On July 19th, nutraingredients.com reported an impending “slaughterfest” of sports nutrition products due to the investigation of 431 performance-enhancing products by British Medical Journal (BMJ). According to the article, the products in question allegedly contain “dangerous steroids, stimulants and hormones” and lack scientific backing for health claims. On July 23rd, not even a week later, the same website published an article about the U.K. medicines regulator MHRA busting 84 sports supplements for containing “dangerous ingredients.”

Clearly, something is about to happen to the category on a grand scale. After years of quiet marketing and, let’s say, not exactly legal ingredients or substantiated claims, regulators are about to take a closer look at what it says on these products’ labels.
 

Now that the Health Claim Regulation has fully come into effect (published in June), complete with a positive list of Article 13.1 (generic) health claims, food products, including supplements and sports nutrition products, should get ready to have their label claims scrutinized.

An unsubstantiated health claim is one thing, but a “dangerous ingredient” (i.e., one that carries serious safety concerns) is quite another. Several substances, such as ephedrine, synephrine and yohimbine, have been in the regulatory spotlight for years due to their connection to serious health issues such as kidney failure, seizures and heart problems. Other substances, such as DMAA, are doping substances and not legally marketable in food products—which, so far, does not prevent any of them from being included in other product compositions.

Recently, Sweden and Finland have banned products that contain DMAA. Ireland has declared them “illegal medicines.” And on the other side of the globe, Australia has gone as far as to add the substance to its poisons list. This could be a first step in a series of outlawed sports nutrition substances of questionable marketability.

It is time for manufacturers to be proactive about their products’ label claims and compositions, and remove questionable substances and claims before watchdog organizations set their sights on them. 

Article 13.1 claims and their wordings, as published in the annex of the Health Claims Regulation, can be used by everyone, provided that the conditions of use are met. One of the permitted health claims for calcium is “contributes to normal muscle function and neurotransmission,” which is a nice health claim to make on a sports nutrition product. Other ingredients whose use allows a permitted health claim include magnesium (“contributes to normal muscle contraction”) and potassium (“contributes to normal muscular and neurological function”).

These health claims not only apply to athletes, but also to the general population, which opens up a nice opportunity for manufacturers looking to target other consumer groups. In recent years, demographics other than athletes, most notably women and the elderly, have discovered sports nutrition products as a way to supplement their diets with protein in an effort to maintain lean muscle mass. The previously mentioned claims make it possible to target them specifically, as long as adequate amounts of these nutrients are added to formulations.

Carbohydrate-electrolyte solutions that contain 80-350 Kcal/L from carbohydrates may carry the claims “contributes to the maintenance of endurance performance” and “enhances water absorption during exercise.” Vitamin C, if included to reach 15% of the RDA per day, can be claimed to “improve the function of the immune system during/after extreme physical exercise.” All these claims are targeted at subjects performing intense exercise, i.e. athletes.

And then there’s creatine. If products use 3 grams as the daily dosage, they may carry the claim “increases physical performance during short-term, high intensity exercise.” 
 

Currently there are no permitted health claims for category favorites such as protein, single or compound amino acids, taurine, carnitine, guarana, and all the rest. There are no permitted claims referencing “anabolic,” “energizing,” “boosting,” “muscle growth” or similar terms. 

In the end, at least from a marketing standpoint, products that comply with regulations will look pretty unimpressive next to their illegally labeled shelf mates. This is the quandary for manufacturers, who now have to decide whether they want to just leave things as they are and hope for the best—which, in view of recent developments is not a very promising strategy—or if they should clean up their portfolios and make the most of existing claims. 

---

Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: jgruenwald@analyze-realize.com; Website: www.analyze-realize.com.