition Process.
Warning Letters are used by FDA to warn companies that regulators consider their actions to be contrary to either regulations or the law, and that a failure to take corrective actions may lead to more serious enforcement actions or penalties. The letters generally follow an inspection of a company's physical manufacturing operations by FDA employees, but may also follow an inspection of a company's website.
Citizen Petitions, on the other hand, are the public's way of warning FDA—of policies that are outdated, products that should be approved, decisions which should be overturned or a need for additional information. Though the petitions are often used in industry, they are rarely—if ever—used to comment on specific Warning Letters.
But following the release of several Warning Letters in September 2014 to companies allegedly marketing their products as being able to treat the Ebola virus, one company is using the Citizen Petition process to fight back.
In a petition to FDA, Natural Solutions Foundation, a New Jersey-based marketer of dietary products cited in one of the September 2014 Warning Letters, asks the agency to allow it to market its products using FDA's "enforcement discretion" authority. That authority is occasionally used by FDA to allow products which would otherwise not meet federal regulations to remain on the market, such as during a drug shortage or in other public health emergencies.
The agency should use its discretion to allow the "free and open discussion" of the potential utility of the company's Nano Silver product to treat or prevent Ebola, the company said.
FDA's letter said the company's claims that Nano Silver could be used to treat, prevent or inhibit the Ebola virus were a clear violation of the Federal Food, Drug and Cosmetic Act (FD&C Act), which bans the use of such claims for products which are not explicitly approved for that purpose by FDA.
The company has become something of a punching bag for FDA, whose leader, Commissioner Margaret Hamburg has taken to referencing the company's marijuana constituent-infused chocolate bar—also promoted as an Ebola treatment—as a clear sign of quackery. "Note to audience: Do not buy," she told a conference of health industry professionals in October 2014.
Natural Solutions Foundation's petition also contains a copy of its response to FDA's Warning Letter in which it pledges to stop selling the two products referenced in FDA's Warning Letter and alter the marketing of its products. At the time of this article's publication, the company's website still contains numerous references to Ebola.
Tags: Citizen Petition, Warning Letter, Ebola