Please be careful out there!

The U.S. Food and Drug Administration recently announced that manufacturers of dietary supplements, vitamins, herbals will now have to test their products and ensure that they contain what is claimed on the label and that the ingredients are pure. This announcement probably came as a surprise to many consumers who mistakenly believed that supplements had been being regulated.

The FDA’s recent action was sparked after years of finding supplements adulterated with ingredients such as prescription drugs; to contain lead and other heavy metals, pesticides, glass, bacteria or other contaminants; or not even contain the vitamins or herbals listed on the label at all.

It is imperative for consumers to understand, however, that this new ruling doesn’t address if the supplements are safe and effective for the conditions they claim to remedy. Unlike many countries, such as Germany, supplements here aren’t regulated like drugs. By calling it a dietary supplement, companies don’t have to provide any evidence that their claims are true before they can sell them. Why?

The reason is a law called the Dietary Supplement Health and Education Act. As the FDA explains:

In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

Under DSHEA.... dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products. Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them... the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.

According to Dr. Timothy N. Gorski, M.D., F.A.C.O.G., of the University of North Texas Health Science Center and Board Member of the National Council Against Health Fraud:

[T]he 1994 DSHEA legislation, however well-intended it may have been at the time, is a principal contributor to the problem of fraud in the dietary supplement industry. This assessment has also been made by others, including former FDA Commissioner David Kessler and the editors of The New England Journal of Medicine.

Yet, DSHEA severely limits the FDA’s ability to regulate these products, explained Dr. Stephen Barrett, M.D. in a history of dietary supplement regulations. According to the FDA Center for Food Safety & Applied Nutrition:

The FDA cannot take action against supplements that are worthless or merely suspected of being harmful, as it can — and has — in the case of both prescription and over-the-counter medications. ... the FDA has been unable to remove even dangerous supplements from the marketplace, not even ephedrine products which have injured thousands of people. When enforcement actions are taken, the FDA has no authority to inflict financial penalties, so that perpetrators of fraud bear no net financial cost from their predations. There is not even a requirement that the FDA be notified about the sale of a “dietary supplement" or of the identity and whereabouts of its manufacturer and promoters.

Essentially, the FDA can issue Warning Letters when it finds marketing claims that violate the Federal Food Drug and Cosmetic Act, which bans unapproved claims for products that are intended for curing, mitigating, treating, or preventing of diseases. But, in the vast majority of cases, the supplement companies are making so much money, they simply ignore these letters and continue selling the products, despite the lack of support for their health claims. Unless consumers sift through the FDA product warning letters, they are none the wiser.

When cited for one false health claim, supplement companies will also frequently continue to sell the products using a different claim, and the FDA can hardly keep up with them all. For instance, the FDA concluded in a scientific review and ruling on January 27, 2004 that: “there is no credible evidence to support qualified health claims for green tea consumption and a reduced risk of gastric, lung, colon/rectal, esophageal, pancreatic, ovarian, and combined cancers.” Yet green tea products abound among dietary supplements making endless other claims.

The National Council Against Health Fraud and the Quackwatch network worldwide have followed countless cases for years, which makes them very unpopular with the supplement industry and alternative modality practitioners, as you can imagine. Here is one example documented by Dr. Barrett at Quackwatch:

Joseph Mercola, D.O., who practices in Schaumburg, Illinois, also operates one of the Internet's largest and most popular health information sites. Mercola states that his site has over 50,000 pages and is visited by “millions of people each day" and his three-times-a-week electronic newsletter has over 850,000 subscribers. In 2004, Medical Economics reported that his practice employed 50 people and that he employed 15 people to run his newsletter, including three editors. Many of his articles make unsubstantiated claims and clash with those of leading medical and public health organizations. For example, he opposes immunization and fluoridation, claims that amalgam fillings are toxic, and makes many unsubstantiated recommendations for dietary supplements. Much of his support comes from chiropractors who promote his newsletter from their Web sites.

The FDA ordered Mercola and his Optimal Wellness Center to stop making illegal claims for products sold through his website in a warning letter issued on February 16, 2005, involving his virgin coconut oil, chlorella and “Living Fuel Rx,” and other products. You can read the FDA’s determination of the false or misleading claims here.

The FDA issued a second warning letter on September 21, 2006 after conducting an inspection of his facility and found numerous products being marketed in violation of the Federal Food, Drug, and Cosmetic Act, including chlorella, virgin coconut oil, vitamin K2, and “Cardio Essentials Nattokinase NSK-SD.” You can read the FDA’s letter and review of the false and misleading claims about these products here.

Are these products continuing to be sold? That answer was easy to find. Here, chlorella is listed on Mercola’s online store, with claims that: “chlorella is a nearly perfect nutritional food” that will detoxify the body of impurities, increase concentration, promote a healthy pH balance and freshen breath. On this product page, organic virgin coconut oil is still there, claiming to “help promote weight loss,” support immune system and thyroid function, and is “absorbed deep into the skin to strengthen underlying tissues and help to keep connective tissues strong and supple.”

Another of its online catalog pages lists CardioEssentials Nattokinase NSK-SD, which is said to contain a “powerful enzyme called nattokinase that has produced monumental success for maintaining vein health” and gives a list of other “many remarkable properties” for health beyond the circulatory system. The Vitamin K2 product page is here, calling this vitamin the “Pinnacle of Bone and Heart Health” and the supplement is said to contain menaquinone MK-7.

Mr. Scott J. MacIntire, district director at the FDA, wrote in their last warning letter to Mercola that it “is not intended to be an all-inclusive review of your website and products your firm markets” and reminded the company it was up to them to address all of their products. On the Mercola store are a host of dietary supplement products Mr. MacIntire was no doubt referring to, with such claims as:

Living Seas fücoTHIN — is the answer to jump-starting your weight control program (said to contain fucoxanthin, pomegranate seed oil and carotenoids)

Perfect Cleanse — to purify and remove toxins from the body and detoxify the liver (says it contains a proprietary blend of certified organic fibers to resists fermentation in the gut and the re-release of toxins back into the body)

Radical Fruits — an antioxidant compound to support the body’s defense system needed with “our increased level of stress, environmental pollutants, and fast food diets” (said to contain antioxidants; a proprietary “poten-zyme” to make nutrients more available to the body; and “fruit extracts with alkalizing minerals from hormone-free goat's milk to support your well-being”)

Himalayan Crystal Salt — “known as ‘white gold’ because it contains eons of stored sunlight”... to help you age gracefully, “balance the excess acidity from your cells, particularly your brain,” promote bone and sinus health, and more

Green Tea Extract — with anti-aging properties and ability to neutralize the effects of harmful fats; inhibit bacteria and viruses including HIV, hepatitis, and herpes; protect against oxidation in your brain and liver and promote healthy gums

Whey Healthier — an “immune boosting” protein drink claimed “to promote peak wellness by optimizing proper protein, fats, carbs, and micronutrients

Customers can also take an online “Metabolic Typing Test” that purports to customize nutrition based on your individual body type. Or purchase Ferrite Beans to “protect your brain from deadly cell phone radiation.”

Of course, this is just one dietary supplement marketer. There are countless others that have been cited by the FDA, such as the companies already mentioned selling shark cartilage products. When companies sell supplements that have been associated with especially serious health problems, the FDA will issue a Consumer Advisory, as it did on March 25, 2002 for kava. It cautioned the public that more than 25 reports of serious liver problems to the point of liver failure had been received around the world for kava-containing products. Yet, an investigation by Fox News on May 31, 2006 reported that kava products were still on the market and the FDA had since received nearly 100 reports of adverse reactions involving kava, including deaths.

The Federal Trade Commission (FTC) also gets involved when dietary supplement companies make unsubstantiated health claims in their advertising. In 1995, for instance, it settled with Nature's Bounty, Inc., and its subsidiaries, Puritan's Pride, Inc., and Vitamin World, Inc. for making deceptive claims about a number of its products which the company couldn’t substantiate. The FTC order “prohibits the respondents from making those claims that were challenged in the complaint as false, and requires them to have substantiation for specific health-related representations they make in advertising and promoting any product in the future.”

Testifying on March 9, 2006 before the House Committee on Government Reform, Lee Peeler, Deputy Director of the FTC’s Bureau of Consumer Protection, said:

The FTC has filed fourteen complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams, and patches. Also, in the past year, the Commission obtained orders against forty companies and forty-four individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement, and civil penalties.

Products, such as shark cartilage, continue to be sold, but to help get around advertising restrictions, health claims may be presented indirectly through media stories.

The bottom line is that it really is up to consumers to protect themselves. Skepticism — i.e. critical thinking — isn’t a bad skill to have. Dr. Barrett wrote a helpful consumer guide a few years ago, entitled “The Herbal Minefield.”

The USDA Food and Nutrition Information Center has compiled a General Resource List For Consumers wanting to check out claims about dietary supplements.

And the FDA and FTC developed a Fact Sheet for consumers entitled “‘Miracle’ Health Claims: Add a Dose of Skepticism,” which offers tips on “how to spot false claims” and “avoiding unscrupulous dealers.” It cautions:

[C]onsumers may be spending billions of dollars a year on unproven, fraudulently marketed, often useless health-related products, devices and treatments. Why? Because health fraud trades on false hope....consumers who fall for fraudulent “cure-all" products don't find help or better health. Instead, they find themselves cheated out of their money, their time, and maybe even their health.

This information may soon become more important than ever for consumers in protecting themselves. A coalition of supplement companies calling itself the Dietary Supplement Education Alliance (DSEA) has just announced a new advertising campaign, with $750,000 to be spent on the initial phase. It’s set to launch in October and according to a press release: “This is the signature advertising program the industry needs to encourage consumers to take advantage of the benefits of dietary supplements.” You can read the media release here to learn about the companies and products involved.

© 2007 Sandy Szwarc