Insider’s Update on the Regulatory Issues Surrounding Sports Supplements

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TweetInsider’s Update on the Regulatory Issues Surrounding Sports Supplements



There was a 22-year-old aspiring bodybuilder who claimed that he used creatine monohydrate at recommended doses for three and a half months. What happened to him? Well, here’s how journalists presented the case in the papers.

The story begins by describing the "deep blue and red scar [that] carves the skin on the outside of both of [his] legs, from his hips to his ankles. Orthopedic surgeons’ scalpels have sliced them open again and again over the past five months to save his life and legs." It continues with: "‘After the fourth day they wanted to amputate both legs at the hip,’ he said. ‘They were afraid the decay would spread to my lower intestines.’" He suffered liver and kidney failure and the loss of the full use of his legs. Finally, the story proceeds to: "What caused all the problems? ‘The doctors … told me it was the creatine,’ he said. ‘My body wouldn’t process it.’ It ended up poisoning him." The story was tossed to the public without any comments from nutrition experts or even the doctors who supposedly attributed the horrific symptoms to creatine monohydrate.

This story is extreme. But it’s not atypical. Bad press on dietary supplements is the norm today in mainstream journalism. The media is always looking for a negative scare story. People will watch if it’s, "Something in your refrigerator is killing you. Film at 11." Bad press also brings about regulatory efforts. Despite a multitude of scientific facts to the contrary, the deaths of Korey Stringer and Steve Bechler were blamed on ephedra. If they were still playing ball today, ephedra might never have been banned.

In addition to the media, the dietary supplement industry faces criticism from two other fronts – the mainstream medical community and legislators and regulators.

The folks at the University of California, Berkeley Wellness Letter, while conceding that some supplements are beneficial, recently made this statement:

"In 1994 federal legislation – the Dietary Supplement Health and Education Act, passed after intensive lobbying by the supplements industry – essentially removed so-called "dietary supplements" from FDA control. Manufacturers can now suggest almost anything on their packages and in ads, without any proof of safety or efficacy, but in theory at least, cannot make medical claims. Flawed studies are vigorously cited in support of dubious or even dangerous products. Studies that show a negative effect are never mentioned, and indeed may never be published."

The "you can get all the vitamins you need from food" position is still prevalent among physicians and even among dieticians and those in the traditional food and drug community. At a recent Food and Drug Law Institute conference I attended in Washington, one long-time food and drug lawyer said, "I’m a traditional food and drugs lawyer. It’s one or the other. I just don’t get supplements."

The other front is from legislators and regulators. FDA has shown a history of bias against supplements. In fact, it was FDA’s bias that caused the enactment of DSHEA. In its official report about the need for DSHEA to curtail excessive of dietary supplements, the Senate committee debating DSHEA stated explicitly, "in fact, FDA has been distorting the law in its actions to try to prevent the marketing of safe dietary supplement substances."

However, DSHEA did not leave FDA paralyzed. Despite media statements to the contrary, the industry is not an unregulated industry. In fact, DSHEA ensured FDA’s authority to provide legitimate protections for the public health. The Food, Drug, and Cosmetic Act prohibits introducing adulterated products into interstate commerce, with associated criminal penalties. Several grounds exist by which unsafe dietary supplements can be deemed "adulterated". While the Secretary of Health and Human Services has the power to declare a dangerous supplement to be an "imminent hazard" to public health or safety and suspend sales of the product, FDA also has the authority to protect consumers from dietary supplements that don’t present an imminent hazard to the public but do present certain risks of illness or injury to consumers. One provision, which applies to all dietary supplements, states that a supplement shall be deemed adulterated if it presents "a significant or unreasonable risk of illness or injury under … conditions of use recommended or suggested in labeling, or … if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use." The standard doesn’t require proof that consumers have actually been harmed, or even that a product will harm anyone.

Some legislators today overlook the reason DSHEA was enacted, and fail to see or ignore the fact that these are not black and white issues, but ones with many shades of gray. Senator Richard Durbin of Illinois, a long-time critic and opponent of the dietary supplement industry, recently addressed Congress in promoting a bill he is sponsoring that would put safety burdens on industry and criminalize certain supplements:

"People unsuspectingly go into these health food stores, vitamin stores, and see the dietary supplements with all sorts of claims on them; they buy them, they use them, and the consumers of America become the guinea pigs."

"I am happy to see the administration, after more than a year of urging, finally banning ephedra, but more has to be done. Today as we speak, innocent children and consumers across America are buying products which they presume to be safe and they are not. "

The issue concerns more than simply which supplements are dangerous and which are not. The issues are also whether American consumers are going to be allowed to have a substantial say in their own health choices, and whether our industry is going to take some responsibility to make sure that we are trusted and respected. Those of you here today are the leaders, the ones who can set an example and insure that our industry remains vibrant and alive.

All of these factors – the media, FDA’s bias, the politicization of our health policies which should be based on science not votes – are causing a backlash against DSHEA, and the potential for heightened regulation of the whole dietary supplement industry.

I want to spend the rest of our brief time together speaking about how to address these issues with specific respect to the sports nutrition supplement segment of the market and what we, as responsible members can do. I see important differences between sports nutrition supplements and others. Sports nutrition products have all the same critics I described earlier. The safety issue is still a big concern expressed in the press.

The issue of safety is constantly waived as a red flag against the use of sports supplements. For example, take the warning that NCAA student-athletes get about supplements. The flyer shows capsules, a bottle of creatine, and some sports nutrition bars, and warns, "Dietary supplements are not strictly regulated and may contain substances banned by the NCAA. What’s in the bottle is not always on the label. If you don’t know what you’re taking, you are risking both your health and your eligibility."

At the recent International Symposium of Supplements in Sports held a few weeks ago in Montreal, the officially expressed outcome of the Symposium:

"The use of nutritional supplements in sport is a matter of great concern. It represents a significant doping risk with all too often devastating consequences for athletes. In addition to the possibility of inadvertent doping from the consumption of a contaminated or mislabelled supplement, athletes face problems including risks to health and safety."

But sports nutrition products have another strike against them that really changes the so-called playing field. It is the All-American belief that everyone should play fair and that no one should have an unfair competitive advantage. If a "performance-enhancing substance" gives one athlete an unfair advantage over another, and may also have a coercive effect on those who choose not to take the products, then it is considered unethical in sports by its very nature. It is contrary to the cherished concept of the "level playing field."

I’ve spent a substantial amount of the last two years keeping my finger on the pulse of the Hill. I’ve sat down with Senator Hatch personally about DSHEA, worked with two different lobbying firms, and personally met with dozens of House and Senate staffers. Fairness in sports is a bipartisan value, and an important one on Capitol Hill.

Take Senator John McCain’s campaign against performance-enhancing substances in sport. He’s been fanning the flames of the BALCO investigation and has been a strong critic of prohormone products. He recently said in a Senate hearing on the issue: "No reasonable person could disagree that using a performance-enhancing substance to gain a competitive edge over an opponent is cheating."

President Bush’s State of the Union address attacked steroids not primarily from the health risks angle, but because they send "the wrong message" regarding fairness in sports.

But what these messages ignore is that there are tens of thousands of adult Americans who take these products not to gain an unfair advantage in high level athletics but who want to have the right to take these products to maintain their youth, their vigor and their sex appeal. There is nothing wrong with that and every American should have the right to make that choice. But that choice is being taken away from them.

Even the Drug Enforcement Administration has gotten involved. Five years ago, communications between industry and DEA led to a presentation on androstenedione to DEA and FDA brass at DEA headquarters in Virginia. I had the opportunity to be the first lawyer "on the ground" on this issue, having been asked to spearhead the presentation on behalf of industry. With a coterie of scientists, a physician, and several industry insiders in tow, I presented my case to DEA as to why andro was not and could not be classified as an anabolic steroid under federal law as written.

Ultimately, FDA this year stepped in and issued warning letters and press statements that it had found andro to fall short of the requirements of a new dietary ingredient, those requirements being either: (1) the supplement in question contains "only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered"; or (2) there is a "history of use or other evidence of safety" provided by the manufacturer or distributor to FDA at least 75 days before introducing the product into interstate commerce. [For analysis, see, R. Collins & A. Feldstein, "‘Adulterated’ Androstenedione: What FDA’s Action against Andro Means for Industry," Sports Nutrition Review Journal. 1(1):52-60, 2004.].

Pressure is mounting as more and more anabolic steroid precursor products are brought to market. Typically, these are "new dietary ingredients" that were not marketed in the U.S. prior to October of 1994. Accordingly, they have to meet specific requirements under DSHEA. Some of the products appear not to meet these requirements.

FDA has also begun more closely examining the contents of sports nutrition products. For example, I am currently defending an investigation by FDA authorities and a U.S. Attorney’s Office against a prohormone distributor whose products were allegedly adulterated with illegal anabolic steroids. The FDA assumes he spiked them – but the contamination was probably more likely the result of sloppy procedures at the overseas manufacturing facility where the raw powders are created.

While the FDA may attack other prohormones or prohormone manufacturers, it’s likely that imminent action may be legislative rather than regulatory. Several federal bills are pending which would relegate prohormone products to controlled substance status, making their distribution a federal felony and their mere possession by health-conscious, adult consumers a federal crime. Are we prepared to make upstanding law abiding citizens into criminals because they want to look and feel younger?

Other sports supplements have come within the sights of the sports watchdog agencies. While prohormone products were banned in many sports, dietary supplement products that were not on the banned list were causing problems due to cross-contamination at the manufacturing stage. The International Olympic Committee (IOC) released a study after the 2002 Winter Olympics that found that 15 percent of over 600 sports nutrition supplements purchased worldwide were contaminated with banned substances not listed on their labels. The World Anti-Doping Agency, the IOC and the U.S. Olympic Committee responded by warning athletes to avoid supplements entirely to eliminate the risk of inadvertent positive tests from mislabeled or contaminated products. Clearly, a broad attack on this segment of the industry had begun.

This is the battlefield that we find ourselves in. Clearly, the fitness community and sports nutrition supplement industry have allowed the enemies to breach the walls. The industry has done this by not policing itself, by allowing some marketers to make outrageous claims and engage in unseemly marketing tactics. Questionable products have been brought to market. Purity remains an issue. Industry has not done enough scientific research and most importantly has not set aside the competitive battle for market share in order to work together to turn the tide of this onslaught.

All is not lost however. There is still opportunity. The year to come will be a pivotal time for the long-term survival of this market. The anti-doping watchdogs have conceded that the "just-say-no" approach to supplements isn’t working and mostly alienates athletes. With ephedra and andro gone, and all steroid precursors soon to follow, the industry has an opportunity to regroup and redefine what it’s about.

What does this mean for the products on the market today and those yet to be brought to market? To succeed we must adopt a multi-prong approach.

First, we must start self-regulating. The Montreal Symposium on supplements in sports, for example, concluded that it was "essential" for the industry to start self-regulating to improve product quality, minimize contamination, and label products accurately. That makes sense. As with other self-regulating industries, an association must create industry standards and policies. It must establish a relationship with regulatory agencies, and communicate directly with them. If the significant majority of the industry joins the association and adheres to its standards and policies, regulatory agencies will be inclined to direct their time and enforcement resources toward those who do not. However, unless the significant majority of the industry joins the association and adheres to its standards and policies, self-regulation will not succeed. The alternative – heightened government regulation – will be less favorable.

Second, more research needs to be performed. The custom of bringing new dietary ingredients to market with little or no research on safety and efficacy must be jettisoned in favor of a policy of quality research. Also, if a new product is to be marketed based upon the exemption for presence in the food supply, confirmatory research should be conducted. Generally, scientists and researchers must help industry to create a research environment that will benefit industry.

Third, industry must be proactive. It is too late to jump up and down and complain when the passage of legislation is imminent. Industry must form a well-funded coalition that will educate the public, the media, legislators and bureaucrats about the true facts regarding the industry and its products. This will require public relations, government affairs and legal efforts. One group already exists – the USFA (www.usfa.biz) – but until everyone, manufacturers, distributors, raw material suppliers and retailers join in, the effort cannot succeed.

Fourth, we must educate the public about the risk they face. Nothing speaks louder to legislators, and thus in turn regulators, than a public outcry from their constituents about what is being done. Before the passage of DSHEA there was a huge outpouring from the public. If more Americans knew they would be branded drug criminals for using certain health food store products, I assure you their legislative representatives would hear from them. This is not just an issue about supplements. It is an issue about Freedom and an issue about Choice. Those are American ideals that must not be taken away.

So, I put this challenge to you, the leaders in this industry. If we can put these efforts in place we can not only survive, but also emerge a better and stronger industry. We must work together now. If we don’t, we will see our industry shrink and erode until there is little if anything left. The choice is ours.

[PIT]

TweetGood read.

Bump.