Marc Ullman, a partner with New York legal firm Ullman, Sharpiro & Ullman told NutraIngredientsUSA.com that, although the organization had sent out warning letters to companies which are making fraudulent H1N1 claims, to his knowledge, no follow up action had been taken.
“It is laudable sending out warning letters against company making this kind of fragrantly illegal claim but the apparent absence of follow up is baffling,” he said.
The absence of any apparent deterrent could lead some companies to conclude that the worst that could happen to them if they persist in making dubious claims about their products would be that they would receive a nasty letter from the FDA.
Ullman believed this could result in inappropriate criticism of the supplements industry. “The next time someone from the FDA testifies in Congress, they could say the supplement industry is allegedly irresponsible [in failing to redress the problem of fraudulent H1NI claims for supplement]. The very small number [of companies making inappropriate claims] could have a disproportionately large effect on the perception of the industry.”
Instead of apparently relying on the deterrent effect of letters, FDA should back warning letters with decisive action, said Ullman. “The FDA warning letters require companies to take corrective action within 48 hours. So, [if nothing has changed] after 49 hours, the FDA should act against them.”
Meanwhile, the warning letters, written by Roberta Wagner, director Office of Compliance, Center for Food Safety and Applied Nutrition advise recipients: “You should take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA.”
Recipents are further asked to: Within 48 hours send an email to FDAFLUTASKFORCECFSAN@fda.hhS.gov describing the actions taken or planned to remedy the violation.
If the company fails to take immediate corrective action, FDA warns that its enforcement action may include seizure or injunction for violations of the Federal Food, Drug, and Cosmetic Act (FFDC Act) without further notice.
Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.
Companies and websites which have received a warning letter from FDA concerning their marketing of unapproved, uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act can be found at www.accessdata.fda.gov/scripts/h1n1flu.
No one from the FDA was available for comment before publication.