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.