John Oliver's take on "Unregulated" Dietary Supplements

Another salvo in the War on Vitamins and Dietary Supplements:

John Oliver was funny, but not remotely fair or accurate. Some of the more grievous false examples (in my opinion):

• He assumed no new laws or regulations have been implemented since DSHEA (the Dietary Supplement Health & Education Act of 1994)
o Untrue, and some have been championed by industry; some examples:
 The 2002 Anti-Bioterrorism law's food safety regulations
 The implementation of mandatory Good Manufacturing Practices regulations and increasing numbers of FDA audits over the past 4 years
 Bans on steroids and their precursors
 A mandatory Adverse Event Reporting law
 The more recent Food Safety Law

• He showed old news reports speculating that the botanical ephedra killed 155 people, asserting that these deaths occurred because of DSHEA tying FDA’s hands
o FDA was admittedly unable to substantiate any deaths
o FDA was able to ban ephedra under DSHEA anyway based on a solely theoretical one death per year from billions of doses taken, despite two FDA expert panels unable to validate any deaths

• He claimed that FDA and FTC are powerless to act because of DSHEA, Hatch and Harkin
o The number of enforcements have been rapidly increasing
 Warning letters, recalls, even seizures
o The number of FDA inspections has been rapidly increasing

• He showed how many citizens supported DSHEA in 1993-1994, but asserted that they were misled by industry champions Senators Hatch and Harkin, who received donations from the then relatively tiny $2 billion industry
o He implied that Hatch and Harkin did it solely for the money
o He implied that Hatch and Harkin still block all regulation; see above for contrary examples
 some of the more recent laws were supported by industry and even sponsored by Hatch and/or Harkin)

• He assumed that dietary supplements are largely unregulated because of not enough regulation, rather than their relatively good safety record versus drugs or even other foods
o He promoted pre-market approval of products and claims, similar to a failed Canadian strategy that cut product selection without enhancing safety
o He cited DNA testing of botanicals failing 1/3 of products tested, without mentioning that this is actually a proposed but not yet validated assay technology disputed by herbal authorities as far too premature to use as a standard

This does not address his criticisms of Dr. Oz, who can defend himself.

Link to show:
http://theweek.com/speedreads/index/263585/speedreads-john-oliver-steps-on-dr-oz-to-savagely-trample-the-dietary-supplement-industry

Most vitamin studies are flawed by poor methodology

In a new published analysis, researchers at the Linus Pauling Institute of Oregon State University report that many large clinical trials of vitamin supplements, especially antioxidants like vitamin C, have flawed methodologies that make them 'useless' in determining the real value of such nutrients.

It is on the basis of such flawed studies created by researchers that are uninformed as to the nature of nutrients that their studies may conclude that vitamins are of no value or may even be harmful.

Of course, common sense tells us that essential nutrients cannot be inherently useless or harmful in reasonable doses, but those are messages that we repeatedly hear in the media reports.  Such flawed science leads to the equally flawed calls for vitamins to be regulated as drugs, adding a new logical error in failing to consider the vast difference in safety between nutrients and drugs.

Drugs are typically synthetic, isolated substances that are foreign to the body and don't act like nutrients, and it is this foreignness of drug properties that make them inherently toxic to the body. That toxicity is the legal basis of regulating drugs as controlled substances, and the failure to demonstrate toxicity of nutrients, except in studies with such flawed methodogies as we are discussing, makes calls to regulate vitamins as drugs hollow and illogical.

A report on that article:
http://www.nutraingredients.com/Research/Most-vitamin-studies-are-flawed-by-poor-methodology-say-Linus-Pauling-researchers

The original peer-reviewed publication in a peer-reviewed nutrition journal:
http://www.mdpi.com/2072-6643/5/12/5161

Sufficient Regulation of Supplements

Critics claim that dietary supplements are under-regulated, which is arguably inaccurate. Critics suggest that the FDA should have the power to ban synthetic analogues of botanical ingredients even when there is no credible safety issue, a major expansion of government authority. There are disturbing attempts to expand the role of unelected government bureaucrats as censors of nature-identical ingredients, even those with a history of safe use.

The FDA recently reinterpreted a 1994 law requiring pre-market notification of New Dietary Ingredients (NDI) unknown to the marketplace or our food supply. The law grants it authority over novel ingredients, not products, by requiring notification, rather than pre-approval. Now the agency is promoting a radical vision by prematurely enforcing its widely criticized Revised NDI Guidance that violates the letter and spirit of the law. FDA asserts the unilateral power to change from requiring pre-market notification of a new ingredient to a de facto registration giving it virtual veto power over all products containing that ingredient. Under its new interpretation, any change of processing or source (i.e. synthetic botanical) gives the FDA power to reject an ingredient even when indistinguishable from one in the food chain.

FDA lacks not only legal authority, but resources to screen thousands of products explicitly regulated as a food category with a presumption of safety. The FDA rejects most pre-market notifications of new ingredients; slowing introduction of new dietary supplements to the marketplace.

Industry critics ignore how dietary supplement regulation has evolved. Mandatory Good Manufacturing Practices (GMPs) are being vigorously audited/enforced by FDA, requiring identity, potency, and safety testing plus rigorous procedure documentation. All serious adverse events must be reported to the FDA within 15 business days. GMP audits and NDI notifications represent pre-market monitoring; AERs post-market surveillance. The Food Safety Bill enhanced FDA’s recall authority. This regulatory regime is so successful that for years there have been no deaths from dietary supplements reported to Poison Control Centers. Current laws work. We don’t need a virtual government takeover of the dietary supplement industry under the pretense of safety.

NYT Hatchet Job on Senator Hatch

Re: “Support Is Mutual for Senator and Utah Industry” (The Champions, June 20, New York Times)

The article presented an inaccurate impression regarding the nutritional supplement industry. Despite heavy costs, manufacturers supported federal regulations creating more rules/enforcement to enhance accountability and public safety. A 1994 law (DSHEA) regulating the dietary supplement industry allows only FDA-approved ingredients and scientifically-supported claims relating to healthy body structures and functions; besides FDA-approved claims.

Additional regulations supported by industry: DSHEA’s mandatory Good Manufacturing Practices (GMP) requiring safety and identity testing, steroids and their precursors are banned; manufacturers must promptly disclose adverse events requiring medical attention; mandatory safety recall authority.  

Senator McCain’s proposed dietary supplement regulation would have subjected each new product introduction to prior FDA approval, expanding the federal bureaucracy with a government takeover of the industry. Importing this Canadian-style regulatory scheme would duplicate that system’s failures: half as many products available; some considered safe in the USA are banned; long waits for variations of existing products; higher prices.

Fortunately, the American people rejected giving government bureaucrats veto authority over all new nutritional products, which already must use preapproved ingredients. We view this as anti-capitalism and un-American.

Neil E. Levin, CCN, DANLA

Clinical Nutritionist

HonestNutrition.com

re:

http://www.nytimes.com/2011/06/21/us/politics/21hatch.html?_r=2&pagewanted=all

My report on regulation of health claims

On April 24, 2010, I was asked as a representative of the American Nutrition Association to participate in a panel discussion at the annual conference in Chicago called Health Journalism 2010, held by the Association of Health Care Journalists. The panelists presented short statements and slides, then answered audience questions. This is a link to my report and slides from that event:

http://americannutritionassociation.org/newsletter/assessing-claims-functional-foods-nutritional-supplements

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

Still Fighting to Protect Our Access to Vitamins!

Over the last week or two, a joint House-Senate conference committee has been considering ways to reconcile two competing federal Wall Street reform bills and turn them into a single bill that both chambers can support. The US House’s Wall Street Reform and Consumer Protection Act of 2009 (HR.4173) and the US Senate’s Restoring American Financial Stability Act of 2010 (S.3217) differ in cost and content, most notably for us in that the Senate version does not give the broad new regulatory powers to the Federal Trade Commission (FTC) that the House version would. By removing limits on its power that are enshrined in current laws, the FTC could impose harsh new requirements on all businesses, even those completely unrelated to Wall Street, banking, or the financial sector; including NOW Foods and other food and dietary supplement manufacturers.

How do we expect that the FTC would act if given such new power? The agency has indicated that it wants to impose stricter standards on any advertising of dietary supplements. Past consent decrees that settled disputes with supplement companies have required strong disclaimers and much more evidence to support any future promotional claims. Consumer advocate organizations have urged the agency to require that multiple clinical trails be done on any advertised product, not just on its ingredients, to support advertising claims. However, such trials take many months, are very expensive, and are not required by current law allowing claims to be based on the body of science backing the active ingredients in a product. If the FTC and anti-business consumer advocates have their way, label claims and advertising will be far more restricted than is presently allowed. Of course, ads already have to be truthful and not misleading, so that’s not really an issue. But the FTC still wants more power so it can unilaterally impose a new regulatory scheme that bypasses today’s requirements for hearings, public comments, and due process before it can change the rules that we operate under.

Do you support another government takeover of an American industry? But this time, for an industry that is not hurting or asking for federal bailouts? One whose products are overwhelmingly proven in the real world to be safe and that helps Americans to maintain good health? Do you believe in freedom of speech for commercial interests like vitamin makers, as long as their ads continue to be honest and not misleading? If so, we are fighting to be protected from a big federal power grab.

Take action now to tell your Senators and Representative in Congress that you want to continue to impose Congress’ reasonable limits on the FTC, rather than expanding its powers. Go to http://www.csofh.org/ to learn how to Take Action and express your concerns!

Following is a list of the people on the joint Congressional committee deciding how the bill will be reconciled. They have the most immediate say on how the reconciled bill will read. However, all Senators and representatives will be asked to vote on the final reconciled bill, so it doesn't hurt to ask them to tell the negotiators to pull the FTC provision out of the bill even if they're not on the joint committee!

House of Representative members on Conference Committee: Frank (D-Massachusetts); Kanjorski (D-Pennsylvania); Waters (D California); Maloney (D-New York), Gutierrez (D-Illinois); Watt (D-North Carolina); Meeks (D-New York); Moore (D-Kansas); Kilroy (D-Ohio) and Peters (D-Michigan); Bachus (R-Alabama); Barton (R-Texas); Graves (R-Missouri); Issa (D-California); Lucas (R- Oklahoma); Smith (R-Texas); Royce (R-California); Biggert (R-Illinois); Capito (R-West Virginia); Hensarling (R-Texas) and Garrett (R-New Jersey).


Senate conferees: Dodd (D-Connecticut); Shelby (R-Alabama); Johnson (D-South Dakota); Reed (D-Rhode Island); Schumer (D-New York); Corker (R-Tennessee); Crapo (R-Idaho); and Gregg (R-New Hampshire). Also appointed as negotiators are Senators Lincoln (D-Arkansas); Chambliss (R-Georgia); Leahy (D-Vermont); and Harkin (D-Iowa).

Vitamins Are FDA-Regulated

Contrary to popular myth and The Healthy Skeptic (LA Times 3/1/10), the federal FDA (Food and Drug Administration) already regulates dietary supplements such as vitamins, minerals and herbs. These are NOT “unregulated” products. What actually makes critics’ teeth grind is the fact that vitamin formulas do not need specific pre-approval from the federal regulators, which is the true endgame of many skeptics. But all ingredients used in nutritional supplements before mid-October of 1994 are already pre-approved by the FDA under an often-misrepresented law called DSHEA, which also requires all new dietary ingredients to be submitted to the FDA for pre-market review before a product is sold. This gives the agency a chance to review the required submission of safety and efficacy data before any new ingredient can be sold, and the power to veto its introduction.

Dietary supplement manufacturers are already required to submit label claims along with scientific documentation to the FDA, but are paradoxically required to use a label disclaimer that the agency has not evaluated the formula. Vitamin makers are already registered with the government, are already prohibited from making medical/drug claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings. Under DSHEA, the FDA can regulate the manufacture of all dietary supplements, an oversight that was dramatically improved over the past 3 years with the rollout of mandatory Good Manufacturing Practices. Obviously, this is not an “unregulated” industry, even if enforcement can be improved in some areas.

Advocates of pre-approval of dietary supplement formulas want to import a highly flawed and controversial Canadian health care program in a misguided effort to give our own unelected government bureaucrats absolute power over already-regulated vitamin products. Many Canadians now cross the border to buy American supplements because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all of the required safety and efficacy documentation. This is not a free market model, does not work well, and is not worth copying.

A permanent government takeover will strangle a preventive health industry that, in America’s free market, has added jobs and exports during our recent recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding; and probably decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. There is a complex regulatory structure for vitamins and other dietary supplements in the U.S. that is working quite well; there were ZERO deaths officially reported from these products last year even though about 2/3 of Americans use them. Claims that “vitamins are unregulated” are woefully inaccurate and should not be published by news outlets with competent fact checkers.

http://www.latimes.com/features/health/la-he-0301-skeptic-20100301,0,2486837.story

My response to Bill O’Reilly’s program “Suzanne Somers' 'No Spin' on Vitamins”

,On Friday, February 19, 2010, Bill O’Reilly discussed recent legislation introduced by Arizona Senator John McCain (the Dietary Supplement Safety Act; S.3002) to impose new regulations on dietary supplements (vitamins, etc.) with Suzanne Somers. He made several points that are quite reasonable: that there should be warnings on labels, that we should know what is in the products, that manufacturers should be registered with the FDA, that ingredients should be disclosed, and that the FDA should have recall authority. I heartily agree with these common sense statements but need to point out that these elements are already mandated by current federal regulations that simply may be inadequately enforced. As in other fields, a few shady operators ignore laws when profits can be made by cheating. The answer to the occasional scofflaw is strict enforcement of existing law; without enforcement, both current and new laws would be equally worthless. But Mr. McCain’s proposed new law will severely decimate law-abiding companies in a misguided effort to import an unpopular regulatory scheme from Canada that gives unelected government bureaucrats absolute power over already-regulated vitamin products. Canadians now cross the border to buy American vitamins because their own government arbitrarily delays entry of new products for years at a time, miserly approving only 42% of products that have been submitted with all the required safety and efficacy documentation. Current laws can accomplish Mr. O’Reilly’s goals, if they are enforced. Dietary supplement manufacturers are already registered with the government, are already required to submit label claims to the FDA, are already prohibited from making medical claims for dietary supplements, and are already required to identity-test and list all ingredients on product labels. Ingredients that have been on the market for many years are already pre-approved by the FDA and all new ingredients must be specially pre-approved before going to market. All mislabeled products are considered adulterated and subject to mandatory recall. A recent adverse event reporting law promptly lets the FDA know of virtually any problem requiring medical attention in order to trigger recalls and new label warnings, This does not sound like an unregulated industry, even if enforcement can be improved in some areas. What we don’t want is the FDA, an agency that is cozy with pharmaceutical interests, to have complete power over every new vitamin formula that is merely a variation of already-approved ingredients. That kind of permanent government takeover will strangle an important health industry that in a free market added jobs and exports during the recession. Vitamins help Americans meet basic nutritional needs in a cost-effective manner without government funding and may have actually decreased some Medicare spending, according to the conclusions of authoritative Lewin Group reports. Understand and enforce the current laws before proposing a virtual federal takeover of an industry that is law-abiding, has welcomed recent regulations that have empowered federal authority over it, and would suffer great harm from a huge increase in unnecessary government interference. Think about it: If you were driving on the highway at 55 miles per hour and occasionally some jerk speeds by at 90, would dropping the speed limit to 45 correct the problem? Of course not. It obviously makes more sense to station additional cops along that stretch of highway to enforce current traffic laws than to collectively punish all drivers. Why is enforcement of vitamin laws any different? Target the outlaws, not the innocent! Neil E. Levin, CCN, DANLA www.honestnutrition.com

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/

Second Opinion on Herbs

Second Opinion on Herbs In a recent opinion, physician Henry I. Miller advocates a new way to regulate dietary supplements (DS), arguing that they are currently unregulated. Although a onetime FDA official and longtime industry critic, Dr. Miller seems out of touch with the current state of DS regulation, including recent major advances in quality assurance by manufacturers. His bias against natural products is made evident by his use of the slur “snake-oil” to dismiss herbal products as simultaneously ineffective and “dangerous”. Many observers, including FDA commissioners during congressional testimony, have testified that the agency has all of the authority it needs to regulate DS. Recent advances include the FDA’s current imposition of mandatory Good Manufacturing Practices (GMP), which was authorized by a 1994 law (DSHEA) that Dr. Miller inexplicitly claims exempted DS from government oversight. That same law stipulates that supplements must not be mislabeled or adulterated and the FDA has repeatedly taken action against such products, again proving Dr. Miller wrong. Manufacturers are now required to have procedures in place to assure product identity, potency and safety, as authorized by a law that Dr. Miller misrepresents. DS manufacturers supported a serious adverse event reporting (AER) law to track patterns of serious side effects. In the first year, the number of DS reports was significantly less than the FDA had predicted. An AER is casually linked to, but not proven to be caused by, a product. Dr. Miller’s assertion that foods and DS like herbs interfere with drugs (Miller’s ‘“real” medicines’) is telling. Is it professional bias to claim that foods, herbs and vitamins are unnecessary nuisances that are interfering with all-important medical treatment? In fact, these legendary interactions appear to be a minor issue. When the Mayo Clinic did a large patient survey to scientifically assess the risk, it reported that there were few such interactions, none serious, limited to only a handful of drug types and a few supplements such as garlic. Dr. Miller’s proposal for a new voluntary oversight entity for herbal products to correct a supposed lack of regulation is illogical; such entities already exist, and how could a voluntary program replace adequate regulation? His seeming ignorance of the current regulatory status of herbs is troubling, undercutting his rationale for such tinkering. Statistically, dietary supplements are safer than drugs and even safer than eating a meal, as recent AER reports prove. DS labeling and manufacturing are currently well-regulated. I suggest that studying drug-nutrient-herb interactions and addressing these on drug labels – where they belong - is a far wiser strategy than creating a “voluntary oversight” entity for dietary supplements, especially as there are already voluntarily GMP-certified brands available.

The Relative Safety of Natural Products

Some have stated that the dietary supplement industry is largely “unregulated”. My response: This is not really a fair statement considering that recent regulatory efforts – supported by that same industry – have clamped down on the industry’s freedom to operate outside the regulatory system. Drug and dietary supplement regulation are becoming more and more similar, though the safety records of the two types of products are remarkably distinct. The dietary supplement industry is now largely regulated, with more and more regulations closing the gaps. Indeed, the industry strongly supported the law to ban steroid precursors from being sold as dietary supplements, making all such products illegal drugs. And the 2006 passage of a law to require all serious adverse events to be reported to MedWatch within 3 weeks – now in effect - is an appropriate method of monitoring safety and determining problem areas needing increased monitoring or official action; though we should not confuse raw AERs with actual evidence of causes-and-effects. The implementation of the long-delayed current good manufacturing practices (cGMP) regulations (that were actually authorized by the oft-maligned DSHEA law in 1994) now requires all supplement manufacturers to be cGMP compliant over the next two years, but with the largest manufacturers required to follow that standard no later than this coming June (2008). cGMP regulations are forcing manufacturers to have quality controls on raw materials and finished goods throughout the manufacturing process, including identity and safety testing. The FDA already prohibits all adulterated products, and has in fact used its authority to act against known offenders, as noted by the agency itself. 2. There are claims that “the Institute of Medicine and the Food and Drug Administration have found that supplement health claims are largely unsupported”. My response: The FDA clearly regulates supplement label claims and requires manufacturers to submit all label claims and maintain proper documentation. The agency apparently does not review this information unless there is a problem; meanwhile making manufacturers submit such information to it while requiring a contradictory label disclaimer that the FDA has not reviewed the claims. I guess that’s what’s called “plausible deniability”. However, the vast majority of responsible manufacturers are careful to present adequate documentation to the FDA, and the cGMP regulations require well-documented justification of all processes, including the writing of label claims. DSHEA requires preapproval of all new dietary supplement ingredients with an eye to proving safety, though manufacturers are allowed to use existing ingredients if they first submit their new label claims to the agency. All new drugs need pre-approval, as do all new supplement ingredients, but drugs are approved for specific uses (though often used for other unapproved “off label” conditions) while supplements are not allowed to make any disease claims, with very few exceptions for FDA-approved health claims. (http://www.cfsan.fda.gov/~dms/supplmnt.html) 3. Some physicians warn that “supplement use can be associated with death”. My response: Supplements, foods and drugs are all associated with death risks, with supplements statistically being the safest of them all, by far. Some have chosen to focus on a very few cases of dietary supplements possibly linked to deaths, but other readers have mentioned the very large death toll from both properly prescribed drugs and drug errors as a way to counter the thinking that drugs are somehow more tightly regulated, and thus presumably safer, than dietary supplements. I agree. In the annals of our peer-reviewed literature, dietary supplements are rarely responsible for accidental deaths other than by illegal adulteration, making this class of products far safer than less-regulated foods or even more regulated drugs. And, just as in the case of prescription drugs, the FDA does not test for purity and safety. Regulators routinely require industries to have quality controls in place to do such testing themselves, with penalties for non-compliant products that come to the attention of the regulatory agencies. And it is appropriate that regulators focus on the products with the most potential to cause injuries, illnesses and deaths. The routine collection of serious AERs will serve to focus the regulators on problem areas. (For more discussion and literature citations, see #6 below.) 4. There are claims that “We cannot easily know” what’s really in supplements. My response: cGMP manufacturers must test their ingredients, so responsible manufacturers do not allow the use of adulterated ingredients and have means to avoid them. It is likely that the adulterant in this case was deliberately added to ensure a noticeable effect. By definition, an adulterated supplement actually becomes an unlabeled illegal drug, not a dietary supplement. There are already penalties for such adulteration under current regulations, and the FDA has forcefully removed these products from the market. The solution is for cautious consumers to purchase their dietary supplements from responsible brands that have third-party quality certifications, and it is likely that only those individuals seeking foolish shortcuts will be involved with mail order brands of questionable integrity. The vast majority of supplement manufacturers wish to promote natural health and will not risk their companies on such questionable unlawful schemes. 5. Regarding the relative use of pharmaceutical drugs (OTC and prescription) versus dietary supplements, related to a comment that fewer people use supplements and that explains their apparently greater safety compared with drugs: My response: A recent survey reports that, “43 percent of Americans say they take a daily multi-vitamin for cancer protection. 21 percent take some other form of nutritional or dietary supplement.” (http://www.icrsurvey.com/Study.aspx?f=Supplement_survey_release.html) This indicates that a majority of Americans, about 2/3, take dietary supplements. In the case of prescription drugs, about 45% of Americans take a prescription, with the percentage rising sharply with age. (http://www.cdc.gov/nchs/fastats/drugs.htm) And Americans also take non-prescription OTC drugs, with a combined rate of drug use estimated at about 2/3 of all Americans...about the same percentage of the population as uses dietary supplements. So the argument that the use rates are sharply different is not substantiated by the data, meaning that the dramatically lower death and adverse event rates for dietary supplements are indeed a valid testimony to their relative safety versus drugs. 6. Some have commented that just because something is "natural" doesn't mean it's safe. My response: There are no foods or dietary supplements that are unregulated by the FDA, and most natural products are far safer than artificial ones. Most synthetic substances, including drugs, have a far greater risk of side effects and deaths in the clinical literature. Still, we make choices every day and do not stop consuming most foods, drugs or supplements because most have such a tremendous reward-to-risk ratio. We obviously can’t stop eating. And since our diets are known to be deficient in essential nutrients, dietary supplements do have an important role to play in ensuring adequate nutrition. (Nutrition and Your Health: Dietary Guidelines for Americans. USDA. 2005. also Fairfield KM, Fletcher RH. Vitamins for chronic disease prevention in adults: scientific review. JAMA. 2002 Jun 19;287(23):3116-26. Review. Erratum in: JAMA 2002 Oct 9;288(14):1720. PMID: 12069675) It was reported in JAMA that, “Most people do not consume an optimal amount of all vitamins by diet alone. Pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements.” (Fairfield KM, Fletcher RH. Vitamins for Chronic Disease Prevention in Adults: clinical applications. JAMA. 2002;287:3127-3129.) Regarding food safety, a medical journal report concluded that, “We estimate that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year.” (Mead PS, et al. Food-related illness and death in the United States. Emerg Infect Dis. 1999 Sep-Oct;5(5):607-25. Review. PMID: 10511517). This indicates that eating food is a far riskier activity than taking dietary supplements, since the risk for the 2/3 of food eaters that are also supplement takers is literally orders of magnitude lower than 2/3 of the known risk of eating food (which everyone does). There are few human activities with lower odds of causing death or serious illness than taking dietary supplements. In fact, even lipsticks and cosmetics are typically responsible for more annual accidental deaths than vitamins. Looking at the categories of deaths reported by the American Association of Poison Control Centers from 2002-2004, only 5 accidental deaths were reported linked to dietary supplements, 7 from cosmetics and personal care items, over 600 related to acetaminophen use, 117 related to aspirin use, and 66 from ordinary household cleaners. By far, dietary supplements are probably the safest category of products that we put into our mouths, and are demonstrably getting safer with the new regulations now being implemented. 7. Let’s talk about the real dangers of drugs, which exceed the risks of supplementation by mind-boggling amounts. That is the main reason why drugs are controlled substances. A JAMA report documented the large death toll for properly prescribed drugs: “We estimated that in 1994 overall 2,216,000 (1,721,000-2,711,000) hospitalized patients had serious ADRs and 106,000 (76,000-137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.” (Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998 Apr 15;279(15):1200-5. PMID: 9555760) Also, the Washington Post reported in its 7/21/06 edition on an Institute of Medicine study released a day earlier on the toll of improperly prescribed drugs: "At least 1.5 million Americans are sickened, injured or killed each year by errors in prescribing, dispensing and taking medications, the influential Institute of Medicine concluded in a major report released yesterday. Mistakes in giving drugs are so prevalent in hospitals that, on average, a patient will be subjected to a medication error each day he or she occupies a hospital bed, the report by a panel of experts said. Following up on its influential 2000 report on medical errors of all kinds, the institute, a branch of the National Academies, undertook the most extensive study ever of medication errors in response to a request made by Congress in 2003 when it passed the Medicare Modernization Act. The report found errors to be not only harmful and widespread, but very costly as well. The extra expense of treating drug-related injuries occurring in hospitals alone was estimated conservatively to be $3.5 billion a year." Prescription drugs were named as one of the largest causes of American deaths, perhaps the second largest, as noted in another report by CDC, also published in JAMA: "IN 2004, POISONING WAS SECOND ONLY to motor-vehicle rashes as a cause of death from unintentional injury in the United States. Nearly all poisoning deaths in the United States are attributed to drugs, and most drug poisonings result from the abuse of prescription and illegal drugs. Previous reports have indicated a substantial increase in unintentional poisoning mortality during the 1980s and 1990s. To further examine this trend, CDC analyzed the most current data from the National Vital Statistics System. This report summarizes the results of that analysis, which determined that poisoning mortality rates in the United States increased each year from 1999 to 2004, rising 62.5% during the 5-year period." (FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION: Unintentional Poisoning Deaths—United States, 1999-2004. JAMA, March 28, 2007; 297: 1309 - 1311.) As you see, the fuss about dietary supplement safety is in reality a tempest in a teapot, as the risks of eating normal foods and using pharmaceuticals are each far more dangerous, in turn. This is not to minimize the need for strict controls of dietary supplements…but to a large degree, these controls already exist or are currently being implemented. Enforcement has been slowly tightening over the past 15 years. But, looking at these authoritative death and injury statistics, is anyone really surprised that the FDA properly chooses to focus its enforcement actions on products that are proven to be dramatically more dangerous to public health than dietary supplements? Some form of triage is appropriate, given the large number of deaths and injuries from food and drugs. But dietary supplements generally do not significantly contribute to these risks, and therefore do not deserve to be singled out as especially dangerous when they are comparatively very safe. Neil E. Levin, CCN, DANLA

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

The FDA has a legal framework for authority over dietary supplement safety and accurate/proper labeling

Senate Bill 1082, passed 93-1 on 5/9/07 SEC. 605. ADULTERATED FOOD REGISTRY. (a) Findings- Congress makes the following findings: (1) In 1994, Congress passed the Dietary Supplement Health and Education Act (P.L. 103-417) to provide the Food and Drug Administration with the legal framework to ensure that dietary supplements are safe and properly labeled foods. (2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act (P.L. 109-462) to establish a mandatory reporting system of serious adverse events for non-prescription drugs and dietary supplements sold and consumed in the United States. (3) The adverse event reporting system created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act will serve as the early warning system for any potential public health issues associated with the use of these food products.