Which Herb Helps What? Labels Can Now Say

Consumers who painstakingly troll drugstore shelves for just the right vitamin, herb or mineral will soon have some help, courtesy of the federal government.

A controversial new ruling by the U.S. Food and Drug Administration will allow dietary supplement companies to provide more detailed descriptions of the health conditions for which their products are best suited.

Instead of trying to remember whether it’s ginkgo, ginger or ginseng that may help alleviate nausea, consumers can find the information on the product labels or marketing materials.

Whether the move will help or hurt consumers depends on whom you ask. The dietary supplement industry and its supporters say the law will allow consumers to have the information they need to make intelligent choices.

Critics of the FDA’s action contend the ruling weakens protections for consumers by allowing the industry to make more sweeping health claims for its products. They warn that the change will give the public an unwarranted level of trust in herbal and other products that often have not been proved to be pure, safe or effective.

“I’m surprised. I would have thought that the FDA would have taken the opposite direction and cracked down,” said Mark A. Kantor, a spokesman for the Institute of Food Technologists, a Chicago-based professional organization for nutrition experts.

Previously, Tougher Rules Were Proposed

Indeed, almost two years ago, the FDA proposed tougher rules for the health claims that could be included on dietary supplements. While several medical organizations and consumer groups supported the recommendation, the dietary supplement industry and many individual consumers demanded more latitude on health claims, said Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, an advocacy organization for the herb industry.

The rules are “good news,” he said. “Consumers clearly want some information that gives them some clue as to what the benefits [of a product] are.”

In the past, manufacturers have been able to make truthful claims about the effect of a supplement on the body’s structure or function. For example, a product can be said to “help maintain healthy cholesterol levels” or “support the immune system.” Prohibited are disease-related claims such as: “Helps prevent coronary disease.”

The new ruling allows supplement companies to make additional claims regarding common, minor symptoms and conditions that the FDA describes as “associated with life stages,” such as adolescence, pregnancy, menopause and aging.

Manufacturers can now claim, for instance, that a product alleviates PMS symptoms, hot flashes, acne related to adolescence or memory loss related to aging.

As in the past, the FDA rules still prohibit natural-product companies from claiming that their product can treat or prevent a disease. But the agency just gave manufacturers some wiggle room by allowing them to place names or pictures on their labels that relate to a specific disease. A product could, for example, carry a picture of electrocardiogram tracings that might imply the treatment of a heart ailment. Or a product could be called “CircuCure,” which implies a benefit for circulatory problems if supported by scientific evidence.

Judith Dotzel, the FDA’s acting associate commissioner for policy, said the agency’s decision, printed in full in the Jan. 6 Federal Register, was meant to uphold and clarify the original, sweeping law governing dietary supplements, the Dietary Supplement Health and Education Act of 1994, popularly known as DSHEA.

“The purpose of the rule is to try and make it easy for consumers,” she said. “The rule sets out criteria and countless examples.”

But the decision, which will take effect early next month, has stunned doctors and consumer advocates who have been critical of FDA policy on dietary supplements and who fear consumers will be harmed by less government oversight. “Consumers will be confronted with hundreds, perhaps thousands, of products that make claims for serious health conditions,” said Bruce Silverglade of the Center for Science in the Public Interest, a consumer advocacy organization. “These claims won’t have been evaluated by the FDA, so consumers won’t know if they’re true or not.”

Critics of the new rule fear that it will further encourage consumers to “self-diagnose” and “self-medicate” without consulting a doctor about their symptoms, a concern long expressed by medical organizations. At its annual meeting last year, leaders of the American Medical Assn. voted to work with Congress “to modify” DSHEA to require that products undergo FDA approval for evidence of safety and efficacy.

That is not the direction the agency took.

Hard for Public to Weigh Risks and Benefits

“The area of dietary supplements is an area where there is very little research. So it’s hard for the public to weigh their risks and benefits,” said Dr. Yank Coble, an AMA trustee and an endocrinologist in Jacksonville, Fla. “The public has a high level of confidence in food, water and drugs. They will have the same confidence in these claims--which should not be the case.”

The law may also create confusion over what, exactly, is a disease as opposed to a condition, Kantor predicts.

“Who will have the final word on what is a condition and what is a disease? Some dermatologists consider acne to be a disease. It’s caused by an organism. It has symptoms. There are treatments. It seems, to me, it follows a lot of the criteria for disease. And I’m not sure you can compartmentalize some conditions to certain life stages. What about adults who get acne?” he said.

Adds Coble: “Some symptoms are very vague. They may not cause alarm, and yet they may be related to a disease.”

Blumenthal counters that the FDA was right to restrict the definition of disease to obvious pathology.

“Some things are, in the opinion of many people, not disease. Many people think menopause is a natural condition of aging of the human body, for example.”

He wants the FDA to give manufacturers even wider latitude by allowing them to claim that their products can prevent or treat disease, when the evidence warrants. “With five clinical trials supporting it,” Blumenthal said, “it should be reasonable to say that cranberry juice helps prevent urinary tract infection. But [under the law] you can’t say ‘infection.’ ”

The FDA’s Dotzel acknowledged that there may be some disagreement about what is a condition as opposed to a disease. But, she said: “The rule doesn’t cover every possibility. To the extent that it can’t be 100% complete, you really have to look at these things on a case-by-case basis.”

Manufacturers still will be held accountable for their claims, which must be supported by scientific evidence. Dietary supplement products will be required to include a disclaimer on their labels saying that the products are not drugs and have not been approved by the FDA prior to going on the market.

No Promise That FDA Will Review Claims

Companies must notify the FDA of the claims they are making within 30 days of marketing a product, although Dotzel said the FDA may or may not review a claim. “I can’t say whether the center will look at each notification that comes in,” she said.

Blumenthal, of the herbal products group, predicts the biggest outcome of the new ruling may be that the FDA will start taking a closer look at health claims. Currently, in only about 10% of cases will the agency request evidence to support a health claim--or order a company to cease making a claim, he said.

But Silverglade, of the Center for Science in the Public Interest, disagrees that the FDA will now begin to pay closer attention to the health claims.

“I think the agency will be flooded with claims, and investigations will come after the fact. Consumers will be used as guinea pigs.”

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What They Can--and Can’t--Say

Under new federal rules, manufacturers of dietary supplements will be allowed to make more far-reaching health claims. All claims have to be supported by scientific evidence, but manufacturers don’t need to show that evidence to the FDA before marketing the product and need only produce it if asked.

Examples of claims that are currently permitted and will not change under the new rules:

“Promotes relaxation.”

“Supports the immune system.”

“Helps maintain a healthy prostate.”

Examples of new “stage of life” claims that will be permitted under the new rules:

“For mild memory loss associated with aging.”

“For hot flashes associated with menopause.”

“Can ease the symptoms of morning sickness.”

Examples of claims that still cannot be made without prior FDA approval:

“Prevents the spread of neoplastic cells.”

“Prevents seizures.”

“Prevents toxemia of pregnancy.”