New FDA Rules for Vitamins
"I make my children, my wife, my mother-in-law all take vitamins. There's an overwhelming amount of evidence out there about the benefits of supplements," Kamil says from his office in Bohemia. Not only an enthusiast, Kamil is president and chief financial officer of NBTY Inc., the country's largest manufacturer of dietary supplements.
He also is one of an estimated 125 million Americans who take dietary supplements, which include vitamins, minerals, herbs, botanicals and sports nutrition products, according to the Nutrition Business Journal, a research and consulting firm based in Boulder, Colo. They spend more than $22 billion a year on these natural remedies.
Yet consumers still face the challenge of sifting through mountains of research to decide what benefits, if any, these supplements hold. Men who took multivitamins with lycopene to ward off prostate cancer, for example, are now learning that the substance may not play a role in prevention after all.
While health claims made in studies may still be confusing -- or even conflicting -- one aspect of supplement shopping is about to become a little more straightforward. Beginning Friday, large manufacturers will be required to follow new Food and Drug Administration rules to ensure their supplements do not contain contaminants or impurities, and that packages are accurately labeled. Medium- and small-sized manufacturers will have until 2009 and 2010, respectively, to meet the new standards, which also mandate product testing and regulate the handling of raw ingredients and packaging.
Past Problems
In releasing the final rules, called good manufacturing practices, the FDA cited a few cases in which products had been recalled because of contamination by microbes, pesticides or heavy metals or for containing more or less of the dietary ingredients than listed on the labels.
"We've had some instances where there were clear manufacturing failures," says Vasilios Frankos, director of the FDA's division of dietary supplements. He recalls a case where an innocuous herb in a dietary supplement was inadvertently switched with an herb that has serious cardiac side effects. "The two herbs look very similar," he says. Frankos doesn't know if illnesses or injuries resulted from the switch but adds, "Good GMPs can prevent these mix-ups."
The FDA has long regulated the supplement industry and visits manufacturers in the United States and suppliers to the U.S. abroad, including China, to inspect the plants and their record keeping. Under GMPs, the agency has enforcement powers that range from warning letters to seizure of products that don't comply with the new standards.
These manufacturing rules follow the passage of legislation in December that requires manufacturers of dietary supplements and over-the-counter drugs to notify the FDA of adverse reactions to their products. By the end of this year, companies must provide phone numbers for consumers to call to report serious reactions, such as hospitalization, birth defects, disability and surgical intervention. The manufacturers then have 15 days to report the reactions to the FDA, which will then report problems to the public.
The supplement industry and trade groups hail both the good manufacturing practices and the adverse-reactions legislation as ways to bolster consumer confidence in their products.
"What the consumer can begin to expect after the rules are fully implemented and the FDA is enforcing them is that fringe companies who aren't manufacturing to high standards or are out to earn a quick buck won't be around much longer," says Andrew Shao, vice president of scientific and regulatory affairs for the Washington, D.C.-based Council for Responsible Nutrition, the industry's leading trade association.
Long before the FDA regulations, large companies that make name-brand supplements "followed very, very tight standards, very strictly," Shao says. "It's really a minor adjustment for the FDA and major plants."
NBTY's Precautions
Harvey Kamil says nothing will be different at NBTY. "We have adhered to GMPs since we started in business 37 years ago," he says. The company' large quality-assurance department tests all products that enter and leave its six manufacturing plants, Kamil says. Raw ingredients are quarantined until they are tested for quality and purity. Product samples are taken off the production line and tested. And samples of the final products are retained for periodic testing. In May, NBTY recalled three lots of shark-cartilage supplements after its inspectors discovered the pills were contaminated with salmonella, an organism that can cause serious and sometimes fatal infections, especially in people with weakened immune systems. The supplements had passed an initial inspection, so NBTY investigators believe salmonella emerged after the supplements were packaged. The contamination was found as part of the company's routine testing of retained samples, and NBTY immediately alerted the FDA. There were no reports of illness related to the incident. After the recall, NBTY launched an internal audit to avert future outbreaks, and it no longer buys raw ingredients from that shark-cartilage supplier.
People who take shark cartilage believe it improves the health of joints, and some even claim is can be used to treat or cure cancer.
"We would never make those claims," Kamil says, noting that supplement companies are prohibited by law from making claims that are not approved by the FDA. "We can't advertise claims that can't be substantiated." So, for example, a calcium manufacturer can say the mineral increases bone density, which has been proven in research, but it can't claim calcium prevents or reverses osteoporosis.
Though consumers can be more confident about the purity and labeling of supplements under the new rules, they're on their own to investigate the supplements themselves.
Christi Attisani learns about supplements from friends and family, from the Internet and in books. She takes supplements with omega-3 fatty acids to prevent heart disease and improve her memory. Her 13-year-old son takes them, along with other supplements, to treat fibromyalgia, a chronic condition characterized by pain in the muscles, ligaments and tendons, as well as fatigue. Attisani, a 47-year-old social worker who lives in Bay Shore, also takes vitamin C "to give my immune system a boost" and B-12 supplements "to give me an energy boost and help with fatigue."
Regardless of the new manufacturing regulations, Attisani says, consumers need to know about what they take.
"If it's something I'm going to take on a daily basis, I research the heck out of it," she says.
NEW RULES
The FDA is requiring manufacturers of vitamins and other supplements to follow good manufacturing practices, called GMPs, to ensure consumer safety. These rules focus on two areas:
The manufacturing, packaging and storage of dietary supplements to ensure that they are not contaminated with harmful or undesirable substances, such as pesticides, heavy metals or other impurities.
The labeling of supplements to ensure the identity, purity, quality, strength and composition of dietary supplements.
From the August 27, 2007, Prepared Foods e-Flash
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