Vitamins, protein powders and other products available to consumers have surged since 1994 when the Dietary Supplement Health and Education Act became law and limited federal oversight of a vast and complex industry.
In two decades, supplements on the market have leaped from about 4,000 to an estimated 50,000 to 70,000, according to some estimates.
But with that increase also has come a jump in the number of supplements from dubious sources, some containing potentially harmful — even deadly — ingredients, Food and Drug Administration records show.
Clusters of illnesses and numerous deaths have been attributed to tainted supplements over the years, none more infamous than the thousands of adverse reactions in the early 2000s linked to the dangerous herb ephedra.
Despite a federal ban of ephedra a decade ago, poisons — and problems — continue to dog the supplement industry.
In July, for example, the agency revealed that 29 people, mostly on Long Island, had been sickened by steroid-tainted vitamin capsules. This month in Hawaii, a nationally sold weight-loss supplement was linked to serious liver damage in 29 people, two of whom required liver transplants. Authorities have yet to identify the poison.
Expert: Few barriers to entry
The tainted local capsules were made by Mira Health Products in Farmingdale, a small contract laboratory shuttered last month amid a federal investigation over anabolic steroids.
Contract laboratories have sprung up nationwide, offering manufacturing facilities to virtually anyone interested in staking a claim in the industry. Some openly advertise on the Internet.
“There is virtually no barrier to starting a supplement company and selling vitamins in the United States,” said Dr. Tod Cooperman, founder of ConsumerLab.com in White Plains, a private firm that tests supplements for purity and efficacy.
Numerous commonly sold products have proved problematic when put to rigorous scientific testing, Cooperman has found.
“So it’s a buyer-beware situation,” added Cooperman, a physician and medical scientist. “And now, with the Internet, you don’t need a storefront or distributor.”
Critics of the 1994 law, such as Dr. Arthur Grollman of Stony Brook University School of Medicine, say the industry’s self-policing has allowed scofflaws to proliferate.
“People like me would really like to see DSHEA [the 1994 act] not just revised but dropped entirely,” said Grollman, director of the Laboratory of Chemical Biology.
He doubts that will happen.
“We’re talking about a $30 billion industry that has enough lobbyists to fight anything that vaguely hints at regulation,” added Grollman, an expert in herbal medicine pharmacology.
Steve Mister, chief executive of the Council for Responsible Nutrition, the leading supplement-industry trade organization, calls companies that adulterate products “outliers.”
He said they don’t represent the bulk of vitamin and supplement makers in the United States, which adhere to regulatory guidelines and good manufacturing practices.
In a recent speech, Mister suggested that his industry consider wider use of third-party certification organizations, such as those offering seals of approval.
“If we can’t eliminate the tainted products and the shoddy manufacturers, we can at least make it easier to tell who they are,” he said.
Stronger rules pitched
The 1994 act restricts the FDA from exerting authority over supplements as long as manufacturers make no claims about preventing or treating disease. Yet companies frequently are cited for deceptive promotions.
Grollman supports a bill now on the U.S. Senate floor that would give the FDA more consumer-protection power.
Sens. Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) reintroduced a measure that would help consumers make educated choices by requiring more information on supplement labels. The bill also would give more authority to the FDA, requiring manufacturers to register products.
Multiple supplement companies have been cited by the agency in recent weeks because products were tainted or lacked the potency claimed on the label:
Oct. 11. Flora Essentials, a digestive supplement, was recalled because of possible contamination with the prescription antibiotic chloramphenicol, which is associated with the risk of a rare and potentially fatal blood disorder called aplastic anemia. The product is made in Canada.
Oct. 10. Consumers were warned not to buy several products: Dr. Mao’s Slimming capsules; Perfect Body Solutions; Burn 7; Bella Vi Insane Amp’d, and Bella Vi Amp’d Up, because they contain a banned and dangerous weight-loss medication and an unsafe laxative. There were no addresses for these companies, which sell on Amazon.com and other sites.
Oct. 8. An FDA issued a warning involving the weight loss supplementOxyElite Pro, manufactured by a Texas company, because it’s linked to a cluster of 24 liver-damage cases. The temporarily withdrawn product was sold via the Internet and in retail stores.
Oct. 4. Nature Made, a major vitamin maker, recalled five different brands of its Full Strength Mini Multivitamins because the B1 and B12 components were found to lose potency more rapidly than expected.
Oct. 3. Recall of turmeric, a spice, often used in natural medicine because it contains excessive lead, which can cause mental and physical impairment. The brand, known as PRAN, is a product of OnTime Distribution in Brooklyn.
Oct. 1. A company called Haute Health in New Jersey, which sells in retail outlets and over the Internet, recalled three supplements aimed at men’s health. The FDA found the products contain sildenafil, the active ingredient in Viagra, which can interact with medications, such as nitroglycerin, resulting in dangerously low blood pressure.
Cases involving adulterated products are similar to the investigation of Mira, which has been under FDA scrutiny because vitamins allegedly contained anabolic steroids. The FDA has yet to post a final report on its website.
Mira made vitamins for Purity First Health, which had operated out of an East Northport house and, before that, out of a Deer Park auto repair shop. For about a dozen years, Purity conducted business out of a small building in an industrial section of Farmingdale.
Many of the people sickened by Purity’s vitamins had been patients of Farmingdale chiropractor Terence Dulin, the FDA has said. Prior attempts to contact Dulin were unsuccessful.
The discovery of steroids in Purity’s products led to its closure last month.
The FDA wasn’t the first agency to find problems with Mira-manufactured vitamins — it was New York’s public health laboratory.
Dr. Kenneth Aldous, director of Wadsworth Center’s division of environmental health sciences, said his scientific team initially had no idea what was making people sick. Scientists turned to a highly complex analytic technique — mass spectrometry — which, to their surprise, revealed traces of the potent steroids.
“For us this was unique,” Aldous said of spotting illegal compounds in vitamins.
That discovery of steroids occurred weeks before federal scientists analyzed the samples. Aldous said the FDA later corroborated the state’s findings.
“Typically we are not looking at these types of samples. But globally this is a huge issue,” he said.
How consumers can stay savvy:
1. Check to see whether the manufacturer has received warning letters or has been the subject of recalls or product seizures. This can be done at the Food and Drug Administration’s website, http://www.fda.gov/Safety/Recalls/default.htm
2. Check the scientific literature. Many recent problems in the supplement industry have been studied by researchers who’ve uncovered, for example, that many brands of vitamin D do not contain the amount of active vitamin indicated on the product label. This can be accomplished by searching pubmed.org
3. Question health care practitioners who recommend specific supplement brands. Ask whether there is scientific validation for claims being made about a specific supplement. Also ask whether the practitioner has a financial interest in the recommended company.4. As a general rule: If the claims about a supplement sound too good to be true, such as a brand cures arthritis or some other ailment, then it is wise to be wary.
5. If you don’t mind the expense, you can pay for your own product tests to determine whether a brand contains the ingredients indicated on the label or possesses contaminants.