Mislabeled Performance Enhancing Supplements May Contain FDA-Banned Drugs

Supplements to boost energy and strength may not accurately list the products' ingredients on the label and could contain potentially harmful drugs prohibited by the FDA.

In new research published on July 17 in JAMA Network Open, scientists analyzed 57 dietary supplements marketed to increase energy or build muscle to determine if they contained five popular botanical ingredients promoted as having stimulant or anabolic effects.

These ingredients include:

• R vomitoria: a botanical thought to boost male sexual performance.
• Methylliberine: a caffeine metabolite found in small amounts in coffee beans.
• Turkesterone: a hormonal steroid found in plants.
• Halostachine: a plant extract that may help burn fat.
• Octopamine: an organic chemical used to increase athletic performance.

The researchers also examined the supplements to see if they contained any FDA-prohibited ingredients.

Of the 57 products analyzed, 13 listed R vomitoria, 21 listed methylliberine, eight listed turkesterone, seven listed halostachine, and eight listed octopamine on the label.

However, the scientists found that 23 of these products did not contain the listed ingredients in detectable amounts. Furthermore, products that did include the ingredient had quantities ranging from 0.02% to 334% of what the label indicated.

What's more, only six products actually contained similar quantities as listed on the label.

Even more concerning, the team discovered that seven of the 57 products tested contained ingredients banned by the FDA. Specifically, they found four synthetic simulants, including 1,4-dimethylamylamine, deterenol, octodrine, and oxilofrine. They also detected a discontinued nasal decongestant called omberacetam.

Moreover, six of these products contained one prohibited ingredient, and one supplement had four of the banned compounds.

Overall, 89% of the performance-enhancing dietary supplement labels did not accurately disclose the ingredients in the product and12% contained FDA-prohibited ingredients.

Though the scientists only analyzed one sample from each supplement and only included those that listed the five popular ingredients on the label, they suggest that healthcare providers should advise consumers that supplements promoted to provide stimulant or anabolic effects might not be labeled correctly and may contain potentially harmful FDA-prohibited drugs.

What are the banned drugs found in these supplements?

According to the study, omberacetam is a drug available in Russia, and octodrine, oxilofrine, and deterenol were formally available in Europe. However, 1,4-dimethylamylamine has never been approved for use in any country.

Omberacetam is a nootropic similar to piracetam, a medication used in other countries to treat traumatic brain injury (TBI) or cognitive issues. It is not approved in the United States and can cause agitation, anxiety, and insomnia.

Octodrine is a nasal decongestant developed over 80 years ago but has been discontinued. The drug may cause high blood pressure and increased body temperature.

Oxilofrine is a drug that stimulates the heart and increases blood pressure. It is not approved in the U.S. and has been linked to vomiting, agitation, and severe events like cardiac arrest.

Deterenol is a synthetic stimulant not approved for use in the U.S. in humans. People taking supplements that contain this ingredient have reported nausea, vomiting, sweating, and agitation. Reports of chest pain, palpitations, and cardiac arrest have also occurred.

1,4-dimethylamylamine is an amphetamine-like drug that can cause adverse events such as shortness of breath or heart attack.

The FDA does not require pre-approval of supplements before manufacturers market their products. Instead, the agency monitors supplements after they are sold and used by consumers.

Previously, the FDA issued a warning letter to consumers about a potentially dangerous ingredient called SARMs that some manufacturers included in their muscle-boosting supplements. The agency also issued warning letters to companies distributing these products.

In addition, the FDA recently alerted consumers about two weight loss supplements that contained potentially harmful hidden ingredients.

Because they are more likely to contain hidden compounds, the agency says consumers should be careful when purchasing supplement products marketed for weight loss, sexual enhancement, or building muscle.