FDA Issues Dietary Supplement Rules

While the FDA sets rules for purity and safety, effectiveness remains unclear.

June 22, 2007 — -- The U.S. Food and Drug Administration announced Friday that manufacturers of vitamins, herbal pills and other dietary supplements would have to test the ingredients of all their products for safety and purity.

The new standards follow concerns that existing regulations are too weak in that they allow supplements on the market that were contaminated or whose ingredients didn't match claims made on the label.

But while the rules may strengthen enforcement in these areas, some experts say that the real question is the effectiveness of these products.

"This final rule establishes industrywide standards," said Robert Brackett, director of the center for food safety and applied nutrition at the FDA, in a press conference this morning. "Consumers should have increased confidence that the dietary products that they purchase are safe."

Published in an 800-plus page report, the regulations set so-called good manufacturing processes for the 29,000 dietary supplement products currently on the market -- including vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements.

The supplement makers will have to test the ingredients of all their products for purity, and accurately report ingredients on their labels.

Before his, supplements fell under the same regulatory guidelines used for food. But according to the FDA, regulating supplements in this way missed some critical problems.

"[The final rule] tries to be more specific about regulating the processes used to make diet supplements, which are quite different from the way you process food," said Vasilios Frankos, division director of the office of dietary supplements at the FDA.

The requirements also apply to imported supplements manufactured outside the U.S. Enforcement of the new guidelines begins Aug. 24.

"The aim is to prevent the wrong ingredients getting into supplements," said Frankos. The regulations also try to prevent contamination of supplements as well as the accidental inclusion of pesticides, glass or heavy metals like lead.

Fable-Free Labels

"These new regulations will at least take the quality issue off the table," says Dr. Brent Bauer, director of the complementary and integrative medicine program at the Mayo Clinic. "If a patient wants to try ginseng, they can be assured that when they purchase a ginseng brand that claims to have 5 percent ginsenosides, they will know that is what they are getting."

But what happens when a company doesn't deliver what it promises?

In these situations, the FDA would issue a warning to the company, asking it to correct the problem. The next step would be a mandatory order to pull the product off shelves, possibly accompanied by a fine.

The FDA is leaving much of the enforcement of the new regulations to supplement manufacturers themselves, a $21.4 billion industry. It has recently become law for the supplement industry to report serious health problems associated with their products to the FDA.

"The ruling is appropriate, but it will just be a paper tiger if there is no FDA staff to monitor things," says Keith Ayoob, associate professor of pediatrics at Albert Einstein College of Medicine. "The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements. … If they get caught, they'll just fold up shop and reopen under another name."

Even with the new regulations, if they are enforced, supplements still have fewer controls than drugs -- an important health consideration for the 150 million Americans who take these products.

"Most people don't realize that dietary supplements can have side effects, just as there are potential side effects to prescribed medications," says Dr. Nieca Goldberg, medical director of the New York University women's heart program. "Because they are chemicals that are added to your body, I think they should be subjected to the same rigorous evaluation as prescription pharmaceuticals."

A drug that the FDA suspects is unsafe can be removed from the market until the manufacturer demonstrates its safety. However, for diet supplements, the onus is on the FDA to prove a product is unsafe before it can be pulled from shelves.

In 2005, after reports of more than 155 deaths were linked to the dietary supplement ephedra, the FDA prohibited its sale. Some experts think that the FDA reacts too slowly when it comes to the safety.

"In many countries -- Germany, in particular -- nutrient supplements are regulated like drugs," says Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. "The U.S. has lagged behind in that area."

Questions of Effectiveness Remain

Though most experts agree that the regulations will increase the likelihood that supplements will be of high quality, some raise the issue of whether these products -- which claim to remedy everything from decreased sex drive to damaged joints -- actually work.

"Nothing here deals with the question of efficacy, which is a shame," said Dr. Jerry Avorn, chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital. "Knowing you have pure and well-made useless crap is a little better than having impure useless crap, but not by much."

Some doctors have been sending their patients to Web sites like www.consumerlab.com to determine if a supplement is of reliable quality.

"It would be as if you could learn about car safety through a Consumer Reports subscription, but there were no federal standards for auto safety," said Yale's Katz.

"We really need both -- for cars, and supplements," he said. "For cars, we have both -- but for supplements, until now, we have not. The new FDA ruling narrows the gap."