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The Healthy Lawyer: The Vitamin Conundrum

The grocery and drugstore shelves seem to be overflowing with every imaginable type of dietary supplement.  Dietary supplements include vitamins, minerals, herbs, and botanicals.  Over half of American adults take multivitamins, and dietary supplements are an almost $30 billion industry.  It is therefore no wonder there are so many types of vitamins and supplements, from multivitamins to fish oil, and an equally wide array of brands. With countless options available, I know I have gotten overwhelmed and frustrated.  Your health care provider is the best person to offer guidance regarding which particular vitamins and supplements would be most beneficial for you, but even armed with that knowledge, it is difficult to know what to look for when selecting a supplement.

Regulation of the Dietary Supplement Industry

Regulation of the supplement industry in the United States falls under the authority of the Food and Drug Administration (FDA). On the FDA website, the information on dietary supplements is listed under the “Food” tab, not the “Drug” tab.  The applicable law is the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under this law, the FDA’s role generally does not begin until after a product is on the market.  Similar to the sale of cosmetics, which I wrote about here, the government does not have much, if any, role in approving dietary supplement products before they are sold to consumers.

Myths About Dietary Supplements

Even after products are placed on the market, the FDA’s role is limited. Here are some common myths many consumers may have about dietary supplements and the government’s regulation of them.

Myth #1: The FDA tests the safety of dietary supplements before they are sold to consumers.

The FDA does not test the safety of dietary supplements before they are placed on the market, and does not require any sort of pre-market approval before supplements are sold to consumers.  Safety testing is the responsibility of the             dietary supplement manufacturers and distributors.

Myth #2: The FDA tests the efficacy of dietary supplements before they are sold to consumers.

Likewise, the FDA does not test dietary supplements to see whether they are actually effective.  It is up to the supplement manufacturers and distributors to test their products for efficacy.

Myth #3: The FDA can remove products from store shelves they suspect are unsafe.

Mere suspicion is not enough; the FDA has no power to remove a product from a store shelf unless it can actually prove the product is unsafe.

Myth #4: The makers of dietary supplements must share and disclose safety information about their products with consumers and the FDA.

Supplement manufacturers and distributors are under no obligation to share their findings on the safety or benefits of their products with the FDA or the public.

Myth #5: Federal law requires manufacturers and sellers of dietary supplements prove the accuracy and truthfulness of claims stated on product labels.

There is no requirement that claims made on dietary supplements be proved to the FDA’s satisfaction as being accurate or truthful before they are sold.  They are required, however, not to be false or misleading.

What Does The FDA Do?

Since the FDA generally deals with products after they have entered the market, it usually only takes action after something bad has happened.  The FDA will intervene in cases of emergencies– remember those ephedra containing weight loss pills from a few years back?  In that case, the FDA eventually banned dietary supplements in 2004 that contained ephedra, which was associated with adverse effects such as heart attack, stroke, and even death.

The second instance in which the FDA states it will step in is when a product is unsafe or fraudulent or in violation of the law. Routine monitoring of products comes in third on the list of FDA priorities when it comes to dietary supplement regulation.

Non-Governmental Industry Watchdogs

Since many believe there is inadequate government oversight of the supplement industry, public interest groups like Consumer Labs and the Center for Science in the Public Interest (CSPI) have become industry watchdogs.

CSPI was ready to initiate litigation against Pfizer for deceptive advertising relating to its well-known Centrum brand of vitamins.  In a recent settlement agreement, Pfizer agreed to remove statements on its Centrum multivitamins that claimed to prevent breast and colon cancer.

Information To Consider When Choosing A Dietary Supplement

Given that it is up to the consumer to educate herself about the risks and benefits of dietary supplements, below are some tips to keep in mind when choosing a supplement.

Quality of Ingredients

There is a large range in quality and price when it comes to the different brands of dietary supplements.  It would seem that a supplement such as Calcium, for example, would contain, well, Calcium.  While this is true, many supplements also often have added ingredients that either do not add any nutritional value or are actually harmful.  It is not uncommon to find preservatives, fillers and even contaminants in dietary supplements.  Sometimes fish oil supplements have contaminants such as mercury and PCBs.

Consumers wishing to limit the number of chemical additives in their supplements may chose to opt for vitamins that are sourced from whole foods rather than those that are primarily synthetically derived.  There are also vitamins available that are “non-GMO,” or made without genetically modified organisms.

Dosage

There is no requirement that a supplement contain a specified amount of a nutrient. For example, one brand may have twice the amount of a specific nutrient as another brand. It is therefore possible one serving size has either more than or not enough of a particular nutrient your body needs. The FDA states that, “[o]ther than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.”

Although it may not seem like a big deal to get more than the recommended daily allowance for a particular vitamin or mineral, it is possible that large doses of an individual nutrient taken over a long period of time may do more harm than good.  Recent studies have shown that too much calcium can lead to calcium plaques and an associated risk of heart attack.  Fortunately, in addition to information you can get from your doctor or other health care provider, the government provides guidelines on upper intake levels for vitamins.  The upper limit “is the maximum daily intake unlikely to result in adverse health effects.” 

Third-Party Certifications

Since it is difficult to identify these unwanted ingredients without the proper scientific or nutritional background, consumers can turn to third party certification of dietary supplements.  These independent, not-for-profit organizations will test for such things as contaminants, and verify good manufacturing practices related to consistency and accuracy.

     USP (U.S. Pharmacopeial Convention)

     NSF International

     Natural Products Association

FDA Resources

The FDA website also has some useful information and tips for consumers:

     Recently Issues Warning Letters to Manufacturers and Distributors

     FDA Dietary Supplement Alerts and Safety Information

     Tips for the Savvy Supplement User

It is better to get your nutrients and vitamins from foods, but all of us may want a little boost every now and then through the aid of a dietary supplement. With all the research taking place now and the promotion of trendier vitamins like resveratrol and bee pollen, it is also exciting to consider the benefits such supplements can provide health conscious consumers.  Armed with the knowledge that it is up to you to be an informed and educated consumer, you can empower yourself to make smart and beneficial supplement choices.

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