Genetic Edge Compounds LLC FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

“Milk thistle – used as a natural treatment for liver problems….helps repair liver cells damaged by alcohol and other toxic substances.”

“Alpha Lipoic Acid…may also be helpful in certain liver diseases.”

“Chinese skullcap…helpful in preventing heart disease and limiting the damage to the heart following a heart attack. It is also used to combat high cholesterol, triglycerides, and high blood pressure.”

Potential Health Risks

“[D]ecreases the amount of testosterone in men putting them at risk for many unwanted side effects such as depression… “

Ensure that a qualified person will investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of 21 CFR 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury [21 CFR 111.560(a)(2)].

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 [21 CFR 111.83(b)(3)].