Tongkat Ali root extract deemed safe at 200 mg per day, receives Health Canada NPN License.
HP Ingredients, Bradenton, FL, a manufacturer and supplier of organic non-GMO and sustainably wild-harvested patented herbal extracts, announced two significant regulatory and safety reviews that will greatly help marketers of its LJ 100 Ingredient for sports performance, maintaining high free testosterone levels, enhancing sexual function and promoting overall well-being, mood state and hormonal health.
Barry Lynch, director, Food and Nutrition Group, Intertek Scientific & Regulatory Consultancy (Intertek), reviewed a total of 56 studies (human clinicals and animal studies encompassing safety, mechanism of action and efficacy in a range of sexual and reproductive support issues and concluded, “The available information supports the safety of LJ 100 at the intake level of 200 mg per day. ”
In his written review (dated Feb. 16, 2016), Mr. Lynch asserted, “The components of this extract are consistent with the specifications established in the Malaysian Standard. Emphasis was placed on assessing the safety of incorporation of this specific aqueous extract of tongkat ali root into dietary supplement products and, further, to determine a dose not likely to cause significant adverse effects. Specifically, Intertek evaluated the safety of a proposed dosage of 200 mg/day in healthy adults.”
The report also pointed out that researchers have reported increased serum testosterone and DHEA concentrations in several clinical trials in which LJ100 was administered at doses of generally 200 mg/day or more. Other researchers have reported no such effect on testosterone and/or DHEA concentrations.
Mr. Lynch concluded that based on an exhaustive review of the available data that show a lack of serious adverse effects at doses of 200 to 600 mg/day, there is no indication that consumption of 200 mg/day of LJ100 would be associated with adverse effects.
“This review by INTERTEK further supports the safety of LJ 100 brand of standardized aqueous Eurycoma longifolia extract specifically and does not encompass generic Tongkat Ali alternatives,” said Annie Eng, founder and president of HP Ingredients.
In addition, Health Canada has recently concluded that HP Ingredients’ application for its proprietary Eurycoma longifolia ingredient known as LJ100 “is in compliance pursuant to section 7 of the Natural Health Products Regulations (NHPR),” and has thus issued product license NPN #80067049 for LJ100 capsules. Further, the following claims are now allowed to be made for Canadian LJ100 products (100 mg and 200 mg):
“Eurycoma longifolia helps support healthy sexual interest.”
“Eurycoma longifolia helps promote testosterone production.”
“Eurycoma longifolia supports testosterone production.”
“Eurycoma longifolia is a source of/provides antioxidants.”
“Our LJ 100 is one of the very few testosterone ingredients currently available on the market that has gone through this type of rigorous independent and third party safety review,” said Hame Persaud, executive vice president, HP Ingredients. “At a time when free testosterone enhancing products are under intense scrutiny, this should lay to rest any concerns regarding the safety of LJ 100 for oral dosage use in dietary supplements at its clinically evaluated levels.”
LJ 100 is an extract of Eurycoma longifolia (also known as Tongkat Ali) root extract, standardized to 22% Eurypeptides, 40% Glycosaponins, 1% eurycomanone (aqueous) natural compounds produced by Biotropics of Malaysia, which a patent has been issued jointly to the Government of Malaysia and the Massachusetts Institute of Technology (United States Patent #7,132,117). Eurycoma longifolia is a tall, slender shrubby tree that is indigenous to Southeast Asia, particularly in Malaysia, Indonesia, Thailand, and Myanmar. E. longifolia has a long tradition of use in the Southeast Asian culture as an herbal remedy to boost vitality.
LJ 100® is an extract of Eurycoma longifolia, (Longjack) Tongkat Ali root extract , standardized to 22% Eurypeptides, 40% Glycosaponins, 1% eurycomanone, protected by United States Patent #7,132,117, owned by Ministry of Science Malaysia and the Massachusetts Institute of Technology. Eurycoma longifolia is a tall, slender shrubby tree that is indigenous to Southeast Asia, particularly in Malaysia, Indonesia, Thailand, and Myanmar. E. longifolia has a long tradition of use in the Southeast Asian culture as an herbal remedy to boost vitality.
About HP Ingredients
HP Ingredients is a fast growing innovative nutraceutical company focused on bringing science based and patented natural remedies to the nutraceutical industry. HP Ingredients is dedicated to providing science based natural health solutions that are effective in supporting the most common chronic conditions affecting our lifestyle. Heart disease, diabetes, obesity, low testosterone and low energy are conditions that have become far too common. We work closely with team of scientists from around the world to bring you LJ100® Standardized Eurycoma Longifolia Extract (22% Bioactive Eurypeptides) for men’s health and sport nutrition; ParActin® – the first PPAR agonist to the market, effective for joint, bone, and muscle health; Bergamonte®, a science based nutraceutical for metabolic syndrome, cholesterol & blood glucose control, and weight management; Maqui Superberry™, a maqui standardized extract for blood glucose support; Citruslim® for cortisol control and healthy weight management; NO MaxTM for Antioxidant, vasodilating, and nitric oxide enhancer; NeuroActin® for brain cell protection, memory and cognitive health. Most of our scientists have been awarded several worldwide patents for their innovative works. All products intended for human consumption are certified Kosher and Halal.
About INTERTEK Health Services
INTERTEK Health Service International is a leading scientific consulting firm that specializes in developing scientific and global regulatory strategies, resolving toxicology and scientific issues and facilitating timely regulatory approvals for the food and dietary supplement industries. INTERTEK services include: ingredient and product safety assessments; expert scientific reviews; preparation of regulatory notifications and submissions [e.g., food additive and novel food petitions, natural health product (NHP) submissions, Generally Recognized As Safe (GRAS) and New Dietary Ingredient (NDI) notifications]; dietary intake/exposure estimates; study protocol development and placement of non-clinical toxicology testing programs; monitoring and auditing of safety and clinical trials; substantiation of health-related claims; and facilitation of global regulatory approval. For more information visit www.Intertek.com .