FDA, FTC Cite Flu Claims in Warning Letters

WASHINGTONIn warning letters submitted to a number of companies after reviewing their websites and other promotional materials, U.S. regulators declared several products are being unlawfully marketed during the flu season.

"The marketing and sale of unapproved or uncleared Flu Virus-related products is a potentially significant threat to the public health," FDA and FTC officials stated in a warning letter to Vitalmax Vitamins. "Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or clearance by FDA, claim to diagnose, mitigate, prevent, treat or cure Flu Virus in people."

FDA warned Vitalmax Vitamins it is marketing a product, BodyGuard, that is intended to treat the Flu Virus but is not approved to do so, constituting a violation of the Federal Food, Drug, and Cosmetic Act.

"We request that you immediately cease marketing unapproved and uncleared products for the diagnosis, mitigation, prevention, treatment, or cure of the Flu Virus," government officials wrote.

Colleen Hager, VP of Operations with Vitalmax Vitamins, said the company is addressing FDA's concerns "by removing the claims noted, all of which were intended to have been removed in mid-January."

Government officials with FDA and FTC also teamed up in warning letter to Kosher Vitamin Express, declaring several products the company offers are not approved to treat the Flu Virus.

FTC informed Kosher Vitamin Express it must "possess competent and reliable scientific evidence" in order to lawfully advertise that a product can treat a human disease.

"More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, consumer testimonials, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act," the letter stated.

Supplementality LLC received a warning letter regarding several products including one called Garlic 90. FDA and FTC officials expressed concerns over such website statements as "[Garlic] is used historically in treating flu ", "Help fight off influenza and other viruses and their symptoms naturally with this selection of herbs and other products" and "Used for colds and flu."  

Generic Tamiflu Warnings

In a warning letter to Sun Drug Store, FDA noted the company offered for sale "Generic Tamiflu". Tamiflu is the proprietary name of an FDA-approved drug (oseltamivir phosphate) that is well known for treating influenza, the letter observed. FDA classified Generic Tamiflu as a new drug. Introduction of the product into interstate commerce violates federal law because no approved applications are in effect for a generic Tamiflu, wrote Howard Sklamberg, Director of FDA's Office of Compliance, Center for Drug Evaluation and Research.

Medsnoscript also received a warning letter from FDA in connection with the sale of Generic Tamiflu. So did Discount Online Pharmacy.

FDA cited similar concerns in a warning letter to Secure Medical Inc. concerning its Tamiflu 75mg Gel Tablet. The product offered for sale is an unapproved drug and it is "misbranded" for a number of reasons, Sklamberg declared.

"Unapproved new drugs from unregulated sources do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether," he wrote.

In another warning letter to Oasis Consumer Healthcare LLC, FDA raised concerns over a product (Halo) that claims to treat or prevent germs. Sklamberg cited statements on its website, information on its Facebook account, claims on its Twitter page and a press release from PR Newswire. "Based on its labeled uses, Halo is a new drug" under federal law "because it is not generally recognized as safe and effective for its labeled uses," Sklamberg wrote.

The companies were given 15 days to respond to the letters, and FDA warned it could take legal action if the violations were not promptly corrected.

Kosher Vitamin Express, Supplementality LLC, Sun Drug Store, Medsnoscript and Oasis Consumer Healthcare, LLC did not respond Thursday to emailed requests for comment on the warning letters. Natural Products Insider was unable to find contact information for Discount Online Pharmacy.