The DMAA Low Down.
§ In the US, the FDA gave 10 major companies selling products with DMAA, 14 days to respond with evidence proving the safety of DMAA.
§ The majority of these companies chose to remove their products from sale within this time period.
§ USP Labs submitted a 250 page document on the safety of DMAA.
§ The document was prepared by their Legal Attorney whos background was originally a senior role within the FDA itself.
§ This very impressive document is now being reviewed by the FDA who are still yet to respond to its contents. As such, USP Labs products containing DMAA are still available for sale within the US.
§ In Australia, USP Labs have also taken market leadership and have made a submission in response to the TGA Proposal to include DMAA as a Schedule 9 Ingredient.
§ This was prepared by some of the top legal counsel and Regulatory Consultants in Australia.
§ Due to this submission, a response process is now required from the TGA. Up until now, no reason has been publically cited yet for the proposed Schedule 9.
§ Due to this, legal opinion has now indicated that the earliest date for a decision to be made on whether DMAA will be included as a Schedule 9 has been shifted from 1st September to the 10th of October.
Further to this a warning has been sent out from Food Standards Australia New Zealand in regards to DMAA. (This is available to read at the bottom of this email.)
§ This warning effectively states that they have tested 12 products for DMAA and that 11 of them did in fact contain DMAA. We would be intrigued to know which product of the 12 did not.
§ They cite anecdotal evidence of links in other countries to adverse health effects but do not provide any evidence of this.
§ Their Deputy Chief Executive Officer has advised consumers not to consume DMAA.
Jun. 18, 2012 8:30amFood Standards Australia New Zealand | Engredea News & Analysis
Food Standards Australia New Zealand (FSANZ) today issued a warning about supplementary sports foods containing an ingredient known as DMAA.
FSANZ is working with state and territory government agencies and departments to investigate a range of products following complaints from consumers and some adverse health reports linked to products containing DMAA or 1,3-dimethylamylamine.
FSANZ Deputy Chief Executive Officer, Melanie Fisher, said the products were typically used as a pre-workout supplement.
“The New South Wales Food Authority has tested 12 of these products and 11 have tested positive for DMAA,” Ms Fisher said.
“DMAA has been linked in other countries with various adverse health effects including high blood pressure and vomiting and there have been a couple of adverse health reports in Australia,” Ms Fisher said.
“Regulatory agencies are working together to assess the products’ safety and are currently seeking the assistance of retailers; importers and distributors on a withdrawal of the products.”
The Federal Department of Health and Ageing is looking at whether DMAA should become a prohibited substance and has sought advice from the Advisory Committee on Medicines Scheduling, which is meeting later this month where this issue will be urgently discussed.
“Consumers that have purchased the sports food products listed below should not consume the product and discard it,” Ms Fisher said.
If you have consumed these products and are concerned about your health please seek medical advice.
Brands testing positive for DMAA: Noxpump; 3-D explosion; Beta-Cret; PreSurge; 1 MR; Cyroshock,; Jack3D; Mesomorph; Neurocore; Oxyelite powder; Hemo Rage Black.
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