Health Canada Relaxes P Synephrine Rules

OTTAWAHealth Canada relaxed and redefined its guidelines for the use of p synephrine, a compound found in the thermogenic ingredient bitter orange extract. Previously, Health Canada limited daily intake of p-synephrine to 30 mg, and products containing both p-synephrine and caffeine were prohibited without extensive human clinical studies. Now, Health Canada will require cautionary label statements on products containing more than 50 mg p-synephrine, and allows products with 40 mg of p-synephrine in combination with 320 mg of caffeine.

Products with more than 50 mg  of p-synephrine will need to carry labels that say this dosage should be avoided by children, women who are pregnant and nursing, and people who take blood pressure and/or thyroid medications, sympathomimetics or monoamine oxidase inhibitiors (MAOIs).

The agency also now classifies 1 mg/d to 50 mg/d of p-synephrine as a Type III health risk:  a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences" for healthy adults. Products providing up to 40 mg of p-synephrine in combination with a maximum of 320 mg of caffeine per day also have Type III classifications.

 Products containing greater amounts of these ingredients are now classified as Type II:  a situation in which use of, or exposure to, a product may cause temporary adverse consequences or where the possibility of serious adverse health consequences is remote."

This is very good news for makers of weight management, sports nutrition and energy supplements," said Bob Green, president of Nutratech Inc., exclusive distributor of  Advantra Z, a patented bitter orange extract. "Not only because Health Canadas report validates the safety of Advantra Z and p synephrine, but also because this government agency has looked past the hype and evaluated the scientific data behind this tried-and-true thermogenic ingredient."

At Greens request, Sidney J. Stohs, a researcher of performance-enhancing ingredients and co-author of a definitive scientific review on "The Safety of Citrus aurantium (Bitter Orange) and its Primary Protoalkaloid p Synephrine"  (Phytotherapy Research, April 2011) provided Health Canada with up-to-date clinical studies and scientific literature available.

Health Canadas recommended limit of 30 mg of p-synephrine per day was an arbitrary number not supported by scientific research," Stohs said.  Especially when you consider that some types of orange juice contain up to 40 mg of p-synephrine in a single glass."

In the 49-page health risk assessment report, Health Canada reviews p synephrines chemistry; receptor binding, in vitro, animal and human studies; summaries of clinical case reports; and Canadian clinical case reports.  It concludes that although p synephrine-containing products have been implicated in adverse event case reports, causality is not likely due to the p-synephrine content on its own, but rather due to other ingredients."  The report also addresses misconceptions and misinformation concerning the safety of p-synephrine and establishes the new dosing guidelines.