The U.S. Food and Drug Administration, or FDA, has made public its March 09, 2018 warning letter to Daron Mettlen and his supplement company, Carol Bond Health Foods, for hawking “new drugs” as well as “adulterated” and “misbranded” herbal supplements.
From the letter we learn that Carol Bond Health Foods was the focus of a multi-day inspection back in September. While there, inspectors say they documented multiple instances of “significant violations” of FDA regulations for anyone distributing dietary supplements.
Inspectors also took a look at various product labels and paid a visit to the company’s website. This allowed them to identify examples of products that were formally deemed “unapproved new drugs” and supplements that are “misbranded” or adulterated.
Supplements Being Marketed As Drugs
Many of the allegations FDA makes about Carol Bond involve dietary “natural” supplements being peddled for specific medical purposes. The company’s ThistleX product, for example, was dinged for its brag about being a “quadruple antioxidant” useful for liver damage caused by hepatitis, cancer, diabetes or substance abuse:
Another product that got the company in hot water was its Vinpocetine supplement, with its verbiage about memory issues, stroke, vertigo and more:
The company’s Dolomite supplement is supposed to help prevent osteoporosis and manage high blood pressure, diabetes and heart disease:
In all, the agency says it found 5 products being sold for the treatment of medical conditions. But, of course, none of them has ever been officially recognized as safe or effective for any of the mentioned conditions. That, says FDA, means they are no longer supplements but are now legally considered new drugs.
Some of the products are also “misbranded” because they’re hawked for medical conditions the average person simply cannot safely self-diagnose or self-treat without a physician’s guidance.
Carol Bond & “Adulterated” Supplements
An unspecified number of supplements labeled for Carol Bond Health Foods were found to be “adulterated”, as well because the company failed to perform any quality control checks on supplements labeled under the Carol Bond name and had no formal procedures in place to do so. As a supplement distributor, says FDA, Carol Bond Health Foods has a legal obligation to make sure its supplements are safe and accurately labeled, whether the company actually makes them or not.
From the FDA’s warning letter we learn that the company did respond to concerns shortly after the inspection but FDA says the response is “inadequate” because the company failed to fully comply. An example of that failure is the company’s refusal to collect and hold product samples.
The FDA’s warning letter to Carol Bond Health Foods is lengthy but not intended as a fully inclusive listing of all the company’s potential violations. The company was given the standard 15 working days to find and address its problems and then respond. As you can see from some of the screengrabs we took for this article, Carol Bond has so far refused to remove some of its alleged illegal sales spiel.
Categories: FDA Warning Letters