By Patricia Hammond, J.D.
A dietary supplement distributor, Regeneca Worldwide, was blocked from selling its products by a federal district court in California because the products were found to contain 3-dimethylamylamine (DMAA) and other harmful ingredients. The court issued a permanent injunction, citing the company’s unlawful distribution of unapproved new drugs and adulterated and misbranded dietary supplements (U.S. v. Vivaceuticals, Inc., February 8, 2017, Staton, J.).
DMAA. DMAA, an amphetamine derivative, has been widely used in sports supplements and is described often as a "natural" stimulant, a body-building aid, an athletic performance enhancer, and a weight-loss aid. There are no recognized Medical uses of DMAA currently. DMAA can elevate blood pressure and lead to cardiovascular, neurological, and psychological problems and conditions.
Warning letter. Previously, the Food and Drug Administration (FDA) sent Regeneca a warning letter in August 2012 citing the use of DMAA, stating that if a dietary supplement contains a new dietary ingredient (one not marketed in the U.S. before October 15, 1994), it shall be deemed adulterated unless (1) the ingredient has been presented in the food supply as an article used for food in a form in which the food has not been chemically altered; or (2) there is a history of use or other evidence of safety establishing that the ingredient, when used under conditions recommended or suggested in the labeling of the supplement, will reasonably be expected to be safe, and the manufacturer or distributer of the product provides the FDA with information that is the basis for these findings. The FDA stated that there is no information demonstrating that DMAA was lawfully marketed as a dietary ingredient before October 15, 1994, and that it knows of no evidence that would establish the safety of the product. The FDA requested that Regeneca correct the violations or face enforcement action.
Consent decree. The consent decree mandates the destruction of all remaining products and prohibits Regeneca from marketing unapproved new drugs and adulterated and misbranded dietary supplements. Before resuming operations, the court required Regeneca to hire a good manufacturing practice and labeling expert, without personal or financial ties to the company or the families of the owners and who is qualified to inspect the facility of the company, to determine whether methods, processes, and controls are operated in conformity with the FDA’s requirements—adequate to ensure that none of the dietary supplements distributed by the company contains an unsafe food additive, and adequate to ensure that none of the products contain labeling stating "approved as a new drug" or "authorized for investigation as a new drug."
The consent decree also requires Regeneca to implement good manufacturing practice and labeling requirements and receive written permission from the FDA to resume operations. Once operations resume, the court requires an independent auditor to make inspections at least once every six months for a period of three years, and then once every year thereafter. The first audit must not occur more than six months after the company receives permission to resume operations.
The case is No. 8:15-cv-01893-JLS-KES.
Attorneys: Monica Christine Groat, U.S. Department of Justice, for the United States of America. Dirk Odell Julander (Julander Brown & Bollard LLP) for VivaCeuticals, Inc. d/b/a Regeneca WorldWide.
Companies: VivaCeuticals, Inc. d/b/a Regeneca WorldWide; United States of America
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