FDA insists H1N1 Warning Letters stop false claims

By Mike Stones

- Last updated on GMT

Related tags: Influenza, Food and drug administration

The Food and Drug Administration has rejected suggestions that its enforcement action against companies which make false H1N1 claims for their health supplements relies too heavily on warning letters and fails to deter other companies from similar fraud.

Last month, food lawyer Marc Ullman, a partner with New York legal firm Ullman, Sharpiro & Ullman, told NutraIngredientsUSA.com that the administration gave too much importance to warning letters and not enough to other forms of enforcement action. “It is laudable sending out warning letters against companies making this kind of fragrantly illegal claim but the apparent absence of follow up is baffling​,” he said.

Criminal prosecution

But a FDA spokesman told this website that: “FDA will consider whatever means are necessary to stop the marketing of fraudulent H1N1 flu products and will hold those who are responsible for doing so, accountable. This could include civil (seizure, injunction) or criminal (prosecution) enforcement actions as appropriate​.”

Warning Letters are FDA's main means of achieving voluntary compliance because they allow the recipient the opportunity to take corrective action, he added.

More than 80 per cent of the recipients of the Warning Letters have voluntarily removed the objectionable claims or products from the websites, said the administration. Firms that have not complied with Warning Letters are subject to possible judicial and/or criminal action.

Follow-up investigations in support of civil enforcement action have been taken against several sites that have not removed objectionable products or claims. Also several websites that have not taken corrective action have been referred to the Office of Criminal Investigations (OCI) for further follow-up.

The spokesman said the FDA has sent Internet Service Providers (ISPs) copies of Warning Letters which lead the providers to decide that the websites and/or domain names were in violation of laws and agreements, leading to the suspension of the website and/or domain name.

Dietary supplements

In total, the administration has issued more than 80 Warning Letters by e-mail to owners of web sites offering over 150 products for sale that claim to diagnose, cure, prevent or treat H1N1 swine flu. The letters cover products claiming to be dietary supplements, as well as products purporting to be drugs, devices or vaccines.

Meanwhile, the FDA issued a total of 73 warning letters last year compared with 44 in 2008; most of which concerned internet cancer claims.

In a guest article written for this site last month, Washington DC-based advertising and labeling attorney, Ivan Wasserman, commented: “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​.”

Last year the new FDA leadership pledged to step-up enforcement compared with the previous administration.

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

Related topics: Regulation, Product claims

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