March 2005 | Whole Health
I Just Want a Good Supplement!
OK, but you gotta work for it
by Neil E. Levin
You could call Bill Thornton a veteran supplementer. He pops eight dietary supplements a day that include, yes, vitamins and minerals, but also sophisticated heart-healthy amino acids, fish oil and “adaptogenic” herbs. He’s been tweaking this regimen for about a decade, and, at 62, believes it’s been essential to his lack of aches and pains and the vigor to enjoy his work as a specialist briefing doctors on MRI machines.
But despite his confidence in the effectiveness of dietary supplements, Thornton scratches his head a lot about the uneven quality among the thousands of brands that are available. “How do I know, as a consumer, what’s really in the bottle? It’s easy to spend up to $200 a month on supplements,” he says. “But I don’t really know which ones are the best quality.”
Facing store shelves bulging with brand names and labels that span from the basic vitamins to multi-ingredient patented complexes can be daunting. It’s one thing to be the responsible consumer who’s either well informed or follows his practitioner’s recommendation for buying supplements. Yet, once in the store, it’s quite another to tease out which brands have the freshest and purest ingredients—and, importantly, the potency that they claim to have.
With 59 percent of Americans taking supplements everyday, according to a 2003 survey, you can almost hear a choir of perplexed voices joining Thornton’s. With so many choices, how do we determine which are the supplement companies that carry good, quality products?
It’s a Sticky Wicket
To understand why supplement companies are not equally trustworthy, we need to look at how supplements are regulated. Much confusion over dietary supplement quality has to be blamed on the government agency that’s supposed to oversee dietary supplements, the Food and Drug Administration (FDA). The FDA has not come close to utilizing the powers bestowed upon it by the Dietary Supplement Health and Education Act (DSHEA) of 1994 to regulate supplements. “The law has never been fully funded,” William Hubbard, FDA associate commissioner for policy and planning, told Consumer Reports in a story last May. “There’s never been the resources to do all the things the law would command us to do.”
Even these words from the horse’s mouth don’t quell critics who lobby for supplements to be more strictly regulated than some drugs (despite the fact that adverse reactions to “properly prescribed drugs” cause over 100,000 deaths a year). Yet under DSHEA, the FDA’s legal responsibilities include monitoring safety and product information for labeling, claims and package inserts. Moreover, makers of new dietary ingredients (basically those that came on the market after DSHEA was enacted) must show the FDA evidence of the products’ safety before marketing them.
The FDA has begun putting teeth into the DSHEA law that empowers the agency. There are currently dozens of FDA enforcement actions against supplement makers — some of them for touting unproven product health claims, as it’s illegal to say a supplement can cure or treat diseases.
One company selling coral calcium, for instance, was cited for airing infomercials claiming its product could prevent or cure cancer and other diseases. As a result, the company settled last fall, agreeing to discontinue its advertising and paying a $2 million fine. Similarly, the maker of the weight-loss product Metabolife was indicted last July for allegedly lying to the FDA about not disclosing consumer complaints of serious side effects; a trial is pending.
Additionally, the FDA is also moving on composing regulations for “good manufacturing practices” (GMPs). These GMPs, that some insiders say could be issued by late spring, will likely guarantee that what’s in a dietary supplement is pure and the strength and potency of the supplements reflect what’s stated on the label. Inspections of manufacturing facilities will be required and standards met for training, cleanliness, equipment maintenance, record keeping and raw materials. Even though DSHEA gave the FDA authority to impose these standards on supplements in 1994, it’s taken more than 10 years for the agency to get them off the ground.
Living Up To Standards (Maybe)
Meantime, supplement companies have, essentially, been left on their own to provide standards and assurances to consumers, giving the false impression that there is no governance over the supplement industry. Many — perhaps the majority — of supplement companies operate with integrity, yet there are those that attempt to hoodwink consumers and take advantage of the gap in regulatory control that the FDA is now beginning to fill.
In an effort to police its own, the supplement industry has implemented various certification programs but, since there’s no legal FDA mandate yet, the programs are voluntary. Supplement manufacturers can opt to pay to undergo independent third-party GMPs inspections of their facilities or the often-costly analysis of their “finished” products — the contents in the bottles we see on store shelves.
You can check supplement packaging for certification seals, some will carry them, but many do not since these certifications are meant for industry types — for example, a natural foods retailer may look for third-party stamps of approval when buying from various supplement manufacturers and suppliers. Ironically, even though these programs are ultimately to instill consumer confidence, the consumer is left out of the information loop. Nonetheless, lists of companies that are certified for GMPs or ingredient integrity are listed on various websites that are listed at the end of this story.
ConsumerLab, a private company, is the only one that caters directly to consumers, offering selective product testing for a subscription fee. However, recently a major industry group, Council for Responsible Nutrition, filed a complaint with the Federal Trade Association alleging Consumerlab is engaged in unfair and deceptive business practices, saying it “intimidates manufacturers to pay for its services.” Consumerlab, contesting the complaint filed in January, calls it “false and defamatory.”
Dietary supplements — when taken in an intelligent and responsible manner — are clearly a boost to good health. Americans enjoy an unprecedented access to supplements thanks to DSHEA passed unanimously by Congress — much of that credited to millions of consumers weighing in on their right to purchase supplements without excessive regulation. Nonetheless, until the FDA fully exercises the power that DSHEA gave it to oversee the supplement industry, both new and veteran supplementers need to pay close attention.
Neil E. Levin is a certified clinical nutritionist who works in the dietary supplement industry. He is president of Nutrition for Optimal Health Association (www.nutrition4health.org).
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