FDA raps probiotic swine flu supplements for false claims
The action follows an earlier statement of intent from the FDA that it would take harsh action against companies that attempted to profit from the Bird Flu crisis that has been named as a public health emergency by the Secretary of Health and Human Services, Kathleen Sebelius.
The World Health Organization estimates 700 people have died as a result of the virus.
The FDA gave Master Supplements 48 hours to send it an email detailing what actions it would take to alter messaging for probiotic supplements on its websites: www.acidophilus-immune-health.com and http://www.master-supplements.com.
FDA inspectors determined that the websites promoted a product, Theralac, that marketed products, “intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people”.
“We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus,” FDA wrote to the company.
It said the marketing breached the Federal Food, Drug, and Cosmetic Act (FFDC Act).
The offending claims included: "The saying goes 'an ounce of prevention is worth a pound of the cure'. Probiotics such as Theralac are a very affordable 'ounce of prevention'. An up-regulated immune system is a healthy immune system. Order Theralac now.... Get one bottle to take ongoing and one to keep on hand if Swine Flu turns pandemic."
Another claim referenced a doctor who placed, “emphasis on supplements such as PROBIOTICS that enhance the immune system.”
FDA noted that while certain products could gain special dispensation to treat swine flu, as requested by the US Centers for Disease Control and Prevention, this was not the case with Theralac.
“The marketing and sale of unapproved or uncleared H1N1 Flu Virus related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health,” FDA said.
“We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act.”
Potential FDA actions include seizure and injunction, or prosecution by the FDA’s Office of Criminal Investigations.
The FDA has warned customers to avoid non-approved products.
