Last week, FDA issued a proposed rule to revoke a health claim for soy protein and coronary heart disease. According to a statement from FDA/CFSAN Director Susan Mayne, the revocation is being sought “because numerous studies published since the claim was authorized in 1999 have presented inconsistent findings on the relationship between soy protein and heart disease.” The only authorized health claim at issue is that of soy protein and reduced risk of coronary heart disease. It is the first time that the agency has proposed a rule to revoke a health claim – is it signaling a new focus for FDA? I, personally, don’t yet have a read on that, but what I can say is that industry needs to be aware that health claims are being looked at, so you need to know what is in and what is out. Further, industry needs to be careful about what they say about a product relating to a health claim. But keep in mind that FDA has various types of health claims. The most robust, which is what the soy protein claim was, is called an FDA authorized health claim. This level of claim must reflect well-established relationships based on the most robust level of scientific evidence. The other type of claim is a qualified health claim in which the evidence is less strong. For example, in the soy protein situation, FDA intends to move it to a qualified health claim in which there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. These definitions are further expanded below. What is in? Currently FDA has authorized 12 health claims, including: Calcium, Vitamin D, and Osteoporosis (21 CFR 101.72) Dietary Lipids (Fat) and Cancer (21 CFR 101.73) Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (21 CFR 101.75) Dietary Non-cariogenic Carbohydrate Sweeteners and Dental Caries (21 CFR 101.80) Fiber-containing Grain Products, Fruits and Vegetables and Cancer (21 CFR 101.76) Folic Acid and Neural Tube Defects (21 CFR 101.79) Fruits and Vegetables and Cancer (21 CFR 101.78) Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble fiber, and Risk of Coronary Heart Disease (21 CFR 101.77) Sodium and Hypertension (21 CFR 101.74) Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (21 CFR 101.81) Soy Protein and Risk of Coronary Heart Disease (21 CFR 101.82) Stanols/Sterols and Risk of Coronary Heart Disease (21 CFR 101.83) (For the related rules on each, see Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard) What is out? The only health claim that FDA lists as denied is the 2007 submission that Alkaline and Earth Alkaline Citrates minimize the risk of osteoporosis. The agency concluded that the proposed health claims for use in the labeling of dietary supplements did not meet the SSA standard in 21 CFR 101.14(c). How does FDA make the determination? While FDA recognizes that some foods and nutrients can help reduce the risk of certain diseases or conditions, it is responsible for evaluating health claims on packaged foods to ensure they are rooted in strong science. As indicated by this initial claim revocation, FDA continues to evaluate new science for existing claims. In proposing to revoke the soy claim, for example, Mayne states, “While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – the totality of currently available scientific evidence calls into question the certainty of this relationship.” What happens if the claim is revoked? If the rule is finalized, FDA will allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. What is a “qualified” claim? There are three categories of claims that can be used on food and dietary supplement labels: health claims (including qualified claims), nutrient content claims, and structure/function claims. Health Claims describe a relationship between a food substance (whether a food, food component, or dietary ingredient) and reduced risk of a disease or health-related condition for use in food labeling (e.g., adequate calcium throughout life may reduce the risk of osteoporosis). The claim must meet certain criteria and be authorized by an FDA regulation. A new food health claim can be authorized by submitting a notification to FDA of a claim based on an “authoritative statement” from certain scientific bodies. The method cannot be used for dietary supplements at this time. Qualified Health Claims are similar, but require a lower scientific standard of evidence than an authorized health claim. FDA will consider petitions for the use of a qualified health claim when there is emerging evidence of a food substance/health relationship that is not well enough established to meet the health claim standard. In such cases, FDA issues a letter outlining the circumstances and qualifying language under which it can be used on any food or dietary supplement product meeting the conditions. Nutrient Content Claims describe the level of a nutrient in the product (e.g., free, high, low) or compare the level in one food to that of another (e.g., more, reduced, lite). To be used, the food must meet the nutritional criteria for the nutrient content claim. So a food label can include quantitative statement (e.g., 200 mg of sodium) but not “only 200 mg of sodium” implying that it is low, unless it meets the criteria for the claim or carries a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Certain Dietary Supplement Claims are not pre-approved by FDA and include a “disclaimer” that FDA has not evaluated the claim and that the product is not intended to “diagnose, treat, cure or prevent any disease.” Additionally, the manufacturer must have substantiation that the claim is truthful and not misleading and submit a claim notification to FDA within 30 days of its marketing. Included are: structure/function claims that describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body (e.g., calcium builds strong bones) or the means by which it acts to maintain the structure or function (e.g., fiber maintains bowel regularity); general well-being claims, describing general well-being from consumption of a nutrient or dietary ingredient; and nutrient deficiency disease claims of a related benefit (e.g., vitamin C and scurvy), but a statement on the extent of the disease’s spread in the U.S. must be included. Neither FDA notification nor disclaimers are required for structure/function claims on conventional foods. (For more information on these, see FDA’s Label Claims for Conventional Foods and Dietary Supplements.) What happens next? Until FDA makes its final decision, manufacturers can keep the current authorized claim on their products. Meanwhile, if you’d like to have your say on the matter, you can submit comments on the proposed rule for 75 days. We wanted to bring health claims into focus for our readers. Many food companies like to make health claims because it can help sell a product. But, the message here is that FDA is continuing to watch this space. So, if you are making claims check the regulations to make sure you are in compliance. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
