This week OTCs are in Action in Japan, where Otsuka has introduced Nature Made Ginkgo Biloba, Japan’s first Food with Function Claim for cognitive function. Research has shown that flavonoid glycosides and terpene lactones extracted from ginkgo biloba can improve perception and recall of perceived objects.
According to Otsuka: “Traditionally prized in Europe for its health benefits, ginkgo biloba has also been recognized as a health food in Japan for many years. A systematic review of research results for flavonoid glycosides and terpene lactones extracted from ginkgo biloba leaves led to notification and acceptance of this supplement as Japan’s first Food with Function Claim for cognitive function.” Nature Made Gingko Biloba is delivered in tablet form.
The Food with Function regulatory classification was introduced in April 2015 and allows food supplements to be supported by nutrient claims, as long as scientific evidence has been provided to the Consumer Affairs Agency, reports the December issue of Nicholas Hall’s OTC INSIGHT Asia-Pacific. Unlike Foods for Specified Health Use, these products are not subject to case-by-case review by the agency.
Another recent innovation from Otsuka offers heart health benefits to Japanese consumers. In November, the company expanded claims for Nature Made Super Fish Oil in Japan with the specific health benefit of “inhibition of triglyceride levels in the blood”.
On a final note, the OTCs in Action team wishes our readers a healthy, safe and happy New Year!
This week’s OTCs in Action starts out in Philadelphia, where last week some Germans who came to visit me purchased the dietary supplement melatonin for personal use, because it’s only available on prescription at home. The German OTC sleep aids market is largely composed of natural products, such as valerian and homeopathic remedies, so it was somewhat surprising that melatonin is not available OTC.
In contrast, the Cologne Administrative Court overturned a ban on the calming herb, kava kava, last year. Owing to concerns about liver toxicity, the ingredient was withdrawn from most European markets in 2002, and the FDA issued a warning letter discouraging use of the product in the US. Subsequent research has indicated that the original studies were flawed, and the German court ruled that the risks did not outweigh the ingredient’s benefits.
Click on this link to access OTC INSIGHT Europe’s latest report on the German OTC sleep aids market.
Elsewhere in Europe, France has approved the Rx-to-OTC switch of Biocodex’s Dolenio (glucosamine 1,178mg, 30-tab pack), a slow-acting anti-arthritis medicine. This follows the dereimbursement of several anti-arthritis brands, which had been reimbursed at 15% when prescribed by a doctor. Affected brands included Piasclédine (Expanscience, avocado-soybean unsaponifiables), Chondrosulf (Genévrier / IBSA, chondroitin sulphate), Art 50 (Negma, diacerein) and Voltaflex (Novartis, glucosamine).
Piasclédine and Chondrosulf (in particular) used to command huge sales as semi-ethical brands in France, but now face a challenging, but potentially lucrative, new future in the self-medication sphere.
Decades from now, could the peanut-free table in school lunch rooms be a social relic of the early 2000s?
Today, peanuts are the most common cause of fatality owing to food-induced anaphylaxis. However, there is very exciting news that OTC probiotics may play a role in eliminating the allergy for many children. Researchers at Murdoch Children’s Research Institute in Parkville, Australia, have announced the successful trial of a treatment for peanut allergies. In the study, researchers gave more than 60 peanut allergic children either a placebo or a dose of a probiotic (Lactobacillus rhamnosus), together with peanut protein in increasing amounts over an 18-month period. The result: More than 80% of children who received the oral immunotherapy treatment were able to tolerate peanuts at the end of the trial, compared to less than 4% of the placebo group. This is 20 times higher than the natural rate of resolution for peanut allergy. According to the announcement, “23 of 28 (82.1%) probiotic treated children and one of 28 (3.6%) placebo-treated children were able to include peanut in their diet at the end of the trial.”
Lead researcher, Professor Mimi Tang, said the study results are extremely exciting as they could potentially provide an effective treatment for food allergy: “In the study the combined delivery of probiotic and oral immunotherapy was a safe and effective treatment for peanut allergy; however, it is important to point out that this treatment must only be given under close medical supervision as we are giving peanut to children who are allergic to peanut and children did have allergic reactions. Nevertheless, the likelihood of success was high – if nine children were given probiotic and peanut therapy, seven would benefit.”
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OTCs in Action thanks the weekly newsletter, OTC.NewDirections, published by Nicholas Hall & Co, for tracking scientific advancements in healthcare as they are announced.
This month, US Federal Trade Commission Chairwoman Edith Ramirez cautioned marketers of brain health supplements that the National Advertising Division is watching them. In a keynote speech at the NAD’s conference, Ramirez said companies who conduct false and misleading marketing campaigns for these products prey on consumers’ fears of ageing and hope for their children. The agency has prioritised taking action on companies that take advantage of consumers this way.
For example, the NAD’s latest action targeted SmartX from Cerebral Success, which has agreed to refrain from making a wide range of claims, such as “Cerebral Success was specifically designed as a study pill to provide an Adderall alternative for students who are taking the drug without a prescription. It is not, however, designed to treat the condition. Along with focus and mental energy (the hallmarks of Adderall), Cerebral Success was designed to increase memory and strengthen and protect the brain, which Adderall does not do.”
This type of borderline disease claim-making is so damaging to the credibility of a category that can truly help people. In fact, brain health has been hailed as the next big dietary supplement boom. Therefore, we spotlight this week’s OTC in Action, i-Health’s BrainStrong Memory Support, which has been reformulated and relaunched after reaching a settlement with the NAD regarding previous claims for cognition and memory health. Legal analysts say the settlement requires that the quality and quantity of scientific evidence must prove the specific claim for the brand, a departure from the two-study standard previously accepted. The order also includes a provision that data is collected and documented by the company.
BrainStrong’s new positioning has undergone trial by fire:
BrainStrong Memory Support is a breakthrough new formula containing gingko biloba and choline – two ingredients scientifically demonstrated to help support brain signals, sharpen focus and support a healthy memory. The website also encourages consumers to “Support your memory … and save money too!”
And the lower cost should encourage trial by consumers!