Quality Issues in the Sports Nutrition Arena

Many segments of the market for sports supplements are the focus of intense government, public watchdog and media attention for various quality control issues relative to the truthfulness and legality of claims and content. While such scrutiny can certainly help the industry address problems, the negative exposure has put greater attention on dietary-supplement regulation and its nucleus of reputable companies.

Athletes of all skill levels turn to specialized supplements that can help them manage weight, muscle growth, energy and recovery, but they also seek more general health maintenance for optimal micronutrient levels and a healthy cardiovascular system. To this end, it is hard to put up a finite wall around the sports nutrition playing field. Still, the focuses of the sports supplement batting orderweight-control, muscle-building and energy-boosting productsare among the few key dietary supplement industry segments currently under doubtful eyes.

Both FDA and FTC have pumped up their actions in the area of weight-loss. With jurisdiction over advertising, FTC has warned companies about making misleading claims such as losing weight without alterations to exercise, diet or lifestyle. Kevin Trudeau and Mark Nutritionals are two of the bigger cases FTC has won, but the agency has also issued numerous warning letters to several dietary supplement companies for outrageous weight-loss claims in various media, including the Internet.

For its part, FDA has sent warning letters to companies whose "products marketed as supplements" have been found to contain pharmaceutical ingredients, such as sibutramine and bumetanide. In fact, the agency recently warned consumers not to take about 70 weight-loss "supplements" found to be adulterated; on this list is StarCaps, the supplement accused by five NFL players as the reason for their drug test failure for the diuretic bumetanide. FDA has said companies guilty of such adulteration face warning letters, which if not addressed by the companies, could be followed by seizures, fines and other penalties.

Patrick Luchsinger, marketing manager for Lipid Nutrition, conceded adulterated weight management products certainly reflect poorly on the supplement market, and his company welcomes more intense review of weight management products. "This vetting of claims and what the products actually contain will separate the pretenders from contenders based on the clinical evidence that can support the ingredient claims as well as improve the quality of the products themselves," he reasoned. "Those companies that cannot clinically support their ingredient claims will fall by the wayside while more scientifically based ingredient claims will continue on strengthening the sports nutrition market as a whole."

FDA has also gone after companies for marketing "supplements" adulterated with steroids or steroid precursors. This came after FDA actions in 2004 against androstenedione (andro) products that were marketed as dietary supplements, but did not follow FDA notification guidelines for new dietary ingredients (NDIs) not marketed before 1994. In the same year, Congress passed the Steroid Control Act of 2004, making andro and other steroid precursors controlled substances and thereby banned from use in dietary supplements.

NDI notification, part of the Dietary Supplement Health & Education Act (DSHEA), is an important regulation overlooked by many who claim dietary supplements are not regulated or are under-regulated compared to drugs.

When it comes to prohormones in sports supplements, biochemistssuch as the infamous Patrick Arnold, who brought the industry andro as well as the "clear," from BALCO and Barry Bonds infamycontinuously design new compounds to boost testosterone in the body. In fact, Arnold created 6-oxo (4-androstene-3,6,17-trione), the ingredient featured in the GNC-bought "supplement" accused by Philadelphia Phillies relief pitcher J.C. Romero as the cause of his failed drug test. Despite the complexities of this case, industry insiders are asking one major question: where is the NDI for 6-oxo?

"All of those prohormones, I'm not sure they were ever really legally sold, met the definition of supplement according to DSHEA," said Douglas Kalman, Ph.D., a clinical researcher at Miami Research Associates. "I don't recall, nor can I find an NDI submission [for 6-oxo and others], and yet there were claims that some of these prohormones, because they were found in the food supply, automatically met the definition imposed by DSHEA." He added FDA did rule these prohormones were drugs and not foodstuff, citing the numerous warning letters about lack of NDIs.

Kalman noted a lot of these compounds don't have human safety data or proof of concept data, which would show they work in the way their theoretical mechanisms say they should. "Just because you can predict the biochemical breakdown or physiological process in the body, doesn't mean it will actually occur that way," he said. "My issue is that many were never really tested in people, so consumers were basically their guinea pigs and that's scary."

Guilt by Association?

Unfortunately, there is an ongoing back-and-forth between industry advocates and critics over what is a satisfactory level of regulation for the industry and how deep these quality control issues really are.

That professional and Olympic athletes often blame "contaminated" dietary supplements for their failed performance-enhancing drug (PED) tests represents a big shining light on a problem that most agree is tied to a small percentage of rogue companies.

Doug Logan, head of U.S. Track and Field (USTAF), which has been particularly plagued by PEDs, has been outspoken about the quality issues he sees in sports supplements and the industry as a whole, although he recognizes the problem seems to come from a small group of outliers and outlaws, not the industry's core of reputable companies. "My own cardiologist has no faith in the dosages and quality of over-the-counter supplements, so he prescribes whatever supplements he wants me to take," Logan reported, noting this is the same issue he is dealing with relative to USTAF athletes. He said the World Anti-Doping Agency (WADA) has advised USTAF to tell its athletes not to take any dietary supplement, even multivitamins.

Elite athletes might make up a small percentage of the overall number of sports nutrition consumers, but they influence consumers and can generate powerful media stories on supplements. The Natural Marketing Institute (NMI) has attributed slow growth of the sports nutrition industry during the past few years, in part, to confidence issues surrounding the quality of sports supplements. Christine Smith, co-owner of Max Muscle's North Phoenix retail location, reported customers in her location are definitely influenced by the news on various sports supplement quality problems. "They are very interested in the quality of products in our store and become more comfortable after hearing about the extensive quality assurance procedures Max Muscle employs," she said.

The industry can't ignore the effect these media reports have on consumer confidence in sports supplements, which does make its way to regulators, as evidenced by the banning of andro and ephedra. "I get concerned for the industry as whole, not just sports nutrition, when this happens, because it's like taking two steps forward and one step back," Kalman said. "The industry has made major strides to gain greater acceptance and recognition as 'legitimate,' but every time something like this happens, it becomes that much harder for legitimate companies."

Despite the impact of these media-reported sports cases, supplement industry leaders noted these incidents should be taken in context. David Seckman, executive director of the Natural Products Association (NPA), cautioned it is important to remember substances banned by various sports leagues as performance enhancers are not necessarily dangerous or illegal. "Athletes have the right and responsibility to avoid their use," he said in a statement. "However, the consuming public who benefits from legitimate medications or dietary supplementsas well as a trip to the local coffee houseshould not be denied their use if an athlete is unwilling or unable to follow the rules established by their sport." He cited OTC cold remedies and prescription medications as legal, but often banned by sports leagues and governing bodies; caffeine is another example of a common ingredient that is off-limits to athletes but fine for regular consumers and sporting enthusiasts.

Stimulus Debate

What some of these legal ingredients have in common are stimulants, another category of sports nutrition facing some heightened scrutiny. FDA banned ephedra (ephedrine alkaloids) from dietary supplements in 2004 after it was allegedly at the root of a string of serious adverse events, including the high-profile death of Baltimore Orioles pitcher Steve Bechler; the agency determined ephedra posed an unreasonable risk. The market replacement for ephedra, which was used primarily in weight-loss and energy products, was Citrus aurantium (bitter orange). Not surprisingly, bitter orange found itself quickly under federal watch and investigation for its content of synephrine, which was said to be similar to ephedrine in composition. The National Center for Complementary and Alternative Medicine (NCCAM) even stated, "There is currently little evidence that bitter orange is safer to use than ephedra."

"However, the concept of bitter orange as an 'ephedra substitute' and the inference that bitter orange is pharmacologically similar to ephedrine (it isnt) caused some difficulties," said Bob Green, President of Nutratech, which makes Advantra Z. "In fact, while both bitter orange and ephedra are natural thermogenic ingredients and somewhat similar in chemical structure, they are completely different pharmacologically." In terms of safety, Green noted FDA was not able to directly link even one AER to bitter orange, and the agency quickly corrected its earlier misstatements on the matter.

"People have been greatly misled about the existence and depth of safety data on bitter orange," Green said. "Recent research has definitively answered these questions." He noted even a critic of performance-enhancing dietary supplements, Dr. Christine Haller of the University of California, San Francisco, has conducted studies that support Advantra Zs safety."

He further called on important third-party data conducted by Chromadex specifically on Advantra Z versus generic bitter orange, showing Advantra Z contains only p-synephrine, a stable isomer of the synephrine alkaloid, and does not contain any m-synephrine, which has the potential for raising blood pressure.

Frank Jaksch, CEO and co-founder, ChromaDex, said caffeine may draw the most scrutiny in the sports nutrition arena . The quality issue here is in the formulation and dosage. "Companies will include compound multiple sources of caffeinekola nut, yerba mate and other natural sourcesin one product," he said.

Truth and Testing

There are two primary goals in trying to solve the quality issues in sports nutrition. Flush out those companies that do not follow proper QC protocols or that purposefully contaminate supplements. Also, come up with better ways to provide athletes under PED testing requirements a plausible roster of dietary supplements approved in some way as safe and free from banned substances or those that can trigger false positives.

The power to take adulterated products off the market and rid the dietary supplement industry of companies that put adulterated products and illegal health claims on the market resides mostly in the federal government, both with FDA and FTC. Industry insiders and critics alike agree FDA has not used its powers to clean up this market, even after learning companies are marketing unsafe and illegal products.

One of the newer tools FDA has is its recently finalized GMPs for dietary supplements. Under these rules, companies manufacturing dietary supplements must follow specific procedures for sourcing, testing (identity, safety, etc.), packaging and storing raw materials and finished products, and documenting each step and batch. Theoretically, this should solve problems with inadvertent contamination.

Supplement insiders agree GMPs should help the situation, but how much it helps depends on how diligently FDA inspects manufacturers and holds failing companies accountable.

Kalman said of all the contamination cases he's seen, cross-contamination is by far the dominate culprit, not deliberate spiking. Fellow lab expert Jaksch agreed deliberation is exception, not the rule. He noted, "Deliberate adulteration is a very difficult practice to prove, in most cases." Either way, contamination should be weeded out by GMP inspection.

A number of industry-driven program have been used for years to separate the good quality from the poor quality. Among the earliest such programs, NPA's TruLabel program randomly tests finished supplements using independent laboratories. Participation is required of NPA member companies. In 2007, NPA reported none of the eight popular sports supplements tested in this program, were contaminated by steroids or stimulants.

Such testing is also undertaken by independent testing labs such as Miami Research and Chromadex. Both have many clients in the sports world and test products for contaminants, especially banned substances. Jaksch noted he has had products come through his lab that are contaminated, adding many companies come to him only after being accused or sued for contamination. He said it is crucial for companies to test for these contaminants before going to market.

NSF International has created certification programs to help sporting organizations and athletes minimize the risk of failing PED testing. It paired with the NFL Player's Association (NFLPA) to certify sports supplements for NFL players to take, and also created a similar, but broader program called Certified for Sport. The lab tests all batches of a particular product to ensure the supplements contain what is on the label and nothing more or less. EAS was the first company to have products pass the NFL program, and it also has passed the Certified for Sport tests, as have numerous other companies which can be found listed on the NSF Web site.

Edward Wyszumiala, general manager of NSF's Dietary Supplements Program, noted the program does not admit testosterone boosters, weight loss products and sexual enhancement formulas, three problem categories of the supplement industry, as evidenced by FDA and FTC actions. Some products tested by NSF have come up contaminated with banned substances, but these were supplied by leagues or athletes, not by companies submitting to the certification programs.

Why should the whole industry participate in these various lab testing programs, especially NSF's programs designed to help competitive athletes, which are a small part of the sports nutrition market?

"Companies that do not directly market to athletes and therefore may not view the program as necessary are missing the overall purpose of the program," Wyszumilala said, adding the program is not designed just for sports supplements, but is designed for multi-vitamins and fish oils as well. "When talking with athletes, coaches and trainers, one theme resonates again and againwhich vitamin, mineral, fish oil, glucosamine-chondroitin formulas are certified."

Logan, who is in favor of tighter regulation and enforcement against problem ingredients and products, said testing programs such as NSF's, NPA's and others have the potential to help both athletes and industry. He suggested industry go to WADA with an offer to create such a program for international sports. "Those industry groups that wanted to do it, I'd go to USADA with them," he said. "At the end of the day, it could resolve many problems for me."

At the end of the day, there is a quality control problem in the sports supplement industry, albeit some debatable ratio of perceived and true adulteration. Wild and illegal claims and advertising contribute to the attention this category receives from consumers and regulators, and the industry's self-regulation only addresses so much of the problem. The trick will be finding a way to stifle the negative press and grow the nucleus of supplement companies making and marketing sports supplements in a safe responsible and high-quality manner.

The Quality Control section is sponsored by Ethical Naturals; however, the company does not review or approve editorial content.