FDA Sends Warning Letter to Regeneca
According to the Dietary Supplement Health and Education Act of 1995, an NDI must show that ingredient has a history of use and evidence that establishes that the ingredient is reasonably expected to be safe when used as recommended. The letter also stated that even if the required NDI notification had been submitted, the agency has no evidence that establishes DMAA as reasonably expected to be safe, saying that "to the best of FDA's knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine [DMAA] will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack)."
The letter closed with a warning that if Regeneca didn't immediately cease distribution of RegeneSlim, the agency could seize the product and file an injunction against the company.
Related News
-
Regeneca Shutting Down
Regeneca Worldwide has been ordered to cease operations by the Department of Justice, which filed a consent decree of permanent injunction against the company and its CEO, Matthew Nicosia, alleging that they violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing Re... Read More...Regeneca Given Distribution Rights for CardioMap
Cottonwood Heights, UT June 11, 2015 -- Regeneca Worldwide has entered into an exclusive distribution agreement with VE Science Technologies LLC, the creators of the CardioMap heart screening and monitor device, for the network marketing industry."We are very excited about this deal, as the ... Read More...
Regeneca Worldwide Announces New President
Cottonwood Heights, UT May 14, 2015 -- Regeneca Worldwide has concluded their search for a new President and are pleased to announce that Mr. Trent Staggs will now lead the company in this role."We are thrilled to have Trent Staggs join the Regeneca team and lead the company's operations," s... Read More...
Regeneca Worldwide Recalls RegenESlim Capsules
Inc. Las Vegas, NV is conducting a voluntary nationwide recall of its RegenESlim appetite control dietary supplement from lot # EX0616R15814 and lot #11414RE5516 because FDA analysis confirmed the presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. ... Read More...
