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.

Steroids in Baseball Blamed on Dietary Supplements

1. Say It Ain’t So, Donald Steroids in Baseball Blamed on Dietary Supplements In the latest twist in the baseball players’ steroid use scandal, congressional hearings following the release of the Mitchell Report have generated a new controversy: MLB players union chief Donald Fehr has apparently tried to shift part of the blame to poor regulation of dietary supplements, suggesting that players may have accidentally ingested banned drugs due to poor manufacturing practices in an industry deregulated by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Let me be blunt: What a bunch of bull! First of all, it is ridiculous to try to point the blame at dietary supplements as the cause of professional athletes’ steroid use, implying that the players were doped against their will. I can’t believe for a minute that world-class athletes don’t have their expert trainers carefully scrutinize products before using them, and then only as part of a complete nutritional program. Either the players or their trainers know, or should know, what they’re taking. Does anyone really believe that players are impulsively buying crappy supplements in gas stations? Please! In fact, DSHEA does not allow steroids to be used in dietary supplements. DSHEA actually makes it illegal to sell dietary supplements containing any undisclosed ingredients, making them by definition “adulterated” and subject to strict FDA action. DSHEA also requires that all health claims be submitted to the FDA, and prohibits any new dietary ingredients without first registering safety information with the agency. The Bioterrorism Act also requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA. Please check the FDA website and see it all for yourself. (3) It is plainly illegal to sell any restricted substances - drugs - without OTC status or a physician's prescription, and all drugs require specific labeling. It is also illegal to sell anabolic steroid precursors like androstene in this country because of another law that was strongly supported by the dietary supplement manufacturers. A New York Daily News article (2) uncritically echoed the unbelievable argument that supplements are now unregulated because of DSHEA and reprinted an outrageous quote by someone who should know better, alleging that “DSHEA was created in order to give the supplement manufacturers a huge shield so they could distribute steroids”, despite the obvious restrictions and regulations that the law imposes. Mr. Fehr’s questionable allegations were featured on AOL, CNN, ESPN, and news feeds that went around the world; sometimes with sympathetic journalists adding similar sentiments and supporting quotes. But we can see the facts for ourselves on the FDA’s own website, proving it ain’t so. (1) Dietary supplement manufacturers also supported FDA’s dramatically increased regulation of supplement manufacturing (cGMPs, or current Good Manufacturing Practices); which was authorized by DSHEA, by the way. The industry even supported mandatory reporting of serious adverse events linked (possibly related) to their products, which is now in effect. It is clear by the record that the dietary supplement industry has consistently supported increased regulation of its own operations and products as a good faith effort to protect its customers, an estimated 2/3 of American adults, even though DSHEA has obviously given the FDA additional regulatory authority over a number of areas. The industry has even lobbied Congress for additional FDA funding to improve the agency’s enforcement of dietary supplement regulations, an incredible effort by an industry to increase government regulation of that same industry. This support should come as no surprise, since the industry is focused on the scientific use of nutrition as a means to offer healthy alternatives for people trying to avoid the use of drugs in the first place. Drugs are dangerous controlled substances, by definition, and nutrients are regulated as a special food category. In this case, Rep. Waxman seemed quite willing to believe the hype, but his history evidences his unwavering belief that the dietary supplement industry is under-regulated, even as more and more layers of regulation are added. Could it be that Mr. Fehr simply, and successfully, gambled that he could distract his inquisitor by providing another target that might be welcomed by such a prominent industry critic? In my opinion, this whole baseball doping controversy really has nothing to do with sloppy supplement manufacturing or poor regulation of the dietary supplement industry, which I consider slanderously false accusations, and everything to do with deliberate illegal drug dealing and steroid use by those who are now desperately trying to find a scapegoat. 1. http://www.cfsan.fda.gov/~dms/ds-ind.html 2. http://www.nydailynews.com/sports/baseball/2008/01/16/2008-01-16_donald_fehr_admits_mlb_players_union_res.html?page=0 3. http://www.cfsan.fda.gov/~dms/supplmnt.html

Consumer Reports Wrong on Dietary Supplements

CR Wrong on Dietary Supplements By Neil E. Levin, CCN, DANLA Consumer Reports published an article on dietary supplements in January 2008, titled, “Risky Pills – Supplements to avoid”. Unfortunately, CR may have failed to live up to its reputation as an impartial arbiter of quality, apparently relying on its medical and research consultants’ opinions instead of actually testing products. How informed and impartial are these sources on this particular topic? Of course, there is no excuse for companies that blatantly break the law by illegally and knowingly adulterating dietary supplements with drugs or banned substances. The dietary supplement industry asks the FDA and FTC to throw the book at those bad apples pretending to be legitimate businesses. In fact, manufacturers overwhelmingly supported recent legislation – now the law of the land – to put teeth into FDA enforcement powers by banning steroid precursors, regulating manufacturing requirements (cGMPs, current good manufacturing practices) and instituting mandatory reporting of serious adverse events. The supposed burden on the FDA “to prove that a supplement creates “a significant or unreasonable risk” before it can demand its removal” is actually a very low bar, now that the US Supreme Court has allowed a ban on the herb Ephedra without requiring proof that the agency had followed the law, or even its own regulations, in the process. In the CR report, several dietary supplements are singled out for criticism, but with some startling omissions of fact. Androstenedione products (anabolic steroid precursors) have already been outlawed, with the explicit support of the dietary supplement industry. Only rogue manufacturers carry them because they are clearly illegal. Chaparral is mentioned as a present danger, but reputable manufacturers voluntarily withdrew the herb after an FDA warning – back in 1992. Organ and glandular tissues are singled out for risk of Mad Cow disease, but only certain ones are vulnerable and these have largely disappeared from the marketplace. Most glandular tissues are carefully obtained from range-fed animals in New Zealand or Argentina, from areas with no reported cases of this disease. The alkaloid synephrine from Bitter Orange (Citrus aurantium) often gets accused of causing “high blood pressure, heart arrhythmias, heart attack, stroke”. Yet the FDA Medwatch program’s web page does not list a single substantiated complaint of the herb causing these symptoms. Most Bitter Orange is used in formulations along with caffeine and other legal stimulants. In fact, there is evidence that Bitter Orange is not responsible for some of these products’ side effects: “Ephedra-free weight loss supplements have significant cardiovascular stimulant actions, similar to ephedra. These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine … had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation.” (The American Journal of Medicine (2005) 118, 998-1003). In 2004, attorney Marc Ullman requested FDA records on Bitter Orange adverse events from the FDA under the Freedom of Information Act. Scrutinizing these files, he found that many so-called adverse events supposedly related to Bitter Orange were actually for unrelated products, combination formulas, pre-existing conditions etc; reporting that, “In its response to the April 14 FOIA, FDA disclosed it had conducted no research whatsoever concerning either the safety or efficacy of Citrus aurantium.” (Natural Products Insider) The American Herbal Products Association also reviewed every adverse event report on Bitter Orange disclosed under another FOIA request and, after eliminating products also containing ephedra and/or caffeine, found only one minor adverse event (weakness, leg swelling) remaining in the FDA archives, which involved a woman also being medicated for osteoarthritis, hypertension, and diabetes. (HerbalGram. 2006;69:52-55) Another study reported that, looking at formulations including Bitter Orange and caffeine with other herbs, “Laboratory testing (including vital signs, serum chemistries, CBC with differential, urinalysis, and electrocardiography) revealed no significant changes.” (Curr. Ther. Res., 60, 145 - 153.) And in another report, “Bitter orange dried-fruit extract did not significantly alter the [heart rate] or blood pressure after a single dose was administered.” (Pharmacotherapy, Dec. 2005) Yet another study reported that bitter orange had no significant effects on any of the cardiovascular variables measured. (Journal of Clinical Pharmacology, 2001;41:1059-63) Another small study reported small increases in these measures, but the point is that strong cautions are premature, at best. One expert has stated that synephrine works differently if synthesized or injected, rather than orally taking the natural herbal extract. (Experimental Biology and Medicine (vol. 229) and Washington Post 9/7/05). There is still reasonable doubt that Bitter Orange supplements have caused any serious adverse events. The herb kava is also the subject of a caution. I personally use this herb, and have looked at the few, unverified reports relating to liver problems and concluded that they are anecdotal and probably unrelated to use of the herb. Some toxicology experts note that the vast majority of such reports are unverified and that “kava extracts continue to demonstrate a far better risk-to-benefit ratio [than medical options].” (Toxicology Letters, Volume 150, Issue 1, 15 April 2004) My routine liver function tests remain optimal. I was surprised that CR touts the “USP Verified” mark, a certification that is not even as stringent and broad-based as the new federal cGMPs, which are mandatory. This explicit endorsement of a commercial testing program that does not yet meet the new national standard seems misplaced, and is also unfair to imply that GMP-certified manufacturers audited by competing certifying agencies have lesser quality controls. I believe that CR has missed the mark in portraying dietary supplements as dangerous and unregulated by using inconclusive, outdated and unrepresentative data. Why doesn’t the magazine to raise its coverage of these issues to the same high standard as its other reporting? Scaring consumers into using more dangerous medical treatments by such methods may sell magazines and gain media exposure, but at the cost of CR’s credibility, consumers’ wallets and real lives lost. Reactions to properly prescribed pharmaceutical drugs reportedly cause over 100,000 deaths per year and may be the fourth leading cause of death in the US; even ignoring medical errors and overdoses. (JAMA, Apr 1998; 279: 1200 - 1205.) Positioning herbs and other dietary supplements as dangerous, when they are rarely life-threatening, is irresponsible and completely disproportional to their relative safety.

Natural Health: Ten Predictions for the Year 2008

Natural Health: Ten Predictions for the Year 2008 By Neil E. Levin, CCN, DANLA 12/10/2007 The New Year will bring more proof of antioxidant benefits for human health. Recent research shows that antioxidants help to maintain healthy brain functions during aging, protect brain and nerve cells, and prevent hormones and cholesterol fractions from oxidizing to become more harmful forms. Look for an expanded understanding of the benefits of these synergistic nutrients in 2008. 2008 will provide more proof of omega-3 fatty acids’ benefits. For example, DHA helps to maintain healthy balances of cholesterol fractions and protects the brain and nerves. EPA helps normalize cell membranes and cellular health. These essential fats are typically very low in the American diet, so dramatic results could occur in clinical trials providing these nutrients to participants. There will be more safety scares regarding popular prescription and Over-The-Counter drugs, creating new safety warnings and label cautions. Since the most popular medications are typically blocking or inhibiting natural body functions (calcium channel blockers, cholesterol production inhibitors, serotonin re-uptake inhibitors, stomach acid production inhibitors, etc.) rather than dealing holistically with the causes of problems that create body imbalances (lack of optimal levels of nutrients, environmental chemicals and metals, chronic stress - lack of deep sleep, low fiber - high carbohydrate diets, etc.), major side effects from such drugs are inevitable. Side effects from pain medications will become more evident, increasing the number of people looking for safer alternatives. Herbs and spices are the major natural alternatives with some scientific evidence of efficacy. The market for organic and local foods will continue to grow at amazing levels. This will put pressure on the regulatory, farm and grocery industries to manage these products and segregate them to maintain their integrity. That contrasts with the increased reliance on genetically engineered corn to produce ethanol that raises food costs and increases the use of farm chemicals. And there is much evidence that non-genetically engineered foods are both environmentally and nutritionally superior to their modified cousins, while natural farming techniques are proving superior to chemical and genetically engineered farming in terms of managing fuel and seed costs, water use, improving both crop yields and selling prices, etc. Millions of farmers around the world have already weaned themselves from the chemical-genetic “green revolution” to use appropriate local farming techniques and have actually been more successful as a direct result of truly “green” practices. America has begun to awaken to the benefits of local and organic foods in terms of freshness, reducing the use of fossil fuels for transportation and demonstrable benefits to local economies. Watch for these trends to accelerate in 2008. Blood pressure and blood sugar concerns will continue to grow, along with a medical backlash attacking natural strategies to manage these concerns. However, science will also continue to amass evidencing the positive health benefits of natural products to help people maintain already healthy blood levels, in contrast with the poor symptom management that is a characteristic of pharmaceutical or surgical interventions used to “correct” chronic biological imbalances. These issues dovetail with current obesity and cardiovascular concerns and are part of the same syndrome related to chronic stress and poor diets. Positive reports of the benefits of higher levels of vitamin D will continue to proliferate, though with some bias against the synthesized vegetarian/vegan form of vitamin D2 versus D3 from fish oil or sheep lanolin. Health authorities will be pressured to raise both the recommended Daily Value and the Upper Limit of vitamin D to five times the current levels. Research will continue to accumulate regarding the health benefits of whole grains and whole foods, as will reports of people allergic or sensitive to gluten, corn, and other grains. More mainstream processed groceries will have whole food options in 2008. This is a good trend, though with cautions for the sensitive minority. There will be continuing claims that “dietary supplements” are illegally contaminated with steroids or other pharmaceutical drugs. These claims will typically be self-serving and defensive, made primarily by athletes accused of cheating by using banned substances. Beyond the obvious fact that legitimate supplement manufacturers do not have illegal substances on hand and that GMP (Good Manufacturing Practices certification) quality manufacturing protocols would avoid inadvertent contamination, these accusations are a barometer of how “unregulated” the mainstream media and the public thinks dietary supplements are. While there are plenty of regulations written specifically to regulate supplements, and even the FDA claims that it has adequate regulatory authority, somehow certain medical authorities and journalists like to pretend otherwise; perhaps to have a handy punching bag to deflect attention from the well-documented hundreds of thousands of deaths caused annually from pharmaceuticals and medical errors. In any case, expect more of this blame game in 2008. With a presidential election campaign under full swing, no meaningful legislation regarding health care or Medicare will be passed in 2008. There will be a narrow window of opportunity for such measures in 2009 with a new Congress and Administration. Natural health advocates will continue to press for meaningful use of nutrition to combat the major causes of disease and illness in America, with probably little impact against the lobbying might of the medical and pharmaceutical interests. The wild card is if, by some miracle, the insurance industry finally notices that their costs could be contained by the use of targeted nutrition such as the use of calcium and vitamin D to prevent osteoporosis, antioxidants to prevent age-related macular degeneration and oxidative-related glaucoma that affect vision and impact seniors’ independence, omega-3 fats to prevent coronary heart disease, the use of fiber to manage healthy cholesterol levels, etc. That could swing the pendulum towards the use of natural products to control healthcare costs. But I’m not betting on it happening in 2008, though I hope that they wise up soon enough to manage the recently overactive increases in medical costs. There will be additional, unjustified health scares about essential nutrients in 2008. Especially beware of “meta-analyses” that mix unrelated studies and magnify the number of variables using often-flawed statistical models. Some probable targets: · Kava (a few unrelated, anecdotal reports of liver problems) · Folic acid (a few reports of higher cancer levels despite a lot of cellular data indicating the opposite, creating a backlash against re-fortification of refined foods) · Vitamin E (continued championing/publicity of questionable meta-analyses over more rigorous blood-level studies will continue the inexplicable controversy over the safety of this essential nutrient that most Americans are reportedly deficient in.) · Beta-Carotene (again, blood level studies and total antioxidant studies repeatedly show its safety, but studies measuring only administration of certain doses to sick populations that may be deficient in antioxidants create a conflicting picture.) · DHEA (this adrenal hormone has been vilified as a “steroid”, but is no more so than vitamin D. No less an authority than physician and US Senator Tom Coburn has sent a letter to his colleagues informing them that he has reviewed the issues and urging them to avoid a ban of this natural product, which is useful in anti-aging strategies but not for bodybuilders. Efforts by leading senators (including presidential candidates Clinton and McCain) to ban DHEA are ongoing.