It is the end of summer in Washington, D.C., just prior to the fall presidential campaign. No serious work will be done in this town before the election in November. We can argue about whether this is a good or bad thing for the country, but it is definitely good news for this industry because certain senators who are not friends of the industry will not be able to push their anti-natural products agenda for the remainder of 2012.
From a regulatory perspective, the revised NDI draft guidance probably won’t see the light of day until next summer (at the earliest)—and what happens might largely depend on who is President by then (no predictions here). Yes, FDA and FTC will continue to look skeptically at our industry and the class action and Prop. 65 plaintiff attorneys will continue to bring lawsuits; some legitimate, some not. But overall, it will be a quiet fall.
With a new Congress and potentially a new administration coming in, maybe it is time to ask ourselves whether we need a new paradigm—one that does not destroy the Dietary Supplement Health and Education Act (DSHEA), but that builds on the hard-fought foundation it provides, i.e., to guarantee American consumers access to truthful and non-misleading information regarding the true benefits of dietary supplement products.
But what are the true benefits of taking dietary supplements? Surely, some of the true benefits revolve around supporting the basic structure and function of the body, i.e., “supports overall heart health” or “supports eye health.” However, consumers typically take dietary supplements for reasons beyond supporting or maintaining healthy structure and function of the body. In fact, they are usually trying to treat an ailment, such as high cholesterol.
For example, if a consumer has elevated cholesterol or blood pressure, does that mean he needs to take an FDA-approved drug to lower cholesterol or blood pressure? The answer is not necessarily. Taking a statin or an ACE inhibitor to address these two health concerns might not be necessary when simple modifications to the diet (i.e., adding a targeted dietary supplement) might very well bring one’s cholesterol and blood pressure back in the normal range. This makes significantly more sense than using a prescription drug.
Another example relates to people with blood sugar issues. Many could address this health problem by simply adding Gymnema sylvestre to their daily routines. For men whose prostate starts to grow because they are over 40, why shouldn’t they be provided with the opportunity to reduce nighttime trips to the bathroom through the use of beta-sitosterol and saw palmetto, rather than taking the prescription drug finasteride? If the supplements don’t work, then explore more powerful means. Until then, dietary supplements should be a legitimate first line of defense when health issues arise.
Of course, certain public health advocates and consumer groups would argue the reason why we do not allow dietary supplements to be promoted in this manner is to keep the consumer protected from snake oil salesman. Unfortunately, these individuals are misguided and misinformed. They ignore ancient uses of many herbal ingredients and the teachings of herbalists. They ignore the advances in science that have been able to identify the constituents that provide the potential benefits, enabling the development of standardized ingredients. More importantly, they ignore that as nutritional science has progressed over the years, we have learned that many chronic illnesses can be avoided by altering our diet.
In order to avoid the strictures, many companies have decided to market their products as medical foods or homeopathic medicines. The problem with the former is that many health issues we have today can be treated by adding a dietary supplement or a functional food to the diet. However, this is inconsistent with the medical food category because a medical food must offer benefits beyond simple modification to the diet.
The category of homeopathic drugs is an interesting one, but there are too many products being marketed as homeopathic that are not homeopathic. This is because the ingredients are not marketed in accordance with the dilution rates set forth in the Homeopathic Pharmacopoeia of the United States (HPUS) or the ingredients are simply not listed in the HPUS. So, where does this leave the industry? The answer is pretty simple: (1) Continue to market in accordance with DSHEA; or (2) Take a risk and develop a real regulatory framework that permits making meaningful claims to consumers.
Of course, making such a monumental change is not simple and requires legislation. The challenge to the industry is to come up with a viable legislative and regulatory framework. THE TIME IS NOW. Unfortunately DSHEA is restricting the growth of the industry and keeping it from making claims it should be able to make based on traditional use or scientific studies. Whether this is achieved through a monograph or application process, or combination thereof, it is time to move to the next level—without the fear of being called an unapproved drug.
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: firstname.lastname@example.org.