Q: What are some of the legal issues for soy products?
A: There are several legal and regulatory issues pertinent to soyfoods and dietary supplements, including the National Organic Program, bioengineered foods and labeling, the U.S. Food and Drug Administration-authorized health claim linking soy consumption to reduced risk of heart disease, and structure/function claims linking soy to reduced menopausal symptoms.
Q: What is a health claim?
A: A health claim is a FDA-authorized statement about the relationship of a substance to a disease or health-related condition. A health claim may be authorized by FDA regulation or after significant scientific agreement is achieved. A company also may submit a petition to the FDA, including a statement from a government body such as the National Institutes of Health, about the substance's disease relationship at least 120 days pre-market. Examples of some FDA-approved health claims published as regulations are those linking calcium to reduced osteoporosis risk, oat bran to reduced heart disease risk, and fiber-rich fruits and vegetables to reduced cancer risk.
Q: How is a health claim different from a structure/function claim?
A: Structure/function claims for dietary supplements address health benefits whereas health claims link a substance to a particular disease or disease condition. Health claims are primarily intended for conventional foods. The FDA must approve health claims and they must be approved or authorized before being used in marketing.
Q: What is the soy protein health claim?
A: The exact wording of this claim is: Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides ___ grams of soy protein.
To qualify for this health claim, a food or supplement must contain at least 6.25 g of soy protein per serving, an amount one-quarter of the effective level. The FDA's reasoning is that soy protein can be added to a variety of foods, and thus it is possible for consumers to eat foods at all three meals and for snacks—or four times a day—and get a total of 25 g.
Both soyfoods and soy supplements, typically in the form of protein bars or protein shakes, are eligible to use the soy protein health claim.
Q: Besides the requirement that the food in question contain 6.25 g of soy protein per serving, are there other requirements?
A: To be eligible to use a health claim, conventional foods must contain at least 10 percent of the daily value for vitamins A and C, calcium, fiber, iron or protein per serving before any nutrients are added. Also, foods that contain a nutrient in any amount found by the FDA to increase the risk of a disease or health-related condition may not bear health claims unless the agency determines that the claims would assist consumers in maintaining healthy dietary practices.
Q: Can other health claims be made for soy? For example, there is evidence that soy may reduce the risk of breast cancer, prostate cancer, diabetes, arthritis, endometriosis and Alzheimer's disease.
A: No other soy-related health claims are approved. Before a product is marketed, the FDA must approve either a new regulation or a petition for a new health claim associating soy with a disease other than coronary heart disease to permit a claim. If companies make unapproved health claims, the FDA will take enforcement action. If an advertisement or promotion deceptively stated or implied an FDA-approved health claim, then the FTC also could take enforcement action.
Q: For soy supplements, what types of structure/function claims are permissible for women's products?
A: Dietary supplements containing soy, soy extract and tofu extract contain isoflavones and phytoestrogens, which may help reduce menopausal symptoms. If the manufacturer or marketer has adequate scientific substantiation, the following types of structure/function claims are permitted:
Helps relieve the common symptoms associated with menopause or PMS.
Helps alleviate mild mood swings associated with menopause or PMS.
Helps alleviate irritability associated with menopause or PMS.
Supports a normal, healthy attitude during menopause.
Helps alleviate hot flashes and minor sleep disturbances associated with menopause.
Helps normalize hormone production.
May help to normalize the ratio of progesterone to estrogen.
- Low estrogen may be responsible for some symptoms of menopause, and soy supplies plant estrogens.
However, a soy supplement claim, such as "a natural alternative to hormone replacement therapy," would likely be considered a drug claim, classifying the product as an unapproved new drug.
Q: Is a human clinical trial necessary before companies can use a menopause structure/function claim?
A: No, unless the claim states something like "studies prove that ours is the best hormone balancer." Although a large double-blind, placebo-controlled human clinical trial would provide the best evidence of efficacy for any supplement or ingredient, it is not necessary under the Dietary Supplements Health Education Act or Federal Trade Commission law. Depending on the exact wording of the claim, companies can use a synthesis of the scientific literature, including the history of traditional use (e.g., black cohosh as used by Native Americans), to provide sufficient substantiation.
Q: Are there other requirements for menopause structure/function claims on soy supplements?
A: Yes, companies must also:
Print the Disclaimer from Section 6 of DSHEA on the same label panel or page on which the claim appears, in bold.
- Submit a signed notification to the FDA, within 30 days post-market, stating that the claim is truthful, accurate and not misleading, and that the company in question has in its files adequate scientific substantiation for the claim.
Susan D. Brienza is an attorney who practices in the area of regulatory compliance in food and drug law at Patton Boggs LLP. Her e-mail address is [email protected]
Natural Foods Merchandiser volume XXIII/number 11/p. 15