Regulatory 2016-10-18T14:15:41+00:00

FDA GRAS Status Earned

Phase2® meets all regulatory & technological criteria to be used in foods, beverages & health products. Phase2® is manufactured in the USA from non-GMO plant sources, cGMP Certified US made, fully traceable, and is FDA GRAS with daily ingestion of up to 10 grams per day.

GRAS Letter

Two US Structure/Function Claims

Since 2001, Phase2® has been the subject of numerous studies which have proven its safety and effectiveness. In 2006, the US Food & Drug Administration conducted an extensive review of clinical data and information on Phase2®, and announced that it does not object to weight control and starch reduction claims for Phase2®, and supplements containing it. With this announcement, Phase2® became the first nutritional ingredient with two permitted structure / function claims:

“May assist in weight control when used in conjunction with a sensible diet and exercise program,” and

“May reduce the enzymatic digestion of dietary starches.”

Clinical Studies

Official Weight Loss Claims in Canada

Phase 2 Carb Controller® has received a license from the Natural Health Products Directorate, Ottawa, Canada, to market the ingredient with two health claims:

“At 6 capsules (3000 mg) per day: Assists in weight management when used with a program of reduced intake of dietary calories and increased physical activity.”

“At 4-6 capsules (2000-3000 mg) per day: Provides support for healthy glucose metabolism following a carbohydrate rich meal.”

The claims are unique to Phase2® as the particular wording for the weight management claim is a rare phenomenon for licensed NHPs in Canada. Furthermore, the glucose metabolism claim emphasizes a ‘carbohydrate-rich meal’, which is valuable information to consumers as it reflects the true efficacy of Phase2® and its intended use.

European and Asian Claims / Permissions

For information about global claims and / or permissions, please email sales@pharmachemlabs.com.