he dietary supplement industry is booming; surveys show that half to two-thirds of Americans take a supplement regularly. The category includes vitamins, diet aids, herbal products, and other pills, drinks, and powders that claim to promote specific health benefits. Supplements are only loosely regulated; in most cases, the Food and Drug Administration can’t intervene to pull a product from a shelf until after it receives reports that the product has harmed consumers.
We asked experts whether regulations should be tightened.
Pieter Cohen: Lawmakers should step in to ensure supplement safety
Orrin Hatch: Dietary supplement law “a remarkable achievement”
David Seres: Law is “one of the worst frauds”
Steve Mister: Government shouldn’t target herbal supplements
Joshua Sharfstein: “Space for a compromise” to enhance supplement law
By Pieter Cohen: Are the vitamins, minerals, and botanical supplements in our local stores safe? Not according to a landmark study published last month in the New England Journal of Medicine. Researchers with the Centers for Disease Control and Prevention reported that bad reactions to dietary supplements send at least 23,000 Americans to emergency rooms each year and thousands onto hospital wards.
Those shocking numbers should have made the FDA and the supplement industry start exploring steps to improve the safety of supplements. Instead, the FDA has been silent and the industry’s leading trade group, the Council for Responsible Nutrition, declared that the results “reinforce that dietary supplements are safe products” because many consumers aren’t harmed by supplements. This is as if Honda were to reassure regulators that air bags are safe because they usually don’t explode, even though defective air bags have harmed dozens of drivers.
I believe that consumers should have access to a wide variety of supplements, but should also be assured that these products are safe. In the absence of leadership by the FDA and given the supplement industry’s unwillingness to police itself, lawmakers should step in. Here are five reforms of the Dietary Supplement Health and Education Act of 1994 that would accomplish this:
1) Require every supplement to be registered with the FDA. Pills and powders can’t be regulated if it’s not known what is in them. Every supplement should contain a distinct quick response (QR) code linked to a description of what it contains.
2) Require supplement makers to use standard manufacturing processes, as drug companies currently do. This would ensure that consumers purchasing ginkgo or any other botanical ingredient know what they are getting.
3) Eliminate the structure/function loophole. A company must get approval if it claims that echinacea cures the common cold, but doesn’t need approval if it claims that echinacea improves the body’s immune function. Eliminating this loophole would dramatically decrease deceptive advertising practices.
4) Find faster ways to detect dangerous ingredients in supplements before they cause harm. Today, health authorities must wait until a supplement causes injury or death to take a dangerous supplement off the market.
5) Create powerful incentives and tools for the FDA to enforce these manufacturing and safety regulations.
Pieter Cohen, MD, is assistant professor at Harvard Medical School and an internist at the Cambridge Health Alliance. His research specialty is the safety of dietary supplements.
By Orrin Hatch: (The following is excerpted from a speech Senator Orrin Hatch made in October 2014 marking the 20th anniversary of the signing of the Dietary Supplement Health and Education Act).
The DSHEA was a remarkable achievement. The solid compromise legislation has had relatively few problems in two decades, and there has not been a major amendment to its structure in the last 20 years.
DSHEA accomplished a number of things to promote public health.
The law created a crystal-clear definition for dietary supplements and made clear they would be regulated as foods. DSHEA provided the FDA with abundant authority to protect public health through a defined safety standard and new safety authorities.
Instead of assuming all companies are making unsafe products, the law operates on the assumption that most products are safe, and the burden of proof is on the agency to prove otherwise.
That safety authority was subsequently enhanced through a Hatch-Durbin law requiring reporting of serious adverse events, and through recall authority in the Food Safety Modernization Act.
DSHEA also authorized good manufacturing practice guidelines specific to dietary supplements, which were phased in over time – although it shouldn’t have taken 10 years for those guidelines to be implemented.
Orrin Hatch, a Republican, is a senator from Utah. With Representative Bill Richardson (D-New Mexico), he helped create the Dietary Supplement Health and Education Act of 1994.
By David S. Seres: The Dietary Supplement Health and Education Act is one of the worst frauds ever perpetrated on Americans under the guise of protecting their health. It strips the FDA of all but some anemic oversight of products sold as dietary supplements.
The DSHEA allows for wholesale deception. Its rules even provide the wording (e.g. “supports [pick an organ] health”) that lets manufacturers suggest there is benefit from their snake oil without overtly stating it. The only way that dietary supplements are, in fact, regulated is via consumer fraud laws. Nonprofits like Truth In Advertising and the horribly underfunded Federal Trade Commission are the main defense consumers have from the barrage of advertising, often dishonestly presented as expert opinion by practitioners who, unlike requirements in the medical and pharmaceutical industries, have no obligation to disclose their conflicts of interest.
If dietary supplements were only a benign waste of money, this would represent nothing more than a drain on consumers’ wallets. But study after study has shown us that supplements have the potential to harm. The damage often occurs over a long time, so it isn’t obvious to the consumer. Take, for instance, SELECT, a large, randomized trial conducted by the National Cancer Institute to see if vitamin E and selenium prevented prostate cancer. Much to the researchers’ surprise, there was a 17% increase in aggressive prostate cancer among men who took vitamin E. There are many other examples.
In addition, some dietary supplements contain hormones and pharmacologically active substances, and even actual drugs have been slipped into the mix.
The DSHEA should be repealed, and the FDA given the teeth to properly control the huge dietary supplement industry.
David S. Seres, MD, is director of medical nutrition and associate professor of medicine at Columbia University Medical Center, where he directs the medical school’s nutrition curriculum.
By Steve Mister: More than 150 million Americans take dietary supplements each year. They deserve — and often demand — access to high-quality, safe, and beneficial products to maintain and improve their health. The Dietary Supplement Health and Education Act — and subsequent new laws supported by industry — help make that a reality.
Some background: dietary supplements have always been regulated in this country as a category of food, never as drugs, and in 1994, DSHEA reaffirmed that regulatory status. DSHEA actually provided FDA additional authority over supplements and provided new tools for government to enforce the law — tools we wish the FDA would use with greater frequency and resolve.
DSHEA importantly gave consumers assurance that government can’t arbitrarily restrict or remove from the market herbal and nutritional products. However, DSHEA specifically added authority to remove products that are unsafe. The law is clear: what is in the bottle must be accurately listed on the label and vice versa. DSHEA made supplements subject to strict manufacturing regulations and requires that new ingredients must be “noticed” to the FDA.
Because our industry takes consumer safety seriously, in 2006 we urged Congress to adopt new requirements for reporting serious adverse events from consumers, and in 2011 supported Congress in adding facility registration and authority for the FDA to mandate recalls of adulterated products. Our industry is now examining how a product registry could provide added transparency.
The most serious problem facing responsible supplement manufacturers and consumers is criminals selling unapproved drugs illegally marketed as supplements — but that’s not a result of the law, it’s a result of illegal activity. More resources for the FDA, along with the Department of Justice, to prosecute these criminals and exact stricter punishments would go a long way toward solving that problem. New laws wouldn’t deter these lawbreakers.
Laws can be improved upon, but the principles that underlie DSHEA are still valid today.
Steve Mister is president and chief executive officer for the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.
By Joshua Sharfstein: Since its passage in 1994, there have been many calls to scrap the Dietary Supplement Health and Education Act (DSHEA). I believe that there is space for a compromise to enhance DSHEA by strengthening the law’s safety features.
The first step should be to require premarket registration of products, linked to a registry overseen by the FDA. Every container of dietary supplements should have a QR code that, when scanned, verifies the registration and provides information on the product and its contents. It is simply impossible for the FDA to protect consumers from unsafe products as long as the agency has no ability to track what’s on the market. Premarket registration would give the FDA tools to move quickly against unregistered products and stop people with track records of impropriety from scamming or hurting consumers again.
The second step should be to establish laboratory methods to help consumers know what they are buying. Even consumers who do not want the FDA messing with their gingko biloba would like to be sure they are actually purchasing ginkgo biloba.
The third step should be giving the FDA stronger authority to remove unsafe products from the market. While more than four in five consumers believes the agency should be able to act quickly to protect the public, the DSHEA makes it difficult for the agency to act quickly. Prompt FDA action to pull excessively risky ingredients from the market will deter companies from pushing the envelope of chemistry, risking public health.
Increasingly, the dietary supplement industry is realizing that something more needs to be done. Stepwise, basic steps forward on safety that add more tools to DSHEA represent such a realistic path for progress.
Joshua Sharfstein, MD, is associate dean for public health practice and training at Johns Hopkins Bloomberg School of Public Health. He is a former deputy commissioner at the FDA.