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