There’s leutin for eyesight, lycopene for the prostate and fish oil for the heart. There’s even a supplement for chronic pain – magnesium. Millions of Americans take supplements every day to improve their health; from vitamins and minerals to amino acids and bovine hormones. But are these products safe? And are they effective?
The $20 billion dollar dietary supplement industry is regulated by the federal Food and Drug Administration under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Federal regulations for dietary supplements are very different from those for prescription and over-the-counter drugs. For example, a supplement’s manufacturer does not have to prove a product’s safety and effectiveness before it is marketed. Efforts to tighten regulations have brought howls of protest from the supplement industry – and that is the case today as the FDA seeks public comment on its proposed New Dietary Ingredient (NDI) Draft Guidance, which would require manufacturers to submit a “premarket safety notification” whenever they introduce a supplement with a new ingredient.
Opposition to the guidelines is pervasive and vociferous. The industry supported Alliance for Natural Health USA (ANH) contends that up to 30,000 nutritional supplements would be permanently removed from the marketplace if the FDA implements the new rules, costing the industry over $6 billion in sales.
“One thing is certain,” says Gretchen DuBeau, executive and legal director of ANH, “If the FDA adopts its NDI draft guidance, the disastrous impacts will be felt throughout the entire community. Manufacturers, retailers, health practitioners, and consumers will have far fewer choices and far higher costs.”
Daniel Fabricant, PhD, is the man behind the FDA’s proposed guidelines. Before becoming director of the FDA’S Division of Dietary Supplement Programs, Fabricant served as vice president of the Natural Products Association, the largest trade group in the U.S. representing supplement makers and distributors. So it’s noteworthy that he is now at odds with his former constituents.
“My goal is to put a robust safety program into practice,” says Fabricant, who calls consumer safety his number one issue. “The Dietary Supplement Health and Education Act was passed, but there are parts of the law that still need to be fully implemented—like creating a compliance plan for new dietary ingredients and furthering the relatively new ‘good manufacturing practice’ regulation.”
Federal law already requires supplement manufacturers to notify the FDA whenever a product includes an ingredient that was not marketed in the U.S. prior to 1994. Companies must assure the agency “the ingredient is reasonably expected to be safe under the conditions recommended or suggested in the labeling.” Since 1994, the supplement industry has submitted only 700 NDI safety notifications, even though there are 55,600 products on the market and 1,000 new ones introduced every year.
The Alliance for Natural Health takes issue with the use of the term “notification.”
“It is actually an approval process, and the FDA turns down most NDI applications,” the alliance claims on its website. The ANH further contends that even though supplements “are much safer” than drugs (no data is cited) the approval process suggested in the NDI draft guidance makes the scientific standard for new supplements almost the same as the pharmaceutical standard.
“The FDA, which is supposed to guard and promote our health, is hostile to the kind of natural medicine—based on diet, supplements, and exercise—that represents the real future of healthcare,” states the ANH. “The agency has either been captured by drug interests or is trapped in a catastrophically expensive, toxic, and ineffective patented-drug model.”
Critics of the supplement industry say it has good reason to avoid any extra scrutiny from the FDA. Recent research indicates weight loss products alone – a $2.4 billion dollar component of the supplement industry – are largely ineffective.
“For most people, unless you alter your diet and get daily exercise, no supplement is going to have a big impact,” says Melinda Manore, a professor of nutrition and exercise at Oregon State University. Manore reviewed the evidence surrounding hundreds of weight loss supplements and found no evidence that any single product results in significant weight loss. She also found that many supplements had no randomized clinical trials that proved their effectiveness.
“What people want is to lose weight and maintain or increase lean tissue mass,” said Manore. “There is no evidence that any one supplement does this. And some have side effects ranging from the unpleasant, such as bloating and gas, to very serious issues such as strokes and heart problems.”
Manore’s study, which was published online in the International Journal of Sport Nutrition and Exercise Metabolism, found only a few products, including green tea, fiber and low-fat dairy supplements that can have a modest effect on weight loss. None of the supplements work, however, without changes in diet and exercise.