The Food and Drug Administration sent warning letters to ten companies advertising what the agency termed fake flu cures and treatments.

Many of the recipients – Discount Online Pharmacy, Flu & Cold Defense LLC, Kosher Vitamin Express, Mednoscript, Oasis Consumer Healthcare, LLC, Secure Medical Inc., Sun Drug Store, Supplementality LLC, the University of Berkley, and Vitalmax Vitamins – advertised their products as “generic Tamiflu.”

But the agency has not approved any generic versions of Tamiflu or Relenza, which are the FDA-approved flu treatments.  There are also no over-the-counter drugs approved for flu treatment either.

“These drugs are misbranded in several different ways,” the FDA said in its letter to Discount Online Pharmacy.  “Your website offers prescription drugs for sale without requiring that the drugs be dispensed only upon a prescription from a practitioner licensed by law to administer such drugs.”  In addition, the FDA said, the Web site and promotional labeling for the product “misleads the consumer to believe that the product they are purchasing is an FDA-approved drug product.”

The agency also expressed concern that consumers will take the advertised drugs without the supervision of a healthcare professional and pharmacist. As labeling does not include adequate directions for the intended uses, unsupervised use could lead to potentially dangerous consequences.

“We request that you immediately cease marketing violative drug products to United States consumers,” the agency stated. If the companies failed to act within 15 days, they faced regulatory action.

Some of the letters were co-authored by the Federal Trade Commission.  In a letter to Vitalmax Vitamins, the agencies highlighted several claims for the product “Body Guard,” including: “Boost Your Immune System and Fight Cold and Flu – Naturally!” and “In fact, the healing nutrients in these tiny tablets can help you: Fight colds, infections and respiratory problems; Safeguard you from deadly flu viruses; Relieve you from stuffy noses, chills, hoarseness and other cold symptoms!”

“The marketing and sale of unapproved or uncleared Flu Virus-related products is a potentially significant threat to the public health,” the agencies wrote.  “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.  You should take immediate action to ensure that your firm is not distributing, and does not distribute in the future, products intended to diagnose, mitigate, prevent, treat or cure the Flu Virus that have not been approved or cleared by the FDA.”

Vitalmax also touted “scientific studies” that supported its Body Guard claims.  But the FTC noted that advertisements that a product can “prevent, treat, or cure human disease” are unlawful unless the advertiser can support the claim with competent and reliable scientific evidence, including multiple human clinical studies.  “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 agency cautioned. The company was given 15 days to address its concerns.

To read the warning letter to Discount Online Pharmacy, click here.

To read the warning letter to Vitalmax Vitamins, click here.

Why it matters:  The letters addressed a variety of alleged flu treatments that were delivered in several forms. They included, among others, oral sprays and multiple dietary supplements.  “The FDA will consider whatever means are necessary to stop the marketing of fraudulent flu products to prevent them from proliferating in the marketplace – and will hold those who are responsible for doing so, accountable,” said FDA spokesperson Sarah Clark-Lynn.  “This may include considering civil (seizure, injunction) or criminal (prosecution) enforcement actions as appropriate.”