Carol Bond Health Foods FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

“Vinpocetine has been shown to be particularly effective in treating a wide variety of cerebral circulatory disorders including memory problems, acute stroke and motor disorders. Vinpocetine has been shown to be particularly effective in treating functional symptoms such as confusion, loss of attention, lack of concentration, irritability, vertigo, visual and acoustic alterations, mood changes.”

“Getting enough calcium is one of the best ways to prevent osteoporosis.”

“Magnesium . . . helps regulate blood sugar levels . . . . There is an increased interest in the role of magnesium in preventing and managing disorders such as hypertension, cardiovascular disease, and diabetes.”

Potential Health Risks

“When the liver is under attack from viruses or is weakened by hepatitis, cirrhosis, diabetes or has been abused by alcohol, drug abuse or long-term prescription drug use, the liver has [sic] shown to have low levels of these needed antioxidants found only in ThistleX. ThistleX will restore the levels of the fundamental antioxidants your liver needs to stay healthy."

Regulatory Context

Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)].

Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)].

Be retained for one year past the shelf life date (if shelf life dating is used), or for two years from the date of distribution of the last batch of dietary supplement associated with the reserve sample, for use in appropriate investigations [21 CFR 111.83(b)(3)].