Natural Remedies, offering patented, clinically-substantiated, scientifically-validated innovative branded ingredients, has received a self-GRAS status from Florida-based Soni & Associates Inc. for its standardized Bacopa extract derived from the aerial parts of the plant Bacopa monniera as a food ingredient.

The GRAS conclusion was based on a critical evaluation of the publicly available data and in accordance with section 201 (s) of the Federal Food, Drug and Cosmetic Act of the United States. The expert panel members individually and collectively concluded that Bacopa extract (BacoMind) prepared from the aerial parts of the plant Bacopa monniera, meeting the specifications cited in the GRAS dossier, is safe when used at a maximum of 50 mg BacoMind per serving (reference amounts customarily consumed, 21 CFR 101.12) in specific foods—such as, non-alcoholic beverages, candies (including gummies or chews, etc.,) and bakery products (including breakfast bars)—and resulting in an estimated maximum daily intake of 316 mg of BacoMind per person.  

“As pioneers in bringing Bacopa to the industry, we are pleased with the GRAS acceptance of branded Bacopa—BacoMind for brain health support. BacoMind is the first branded bacopa extract to receive GRAS status,” said Suresh Lakshmikanthan, global head of Human Health Business for Natural Remedies. “We are making good progress with customer acquisition through our patented, clinically tested, memory and cognition function ingredient; it is standardized to contain a unique full spectrum of nine different bioactives of Bacopa monneri.

Bacopa monnieri, is a plant revered in Ayurveda, with a long-standing reputation for its memory and cognitive health properties.

“Challenges in sourcing Bacopa included unavailability of Bacopa without pesticides, ochratoxins and a sustainable supply chain,” said Lakshmikanthan. “We solved those problems by selecting farms with ideal conditions for cultivation, and training farmers on safe and sustainable cultivation methods to cultivate Bacopa as a pure crop, free from contamination, with regular quality checks to produce BacoMind.”

Natural Remedies contributed in improving the quality of Indian botanicals with active participation in preparation of analytical monographs for various international pharmacopoeias. Natural Remedies is also a leading manufacturer and supplier of phytochemical reference standards from Indian medicinal plants, which are being used for quality and research purposes globally.

Natural Remedies’ human healthcare products provide quality combined with expertise while offering global clients a one-stop-shop fulfilling their requirements of quality health supplements and formulation ingredients.
AIDP, Inc., a frontrunner in functional ingredients with a focus on extensively researched products is the exclusive distributor of BacoMind in North America.