FDA and Dietary Supplement Industry Under Scrutiny for Dangerous Ingredients

Dietary supplements are popular among individuals attempting to lose weight or build muscle quickly. However, recent studies and news reports are calling attention to questionable ingredients, underlying health risks, and the Food and Drug Administration’s (FDA) alleged inaction in regulating these products.

Synthetic Amphetamine Discovered in Supplements

Published in the journal Drug Testing and Analysis, the results of a recent study show that certain weight loss supplements contain a synthetic compound called BMPEA (beta-methylphenylethylamine), an amphetamine-like substance that has never been studied in humans and may have the potential to cause heart attack, stroke, or even death.

The trouble with this finding is that the labels on many supplements do not list BMPEA as an ingredient and instead list a shrub called Acacia rigidula (even though some of the supplements don’t have any trace of the plant). Speaking with ABC News, study author Dr. Pieter Cohen of Harvard Medical School noted that BMPEA is not derived from the Acacia rigidula plant and that it is not a regulated drug. The FDA has issued warnings to five companies to stop selling dietary supplements containing BMPEA. Affected products include Fastin-XR, Lipodrene, Sudden Impact, Core Burner and Phoenix Extreme.

Other Supplements in the News: DMBA; Muscle-Building Pills & Powders

Amid growing pressure to crack down on dangerous ingredients, the FDA is also warning companies to stop selling supplements that contain DMBA, also known as 1,3-Dimethylbutylamine, AMP, AMP Citrate and other names, and found in products such as 1ViZN, LLC’s Velocity™. Dr. Cohen published another study last year that pointed to 12 dietary supplements that contained DMBA, which is a stimulant similar to BMPEA and DMAA (1,3-dimethylamylamine), another dangerous substance used in sports supplements, which the FDA has sought to have removed from the market.

Sokolove Law is no longer accepting Dimethylamylamine Cases.

The FDA has also issued a warning about a muscle growth supplement called Tri-Methyl Xtreme, distributed by Extreme Products Group, which, according to the agency, has been linked to severe liver injury. The product claims it contains anabolic steroids. Anabolic steroids may hurt many different organ systems, negatively impact cholesterol levels, and increase risk of heart attack and stroke, among other serious effects.

A Call for Greater Standards in the Supplement Industry

Dietary supplements are not required to undergo the same rigorous testing as drugs and typically do not need approval from the FDA before they are marketed.

The FDA is being called out by U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT), who feel that the organization is not doing enough to protect the public from potentially dangerous supplement ingredients. After learning about the Harvard BMPEA study, the senators sent a letter to the FDA, condemning their “inaction.”

“For too long dietary supplement manufacturers have either failed to list BMPEA on product labels or have listed the stimulant as ‘natural botanical,’ which the Food and Drug Administration’s own scientists have disproved,” wrote the senators.

They went on to say, “FDA should move quickly to conduct a thorough inspection of all dietary supplements containing A. rigidula plant extracts and other BMPEA amphetamine-like substances.”

Dr. Cohen is also unimpressed with the FDA’s inaction. His BMPEA study showed that the FDA has known about BMPEA mislabeling since 2012—but they have chosen to remain silent on the issue until recently. As lawmakers and researchers begin to learn more and see eye-to-eye on this issue, we are hopeful that there will be positive changes to the dietary supplement industry in the near future.

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Sokolove Law Team

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Last modified: March 12, 2020