Potentially dangerous component in a dietary supplement - recall extended

Evira announced last week on 18 June 2012 on its website the recall of dietary supplement Jack3D: http://www.evira.fi/portal/en/food/product_recalls/?bid=3046

Evira has been alerted by the RASFF (Rapid Alert System for Food and Feed) that a dietary supplement containing 1,3-Dimethylamylamine (DMAA) has been imported to Finland. DMAA is a central nervous system stimulant related to amphetamine, and the safety of DMAA for human consumption has not been affirmed. Several serious side effects to the heart (Salinger et al. 2011) and brain (Gee et al. 2010) have been reported, particularly when combined with caffeine, thus demonstrating the serious health hazards DMAA can pose.

Risk assessment by the Danish and Swedish Food Safety Authorities has concluded that DMAA is not appropriate for human consumption due to its associated health risks. Potential health risks of DMAA have further been reported in e.g. Australia, New Zealand, Canada and the United States. The American Food and Drug Administration in the USA has also issued a warning concerning dietary supplements containing DMAA and restricted its use.

Evira is aware that dietary supplements containing 1,3-Dimethylamylamine (DMAA) have been available for sale in Finland as listed in the Table below:

Table in pdf-form http://www.evira.fi/files/attachments/en/food/manufacture_and_sales/jack3d_taulukko_en.pdf



Importer

Commercial name of product

Package size

Manufacturer

Fitnesstukku.fi, Fitnesstukku Store

OxyELITE Pro

90 capsules

USPLabs, USA



Crack

600 g

Revolutions, USA



Anabolic Beast

260 g

Star Nutrition, Sweden



Stacker Rush

454 g

Stacker 2 (NVE Pharmaceuticals), USA



Tested BURNER

68 capsules

Tested Nutrition, Canada



Hemo-Rage

294 g

Nutrex Research Inc., USA



Napalm

315 g

Muscle Warfare. Inc., USA



Lipo-6 Black

120 capsules

Nutrex Research Inc., USA

Wellneteus Ky

Hemo-Rage

908 g

Nutrex Research Inc., USA

SS-palvelut

Tested BURNER

68 capsules

Tested Nutrition, Canada

I&P Services Oy/PPS-Shop.fi

Geranamine 40 mg

90 capsules

Fusion Supplements

Manninen Nutraceuticals

Shock3D

180 capsules

Manninen Nutraceuticals

Active Nutrition International Oy

Mass Pump 3D

260 g

Mass Nutrition (Active Nutrition International Oy)

Reeni-ravinne.net

Shock3D

180 capsules

Manninen Nutraceuticals

SF Protein (FinnMax)

FinnMax Fast Track Super Treeniboosteri

150 g

SF Protein (FinnMax)

Ravinnetukku Aikalisä

FinnMax Fast Track Super Treeniboosteri

150 g

SF Protein (FinnMax)

Tampereen Urheilutuote Oy

FinnMax Fast Track Super Treeniboosteri

150 g

SF Protein (FinnMax)

Sportheavy/Rajantaka Oy

Shock3D

180 capsules

Manninen Nutraceuticals


For the most part, the product has been sold online throughout Finland via Internet retailers. Some items have also been sold at retail locations of the importing companies. The recall pertains to all batches of the products listed above.

The companies listed above have announced having discontinued the marketing of these products. Control authorities have ordered the companies to inform consumers about the unauthorised component of the product and how the products are to be returned (e.g. returned to the point of sale). The company that has marketed the product should be contacted if there are any questions related to the return of the product.

The matter is at Evira handled by:
Senior Officer Anna Mizrahi, tel. +358 (0) 29530 4295, GSM +358 (0) 50 434 2203, anna.mizrahi at-merkki.gif : 1 kB evira.fi