July 2013 US$39.00 SPECIAL REPORT Navigating the Regulatory Landscape of Marketing Omega-3 Supplements Given FDA’s reticence to establish an RDI for omega-3s, as well as its antiquated view of inflammation claims, companies are currently walking a nuanced tightrope to communicate the benefits of omega-3s to consumers while avoiding regulatory enforcement action for their product claims. by Todd Harrison and Erin Seder Navigating the Regulatory Landscape of Marketing Omega-3 Supplements by Todd Harrison and Erin Seder mega-3 fatty acid supplementation has a longstanding reputation of improving cardiovascular health, reducing overall inflammation, and O supporting cognitive health and eye function. According to a number of recent studies, it may also help reduce joint stiffness associated with rheumatoid arthritis, lower depression levels, support prenatal health, reduce the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children, and protect against Alzheimer’s disease, dementia and, potentially, cancer. And, according to a market report published by Transparency Market Research, the global omega-3 ingredients demand is expected to cross US$4 billion in 2018, which is an estimated growth of 15 percent from 2013. Considering the significant amount of money and research invested, one would think the dietary supplement industry would have little difficulty navigating the regulatory landscape of marketing omega-3 supplements. However, given FDA’s reticence to establish an RDI for omega-3s, as well as its antiquated view of inflammation claims, companies are currently walking a nuanced tightrope to communicate the benefits of omega-3s to consumers while avoiding regulatory enforcement action for their product claims. Omega-3 Supplements: A Dense Regulatory Landscape While there is technically no regulatory preapproval or screening process for dietary supplements before they hit the market, FDA has the primary responsibility of overseeing permissible product claims. Among the most commonly used claims are structure/function claims, nutrient content claims and health claims. FDA’s regulation of these claims has literally bound the hands of the omega-3 supplement industry so tightly that consumers are not being told the full gamut of substantial health benefits provided by omega-3 fatty acid supplementation. Omega-3 Insights • Marketing Omega-3 Supplements 2 omega3insights.com The Structure/Function Claim In general, structure/function claims describe the role of a dietary supplement in the structure and function of human bodies, but the claims may not explicitly or implicitly claim to prevent, treat, mitigate, cure or diagnose a disease. These claims can describe the role of a particular nutrient or dietary ingredient intended to affect normal structure or function in humans. For example, a supplement may claim, “Omega-3 fatty acids help maintain healthy eye, brain and nerve cells,” but it may not claim to “support eye health to treat macular degeneration.” Structure/function claims can also characterize the action by which a nutrient or dietary ingredient maintains such structure or function, or describe a benefit related to a nutrient deficiency Structure/function disease (e.g., vitamin C and scurvy), so long as the statement comments on how prevalent the disease is in the United States. claims describe the General well-being claims are also considered permissible structure/ role of a dietary function claims. Technically, a 30-day post-market notification must be submitted to FDA notifying the agency of a structure/function supplement in the claim’s wording. In practice, however, the industry as a whole does not comply with this requirement, and FDA has generally not raised structure and function this issue in warning letters to companies objecting to whether a of human bodies, but claim is a permissible structure/function claim or an impermissible disease claim. We would note some companies that have filed the claims may not structure/function claims will then tout that FDA approves the claim when it does not receive a letter of no objection. Please note FDA is explicitly or implicitly not reviewing whether a claim is substantiated; rather, it will only claim to prevent, treat, send a letter if it believes the form of the claim (i.e., is it a permissible structure/function claim) is an impermissible disease claim. FDA has mitigate, cure or generally let FTC deal with issues related to claims substantiation. Thus, those companies stating their claims are approved by FDA are diagnose a disease. making a false and misleading claim in and of itself. Nutrient Content Claims and Health Claims FDA’s notification process allows manufacturers and distributors to use health claims or nutrient content claims in dietary supplement labeling if the claims are based on current, published, authoritative statements from certain federal scientific bodies—and FDA does not object to the claims within 120 days of receipt of the notification. Claims authorized under the notification process may be used until FDA issues a regulation prohibiting or modifying the claim, FDA issues a regulation finding the statutory notification requirements have not been met, or a district court determines the statutory notification requirements have not been met. Omega-3 Insights • Marketing Omega-3 Supplements 3 omega3insights.com Nutrient content claims characterize the level of nutrients in a product (e.g., “low fat,” “low sodium,” “high protein,” etc.). Generally, nutrient content claims not explicitly authorized by FDA, either by regulation or petition, are prohibited. Because FDA has been remiss to assign an RDI for omega-3 fatty acids, dietary supplement companies have been limited—they may make nutrient content claims so long as the claim specifies only the amount of the omega-3s per serving and does not implicitly characterize the level of the nutrient in the product. For example, the claim “x grams of omega-3 fatty acids” is a permissible nutrient content claim, while “potent source of omega-3 fatty acids” is not. Further, when using the words “contains” or “provides” for nutrients without RDIs, such as omega-3 fatty acids, the specific amount of the nutrient must be stated. Consequently, the claim “contains x grams of omega-fatty acids per serving” or “provides x grams of omega-3s” is permitted. On the other hand, claims The claim “x grams of such as “contains omega-3 fatty acids” and “provides omega-3 fatty acids” are not. omega-3 fatty acids” Befuddling the industry’s understanding of permissible omega-3 is a permissible claims further was FDA’s 2007 issuance of a proposed rule prohibiting the use of most of the then-permissible nutrient content nutrient content claims for omega-3s alpha linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). At the time, omega-3 claim, while “potent nutrient content claims were lawfully on the market because FDA source of omega-3 had not objected to three notifications submitted between 2004 and 2006. The notifications proposed “high,” “good source” and fatty acids” is not. “more” claims for ALA, and “high” claims for DHA and EPA. In its 2007 proposed rule, FDA asserted that the nutrient content claims for DHA and EPA that had been submitted in notifications were not based on an authoritative statement that identified a nutrient level to which the claims referred. Therefore, such claims lacked an adequate scientific basis—and the claimed nutrient levels could result in consumer confusion. FDA did, however, leave some nutrient content claims for ALA alone, depending on the amount per product. Six years later, the proposed rule remains just that, proposed. Qualified Health Claims Health claims discuss the relationship between a nutrient and a disease or disease condition. The claim language, which is specifically approved by FDA and based on significant scientific agreement, is set in stone and may not be changed. Qualified health claims are based on less than scientific agreement, but the claim language discloses the limitations of evidence in support of the claimed relationship. Omega-3 Insights • Marketing Omega-3 Supplements 4 omega3insights.com In September 2004, FDA published a qualified health claim for reduced risk of coronary heart disease in conventional foods that contain EPA and DHA omega-3 fatty acids. Still in effect, the claim states: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]” To make the omega-3 qualified health claim, the product must meet the “low saturated fat” and “low cholesterol” criteria, and the food must contain at least 10 percent of the Daily Value of vitamin A, vitamin C, iron, calcium, protein or dietary fiber, prior to any nutrient addition. Specified levels of total fat, sodium, What qualifies as cholesterol or saturated fats can also disqualify foods. Moreover, “competent and reliable FDA requires dietary supplements not recommend or suggest in their labeling a daily intake exceeding 2 g of EPA and DHA. scientific evidence”? Claim Substantiation: Although FTC has What You Don’t Know Can Hurt You published a definition of All advertising claims must be truthful and not misleading, plus supported by competent and reliable scientific evidence. So, what the phrase, it remains qualifies as “competent and reliable scientific evidence”? Although FTC has published a definition of the phrase, it remains anything but clear. anything but clear. FTC defines competent and reliable scientific evidence as tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. As indicated in several recent consent decrees, the definition may include at least two adequate and well-controlled human clinical studies of the product or its substantial equivalent.