The realm for cardiovascular health claims within the dietary supplement Industry is much narrower than it legally ought to be, and this is the real heart of the matter. Past experiences have contributed to an unfortunate restriction of potential claims.
Just because a statement is truthful does not mean it may be made in conjunction with the sale of a dietary supplement or food product. It is that simple. Ensuring any desired claim is going to be generally allowable by FDA is only the first determination to be made. In the area of claims concerning cardiovascular health, there is already a great bit of territory that is strictly off limits, regardless of the level of truthfulness. Moreover, this is an ever-narrowing field of claims, which is directly due to the “E” portion of DSHEA (Dietary Supplement Health and Education Act of 1994), which stands for education. The more educated consumers are, the less we, as an industry, are allowed to tell them. That may seem far-fetched, but the reality is exactly that; it has been the de facto approach since the initiation of the rulemaking process for what are known as structure/function claims.
During this process, FDA described what was called a “continuum” of knowledge and understanding held by the consumer. For example, claims regarding cholesterol are severely and directly limited since the consumer is sufficiently “educated” to automatically conflate the discussion of cholesterol levels with cardiovascular disease (CVD).
This is an excerpt from the article, “The Regulatory ‘Heart’ of the Matter.” To continue reading, download INSIDER’s Heart Health Digital Magazine.
As chief operating officer, Jim Lassiter oversees all consulting operations at Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.