Sports Supplements Are Regulated

To the editor (Times Herald-Record, Hudson Valley, New York state):

Your special report, “Supplements for athletes stir serious debate” (June 29, 2010) is interesting but presents some misleading ideas.

For example, the quote that “18.8 percent of supplements are tainted with steroids or other illegal, potentially dangerous ingredients” is seriously flawed, since the percentage actually refers to 240 sports supplements tested, a tiny fraction of the tens of thousands of dietary supplements on the market. These products were actually tested 9 years ago when steroid precursors were legal; spiking them with steroids was always illegal. Today, thanks in part to the dietary supplement industry lobbying for a federal ban on steroid precursors, that product category is dead and this inflammatory quote does not reflect the present market. If any illegal drug is present in a product it is defined by law as an unapproved drug, not a dietary supplement, subject to FDA and DEA enforcement.

Regarding Senator McCain’s bill to more strictly regulate supplements: I met with him after the bill was introduced to present the inconsistencies between the actual bill and how he described it. Under the anti-bioterrorism bill of 2003 all dietary supplement manufacturers are already required to register with the FDA; as do all domestic or foreign food manufacturers selling in the US. Under several federal laws all ingredients already must be on dietary supplement labels. Failure to do so makes the products adulterated and subject to a range of FDA actions. His bill would actually have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy and amounting to a government takeover of the entire dietary supplement industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products on the Canadian market, products considered safe in the US are effectively banned, waits of over 4 years to introduce variations of existing products, higher prices, etc.

Your series promises to disclose how the dietary supplement industry “is opposed to regulations.” That is absolute nonsense! The dietary supplement industry has long supported new laws and regulations that are reasonable, with these already in place: all vitamin companies must follow FDA-audited Good Manufacturing Practices requiring safety and identity testing, only FDA-approved ingredients can be used, steroid precursors are banned, and companies must disclose all complaints of adverse events requiring medical attention to the FDA within 15 days. The dietary supplement industry supports increased government authority to mandate product recalls in the Food Safety Bill. But the American people won’t stand for a major expansion of government power that gives bureaucrats absolute veto authority over each new consumer product, stifling innovation. That’s not only anti-capitalism, it’s un-American.

Original story
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100629/SPORTS/6290316/-1/SPORTS

This reply published:
http://www.recordonline.com/apps/pbcs.dll/article?AID=/20100709/OPINION/7090312

Reference:
http://multimedia.olympic.org/pdf/en_report_324.pdf

Boston Globe wrong on Vitamins, Supplements

Dietary Supplements Are Regulated In its Nov. 2 editorial, the Globe complained that the FDA is “powerless” to police dietary supplements and called for a repeal of the Dietary Supplement Health and Education Act of 1994. Health and Education Act of 1994. I suggest that the editors read the law and see what it is that they would lose by doing so. Mandatory Good Manufacturing Practices (GMP) were authorized by this law. GMPs control the manufacturing of all supplements, requiring quality controls, identity and safety testing. Federal GMPs are currently being implemented. No one in their right mind wants this to go away right when it is just getting started. Federal pre-approval of all new dietary ingredients (NDIs) is also required by DSHEA. Isn’t that close to what the editors suggest when they want pre-market approval of all new supplements? Adulterated products are already banned by this law. And steroids and steroid precursors are specifically banned under another more recent law that was supported by the dietary supplement industry. DSHEA bans misbranded products, such as those containing hidden drugs, and offers them absolutely no protection. In fact, the misbranded products that the editors complained about are actually defined as unlabeled drugs by the FDA, not as dietary supplements, so technically DSHEA does not even apply to them. Let’s leave out the evildoers who deliberately hide illegal drugs in bottles misbranded as dietary supplements. What does that leave us with? The vast majority of dietary supplement companies responsibly follow the law and do not have poor quality products. There are rarely cases of serious injuries or deaths from dietary supplements when you take away the products that are really illegal drugs made by outlaws who don’t care about the law or their own customers’ health. Responsible brands follow the new FDA dietary supplement GMPs, checking all ingredients for identity and purity and looking for contaminants and known adulterants. They truthfully declare all ingredients and correct dosages on the labels. They monitor product usage for adverse events and report serious ones to the FDA when they occur. They are not the criminals counterfeiting illegal drugs disguised as dietary supplements. What part of this cries out for such severe regulation that pre-market approval of new formulas is needed? How will new laws stop lawbreakers when their actions are already clearly illegal? Pre-market approval in Canada is a joke; many ingredients and formulas are not available there even though American citizens freely enjoy their use without serious issues. Some American manufacturers have already pulled out of the Canadian market, while others offer only small selections of their lines because of the bureaucratic hoop jumping required for government approval. If DSHEA is repealed, many safe legal products providing much-needed nutrients will disappear while the lawbreakers continue to do business, with a net harm to public health. http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/02/police_these_pills_and_powders/

More about steroids and DSHEA

The fact that CNN removed the video and corrected its text report on DSHEA by substituting some of the original quotes with quotes from US regulatory agencies adequately confirms that my original criticism was both factual and confirmable. Make no mistake; it is currently illegal - under DSHEA - to put undeclared ingredients like steroids and steroid precursors in a dietary supplement. The fact that some outlaws have made supplements containing illegal drugs - without declaring them on their labels - is not a reflection on the legally operating dietary supplement industry; any more than a drug smuggler hiding contraband in a teddy bear is representative of all teddy bear manufacturers or a hollowed-out book is representative of all publishers. My contention is that steroids are often being deliberately and illegally added to “spike” certain dietary supplements, which are not "contaminated" in the sense that the substance was not accidently added. The addition of an undeclared active ingredient is "adulteration" under DSHEA, whether deliberate or accidental, and adulteration is quite clearly illegal. The FDA has full power to remove adulterated substances from the market under DSHEA and other laws; there is absolutely no legal protection for these unlawful “supplements”. It’s not a law’s fault if a government regulatory agency fails to vigorously enforce it, despite having clear authority in that area to act. Yet that’s precisely the kind of misdirected criticism that some critics of the industry propose: blaming weak enforcement on a perceived legal emasculation which simply isn’t there. This, despite the fact that the dietary supplement industry’s legislative allies have introduced bills to add funding to the FDA specifically so the agency could enforce DSHEA more strictly; which is additional proof that the industry does not avoid reasonable regulation and in fact prefers it to false claims of being “unregulated”. The Dietary Supplement and Nonprescription Drug Consumer Protection Act now requires all serious adverse events to be reported to the FDA within 15 business days. The supplement industry also supported this Act, knowing that it had to prove the safety of its products and show responsibility to the public and to lawmakers. The fact that supplement manufacturers supported the Anabolic Steroid Control Act of 2004 (HR 3886), banning androstene-type substances, should also reflect favorably on their commitment to responsible regulation and a desire to protect the public health. Even that has not quieted some critics. It is precisely an industry revulsion to outlaws posing as legitimate manufacturers that has repeatedly prompted industry support for additional government regulation. Industries do not typically request more regulation, so this stance should be more notable. Still, in my opinion it is illogical to blame a law for the actions of outlaws. Outlaws fill a perceived need at a high price, just like other drug dealers, but to consider their products to be accidentally “contaminated” is naïve, at best. Under authority granted to it by DSHEA, and after years of industry prodding, the FDA has only recently rolled out mandatory current good manufacturing practices (cGMPs), requiring safety and identity testing. There are a number of manufacturers already certified as operating under independently certified GMPs, giving consumers a high assurance against inadvertent contamination. Steroids and anabolic steroid precursors are currently regulated as prescription drugs. So no dietary supplement manufacturer has any legitimate, legal reason to use these controlled substances in any of their products, whether on or off the label, making accidental contamination quite implausible. The FDA has not claimed that DSHEA blocked its ability to regulate dietary supplements. Actually, several FDA commissioners have testified to Congress that they already had adequate enforcement powers under DSHEA; and that was before the introduction of additional regulation such as cGMPs, adverse event reporting, the anabolic steroid precursor ban, etc. It is irresponsible to continue to echo allegations that have already been disproved, taking on faith the word of cheaters who have been revealed and are trying to point the blame elsewhere. It’s ludicrous to try to shift blame on a law passed some 13 years ago, a law that specifically prohibits adulterated products. I think that the baseball player’s union leader successfully did just that, knowing that he had a receptive audience in a leading DSHEA critic. But the resulting publicity, repeating the tired old complaint of supplements being “unregulated”, does not constitute any form of real evidence, flying in the face of so many contrary facts. If you are still in doubt, don’t take my word for it. Please read the various pieces of legislation or check the websites of the regulating agencies and see for yourself. I have done both and base my writings solely on these demonstrable facts and reputable references, including official government agencies.

The China Syndrome: Where do your vitamins come from?

The China Syndrome: Where do your vitamins come from? By Neil E. Levin, CCN, DANLA A large number of people have been recently asking whether dietary supplement ingredients come from China, with the implication that everything from China is dangerous and adulterated. Some have been misinformed, being told that most supplements originate in China and that there may be some reason to worry about them. These people are scared and some even promise to stop buying any product made in China. How valid is this fear? While it is true that much of the domestic vitamin C supply comes from China, that is not true for most ingredients in American dietary supplements. And, believe me, American vitamin manufacturers have long been wary about buying cheap, generic ingredients from China. It has taken a lot of time and successful testing of materials for Chinese ingredients such as vitamin C to eventually penetrate the American market. Some Chinese suppliers have demonstrated a dedication and history of quality manufacturing, which in turn has established a measure of confidence in their American and European customers. These are not a few “bad apples” that are trying to sell substandard ingredients to us. These are the tried and true good guys that have a devotion to quality. Why punish them for the mistakes and misdeeds of Chinese pet food manufacturers? Guilt by association has never been my favorite prejudice. In fact, the Natural Products Association (NPA) has inaugurated a new Chinese affiliate organization, with the express purpose of establishing pre-testing and certification of select Chinese dietary supplement ingredients before they are shipped to the US. This is yet another measure intended to protect the American public by testing and screening raw materials intended for the US market. Joint ventures with European and Japanese manufacturers has recently placed brand new, state-of-the-art pharmaceutical-grade production facilities in China that meet the same exacting standards as US, European or Japanese plants that have long been associated with the highest quality ingredients. These new plants are registered with the FDA and meet current good manufacturing practices for pharmaceuticals (cGMP), with some facilities also registered as ISO compliant and kosher certified. These are not shady operations, and in some cases exceed the quality standards of older Western facilities. You could walk through them and feel like you were in a top pharmaceutical plant in Switzerland. The best US manufacturers, those who have earned the coveted GMP certification for good manufacturing practices, have quality control programs in place to evaluate both suppliers and ingredients. Testing provides a means to ensure that both vendors and ingredients are identified and approved before use. In the case of vitamin C, testing to assure that the material meets strict US standards of quality and identity for pure L-ascorbic acid is a key control point, with the material typically meeting pharmaceutical monographs for purity standards. Microbiological screening is another quality measure employed by some US manufacturers to assure safety in plant and animal derived ingredients. And some manufacturers actually help to advance the science of quality by publishing validated test methods in peer-reviewed scientific journals. These new methods include recent publications for advancing the testing of unadulterated glucosamine and chondroitin. I have a fear that the enemies of dietary supplement use and American health freedom have irresponsibly cooked up this campaign of fear to swamp US supplement companies with requests for country-of-origin information for every ingredient and to waste both their and their customers’ time chasing a red herring. As we have seen no indication of any specific problem with dietary supplements (other than television pundits apparently trying to morph legitimate pet food fears into unfounded fears of possibly tainted supplements), someone is obviously riling up American consumers in an effort to create doubts about the safe use of vitamins. Who stands to gain from this fear-mongering? The news media obviously thrives on sensational reports that make us question everyday conveniences. The medical/pharmaceutical complex is another obvious beneficiary of people being afraid to use vitamins. Self-appointed consumer advocates think that they can reduce risks by getting people to avoid “unproven” and “unregulated” natural products and therapies, hoping to get them to use “safe” medical therapies instead. These folks have failed to read the annual reports of the American Associations of Poison Control Centers, which prove that even lip balms and household cleaners are more deadly than vitamins. Don’t be fooled by reports of vague dangers from Chinese ingredients used in American dietary supplements sold by large, reputable US manufacturers. Until there is some basis in fact, I regard this as strictly a cynical attack by enemies of natural products, intended to erode our resolve to making better health choices, including the use of dietary supplements. If we fear to take our supplements, we will abandon them and be left with drugs as our only means to correct health problems amplified by nutritional deficiencies, often caused or aggravated by by our poor diets. And since over 90% of Americans fail to eat even the minimal RDA levels of nutrients, that means you!