Regeneca Worldwide, a division of VivaCeuticals, Inc. in Las Vegas, is voluntarily recalling its RegenESlim appetite control dietary supplement due to the confirmed presence of DMAA in certain lots of the supplement. DMAA, also known as dimethylamylamine, methylhexanamine, or geranium oil/extract, is typically used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
The FDA has warned that DMAA is dangerous because it can narrow blood vessels and arteries and cause a corresponding rise in blood pressure or other cardiovascular problems, such as:
- Shortness of breath
- Arrhythmias
- Elevated blood pressure
- Tightening in the chest
- Heart attack
- Death
Until 2012, DMAA, which was first discovered by Eli Lilly and Company in 1944, was sold by numerous companies. It was marketed as the nasal decongestant Forthane until 1983, and reappeared as a dietary supplement in 2006. The FDA reported that by April 2013, it had received 86 adverse event reports from people who used DMAA, and in response sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market. These companies include:
- Exclusive Supplements – Biorhythm SSIN Juice
- Fahrenheit Nutrition – Lean Efx
- Gaspari Nutrition – Spirodex
- iSatori Global Technologies, LLC – PWR
- Muscle Warfare, Inc. – Napalm
- MuscleMeds Performance Technologies – Code Red
- Nutrex Research – Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
- Regeneca, Inc. – RegeneSlim
- SEI Pharmaceuticals – MethylHex 4,2
- SNI LLC – Nitric Blast
- USP Labs, LLC – Oxy Elite Pro, Jack3D
Although there have been no reported illnesses to date, the voluntary recall was the result of FDA analysis confirming the presence of DMAA in RegenESlim. Regeneca Worldwide is conducting a continuing investigation on the problem.
Customers who have purchased RegenESlim Lot #EX0616R15814 and Lot #11414RE5516 are advised to stop using the product immediately and return it to the place of purchase for a full refund. Adverse reactions to the supplement may be reported to the FDA’s MedWatch Adverse Event Reporting program online, fax, or via regular mail.
RegenESlim is purchased by and distributed through direct sales in the U.S. and Puerto Rico, and also through online sales for both personal use and retail sales.
