FDA blames Quicksilver Scientific for disease claims in blog posts

Quicksilver Scientific manufactures a number of dietary supplements based on liposomal administration. The warning letter, which was posted to the FDA’s website yesterday and dated Oct. 13, blamed the Louisville, CO-based manufacturer for a slew of alleged illness claims that were made in articles blog. Blog posts have since been deleted.

Among the alleged illness claims in the warning letterwere statements such as:

• “[S]study on CoQ10. . . found a 44% reduction in heart disease deaths in heart failure patients supplemented with CoQ10, and a 42% reduction in all-cause deaths.
• “[D]directly fight pathogens and bacteria. If there is one essential nutrient for the mitochondria, it is CoQ10. “
• Also on CoQ10: “It has also been shown to protect the liver from alcohol damage. “
• “Monolaurin. . . possesses immune modulating properties and antimicrobial effects against a variety of bacteria and viruses.

Separate sales and education

Lawyer Marc Ullman, legal advisor to Rivkin Radler, said talking about the effects of ingredients, even when those effects might be well supported by scientific evidence, is as much art as it is science. This is especially true when these statements are hosted in a more conversational form such as a blog post.

“When you start talking about how something is going to ‘fight the pathogens’, the FDA will always oppose it. But for some of these statements, including the word ‘casual’ might solve the problem, ‘Ullman told NutraIngredients-USA.

“When you start talking about something like insomnia, this is another area where you have to be very careful in your choice of words. Including or excluding a particular word can take you from a recognized structure / function claim to an area where the FDA might call it a disease claim, ”he added.

Ullman said that since the blog posts have been removed – the kind of quick reaction to an FDA letter he would expect from a company of Quicksilver’s stature – it’s impossible to say now. ‘There was a strong connection between the statements that the FDA found inadmissible where consumers could purchase the products. Such a direct link is a red flag for the agency, he said.

“The lesson here is to keep your products away from your consumer education – period.”Ullman said.

Quicksilver Scientific did not respond to a request for comment in time for the publication of this article.

The hangover hangover claims

The FDA had also noted that some of the blog posts related to hangover claims, an area of ​​increasing attention for the agency. Whether hangover claims are properly considered disease treatment claims or whether it is a case of regulatory overshoot will be the subject of a future article on NutraIngredients-USA.