While FDA remains embroiled in a court fight with Hi-Tech Pharmaceuticals over the regulatory status of DMAA (1, 3-dimethylamylamine) dietary supplements, a federal judge in the Central District of California has issued a permanent injunction to dietary supplement distributor VivaCeuticals (dba Regeneca Worldwide) and its owner, Matthew Nicosia, prohibiting the sale of products adulterated with DMAA and other unsafe, unapproved drugs— phosphodiesterase type-5 (PDE-5) inhibitor such as sildenafil, tadalafil, vardenafil and analogs.
The company had reached an agreement with the Department of Justice in the beginning of 2017, but the deal was awaiting federal court approval.
“Consumers have a right to expect safe dietary supplements," said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs, in a press release. “When a company continues to defraud and deceive consumers, risking public health, we will take action to protect the American public."
The consent decree, signed on Feb. 8 by U.S. District Judge Josephine L. Staton, not only halts the flow of adulterated and misbranded dietary supplements through Regeneca, but it also outlines numerous requirements the company must meet before it can resume business. Regeneca agreed to the injunction without accepting or denying the allegations in the complaint, which was initially filed in November 2015.
Under the decree, Regeneca must destroy all dietary supplements and drugs within its possession within 20 days and under FDA supervision. It must also recall and destroy all supplements and drugs received, manufactured, prepared, packed, repacked, labeled, held, or distributed between June 1, 2011, and the date of the injunction. The company cannot resume operations until it meets a long list of requirements, including numerous good manufacturing practice improvements. It must retain an independent expert(s) to inspect the facilities, inventory and operations for GMP, labeling and marketing compliance once every six months for three years. Audit reports must be provided to FDA within five days of inspection. Regeneca must also hire a qualified independent lab to test its products for adulteration with unsafe food additives or pharmaceutical drugs. Operations can only resume after FDA issues written notification of compliance with the decree.
FDA sent Regeneca and Nicosia a warning letter in August 2012 advising that its RegeneSlim dietary supplement was labeled as containing 1,3-dimethylpentylamine HCL, another name for DMAA. The agency advised DMAA would be a new dietary ingredient (NDI) requiring notification; the products would be considered adulterated unless such a notification provided evidence the supplements contained only dietary ingredients as defined by law and would be safe when used as directed.
FDA stated it was not aware of any evidence showing DMAA is safe, and provided a counter argument that DMAA narrows blood vessels and arteries possibly leading to high blood pressure and cardiovascular malfunction, including heart attack. Further, the agency said it had reason to believe DMAA used in products marketed as supplements was made synthetically, which would exclude it from the statutory definition of a dietary ingredient.
In the legal complaint filed on Nov. 16, 2015, the Department of Justice alleged Regeneca introduced adulterated and misbranded products, including new drugs, into interstate commerce. It noted FDA inspected Regeneca facilities at various times during the summer of 2014, finding significant GMP “deviations," including failure to establish several specifications, conduct required testing and both prepare and follow mater manufacturing records. It was during these inspections that FDA collected and tested samples of RegeneSlim, confirming the presence of DMAA—two years after the warning letter. However, the product labeling no longer declares DMAA contents, so the products are misbranded, DOJ alleged.
In addition to FDA’s assertion DMAA is not a dietary ingredient, the complaint DOJ also stated DMAA is not generally recognized as safe (GRAS) for use in foods and is thus considered a food additive. “DMAA is not the subject of a regulation prescribing the conditions under which it may be safely used or an exemption for investigational use," the complaint stated. “Therefore, DMAA is a food additive that is deemed unsafe under 21 USC 348(a)."
The complaint further alleged Regeneca made unsubstantiated claims—intended to cure, mitigate, treat or prevent disease—for another ingredient (ChromeMate®, from InterHealth, a Lonza company) in Regeneca that rendered the product a new drug.
“[The] defendants have been warned about their ongoing violations," DOJ stated, in the complaint., citing the 2012 warning letter and the correspondence between FDA and Nicosia following the 2014 inspections. “[They] have a history of adding undeclared substances, including pharmaceutical ingredients, to products they market as dietary supplements … [they] have promised corrective actions, but they have consistently failed to achieve compliance with the law."