Quicksilver Scientific manufactures a number of dietary supplements based on liposomal delivery. The warning letter, which was posted on FDA’s website yesterday and was dated Oct. 13, took the Louisville, CO- based manufacturer to task over a host of alleged disease claims that were made within blog posts. The blog posts have since been removed.
Among the alleged disease claims in the warning letter were mentions such as:
- “[S]tudy on CoQ10 . . . found a 44% reduction in death from heart disease in heart failure patients supplemented with CoQ10, and a 42% reduction in death from any cause.”
- “[D]irectly fight pathogens and bacteria. If there is one nutrient that is essential for mitochondria, it is CoQ10.”
- Also about CoQ10: “It has also been shown to protect the liver from alcohol-related damage.”
- “Monolaurin . . . has immune modulating properties and antimicrobial effects against a variety of bacteria and viruses.”
Keep sales and education separate
Attorney Marc Ullman, of counsel with the firm 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. That’s especially true when those statements are housed within a more conversational form such as a blog post.
“When you start talking about how something is going to ‘fight pathogens,’ FDA is always going to object. But for some of these statements, including the word ‘occasional’ might cure the issue,” Ullman told NutraIngredients-USA.
“When you start talking about something like insomnia, that’s another area where you have to be very careful with your word choice. Including or excluding a particular word might make you cross over from an acknowledged structure/function claim into an area where FDA might call it a disease claim,” he aded.
Ullman said that as the blog posts have been removed — the kind of quick reaction to an FDA letter he’d expect from a company of Quicksilver’s stature — it’s impossible to tell now if there was a close link from the statements FDA found impermissible to places where consumers could purchase the products. Such a direct linkage 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.
Hangover from hangover claims
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 seen as disease treatment claims or if this is a case of regulatory overreach will be the topic of a future article on NutraIngredients-USA.