Marketers used to playing a little fast and loose with their product language are going to have to be more creative in getting their message across, as the Obama Administration’s FDA is aggressively defining what constitutes a drug claim.
In a warning letter dated July 22, FDA informed Herbal Remedies that its Sambucus Immune System Formula with Elderberry and Echinacea is being sold as a product "intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people."
Now, it's no surprise that natural-health companies are capitalising on the swine flu outbreak to hock their wares. What's different is the Herbal Remedies product advocates no such thing.
"This letter is particularly interesting as the advertising cited does not mention H1N1 or swine flu," noted industry attorney Marc Ullman, a partner in New York City-based Ullman, Shapiro & Ullman.
The FDA cited a Herbal Remedies' website claim that reads: "Sambucol Immune System Elderberry Formula supports your natural defenses against the Flu, and Colds, and is especially popular during the winter season."
"FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA," wrote Roberta F Wagner, director of the Office of Compliance at the Center for Food Safety and Applied Nutrition in the warning letter. "Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared, and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act.
Once the violative claims and/or products have been removed from a company's website, and these corrective actions have been confirmed by the FDA, the published list will be updated to indicate that companies have taken appropriate corrective action.
FDA is giving companies all of 48 hours to comply. Failure to do so could mean product seizures or injunctions.
There are currently 126 entries on the list of products illegally marketed as targeting the H1N1 "swine flu" virus.
As the immune-health category expands, from supplements to yoghurts to drinks, it's marketer beware. "Some of the dry cereals are also starting to call out immune benefits on their packaging," said Cheryl Sturm, director of marketing for Embria Health Sciences, supplier of EpiCor brand immunity-balancing ingredient. "There are actually a number of categories starting to focus more heavily on immunity."