Regeneca Receives FDA Warning Letter on DMAA

Regeneca Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) informing the company that its dietary supplement containing DMAA (1,3-dimethylamylamine) cannot be marketed legally in the United States without submitting it for new dietary ingredient (NDI) notification.

An NDI shows the ingredient’s history of use along with evidence establishing that the ingredient is expected to be safe when used according to the recommendation.

The FDA’s letter says that Regeneca’s product RegeneSlim contains DMAA, which is known to narrow blood vessels and arteries and increase cardiovascular resistance that may cause increased blood pressure resulting in heart disease. DMAA is also known to cause cardiovascular events due to the high blood pressure, which can range from shortness of breath to tightening of the chest or heart attack.

Meanwhile, the FDA states that there is no evidence that shows that DMAA can be expected to be safe as a dietary drug ingredient.

The letter warned the company to immediately stop the distribution of RegeneSlim, or the FDA would take enforcement actions such as seizing the products and filing an injunction.

If you or someone you know has been harmed by a dangerous drug, contact Sokolove Law for free legal consultation and to find out if a dangerous drugs lawyer may be able to help you.

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