In recent years, we have seen a proliferation of dietary supplement and functional food products being marketed as medical foods. Some of these products appear to have legitimate basis as they target populations with distinct nutritive needs. On the other hand, we have also seen significant growth in dietary supplement products masquerading as “medical foods,” consequently putting a vulnerable and unsuspecting public at risk. 

Many of these products are targeting vulnerable patient populations, in particular the elderly, with claims related to Alzheimer’s, osteoarthritis, rheumatoid arthritis, and stroke. These products do not appear on their face to relate to “the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” (21 U.S.C. § 360ee(b)(3).)

Rather, they appear positioned to justify the use of otherwise impermissible disease claims for dietary supplements. The FDA does not appear to believe there’s a need to address these products in a decisive manner. Rather, it continues to allow this pseudo-product category to grow, placing certain vulnerable patient populations at risk.

To be sure, there is a valid place for legitimate medical food products that are based on sound nutritional science and clinical research. Indeed, given the breadth of claims the FDA believes are impermissible disease claims, it makes sense to expand those products that are rightfully considered to be appropriate options for many diseases that have clear nutritional underpinnings. Moreover, FDA’s narrow definition of a medical food excludes products that would be particularly beneficial to certain patient populations, including those with type 2 diabetes, Irritable Bowel Syndrome (IBS), and male fertility issues related to oxidative stress.  

FDA’s overly restrictive view of what is considered a medical food is particularly troublesome. Without going into detail about FDA’s fatally restrictive position on medical foods, it is important to understand what the statutory framework for the Orphan Drug Act requires:

• The product must be used under the supervision of a physician.
• The substance must be recognized as a “food.” (Dietary supplements are foods under the Federal Food, Drug and Cosmetic Act.)
• The product must be a food that is specifically formulated to be consumed enterally (taken by mouth).
• The medical food must be for the “specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” 

Ready or Not? 
Over the years I have discussed how certain diseases or health-related conditions are ripe for medical foods, yet FDA does not believe this to be true. For instance, if there was ever a classic disease related to nutrition, it is type 2 diabetes or metabolic syndrome. (There is still some question whether FDA considers metabolic syndrome a disease or not.) The first intervention is not a prescription drug but lifestyle changes to maintain normal blood sugar levels. However, simply altering the diet is not necessarily an easy proposition, so it makes sense to permit targeted dietary ingredients in this definition.

But how does a particular dietary ingredient meet this need if it is not based on what we would normally consider a nutritive effect? This may be more easily accomplished for those with IBS than type 2 diabetes. The literature is replete with the benefits of probiotics for IBS patients and the benefits of probiotics should be considered nutritive not pharmacological.

Yet, FDA takes the position that probiotics are not appropriate medical foods for the dietary management of IBS. This position is likely related to the fact that individuals can do their own research and take a probiotic supplement, which is a simple modification to the diet. This interpretation strains credulity, as most IBS patients are not going to do the research or know the proper dosage to take to help manage their symptoms. Thus, by taking a blanket position that probitiocs are is not an appropriate medical food for IBS, the agency denies patients a dietary management tool that can have profound benefits.

Another area to consider is male reproductive health. There is mounting evidence that oxidative stress can impact the quality of male sperm. The agency takes the position this is an implied male infertility claim, which it is not, in my mind. However, if we accept the agency’s position for the purpose of this column only, why should we not be able to develop a medical food that is specifically designed to lower the impact of oxidative stress on male fertility through the use of targeted antioxidants?  

Access Restricted
The purpose of this column is to demonstrate that we have reached a point within the present regulatory paradigm where access to products that provide real solutions are not readily available to consumers. Moreover, the agency feels constrained to restrict medical foods and claims for dietary supplements. Yet, on the medical food front, FDA fails to go after the most egregious actors; and on the dietary supplement front, the agency wrongfully believes that oxidative stress and male fertility, for example, is an implied disease claim.

This confluent set of events causes more companies to either strain the definition of medical foods to include osteoarthritis, or develop claims (e.g., “supports blood sugar levels already in the normal range” or “supports joint comfort”) that have little value to consumers and patients. 

Changing the Regulatory Paradigm
To regular readers of this column, it is known that I have been a longtime advocate (to the dismay of some) that our regulatory paradigm must evolve to be consistent with reality and common sense. Rather than viewing health as a binary proposition between disease and health, we need to understand that many things FDA considers to be a disease are actually part of the normal aging process. For instance, I recently had an MRI that disclosed a partial tear in my rotator cuff, however, it also disclosed that I have the start of osteoarthritis in my elbow and shoulder, coupled with inflammation. As my doctor made clear, “you are 55 years old and this is a common part of aging even though it has a disease moniker attached to it.”

My rotator cuff may need to be repaired if physical therapy does not work, but the osteoarthritis will remain. Under the present paradigm, I have one of two choices for pain relief: prescription drugs or OTC drugs, all of which have serious side effects related to long-term use. However, I also admit that I do not have a distinct nutritional need for curcumin or glucosamine. So where does this leave me? Fortunately, I know what works and what does not. But the typical consumer will need to decipher code words on a dietary supplement bottle or purchase a medical food that really isn’t a medical food. This situation does not make sense.

Here’s a simple solution. Because the industry as a whole is afraid to reopen the Dietary Supplement Health and Education Act, I have a new proposal:

• Reopen the definition of a medical food under the Orphan Drug Act to include dietary ingredients that have nutritive value or therapeutic value;
• Permit dietary management claims for diseases that have a significant nutritional component (e.g., type 2 diabetes, stage 1 high blood pressure, IBS);
• Permit therapeutic claims for all other conditions that are already permitted for OTC drugs (e.g., osteoarthritis, GERD, cough/cold);
• Restrict those products intended to provide dietary management for more serious conditions, but still manageable through dietary intervention (e.g., type 2 diabetes, IBS) to be sold behind the counter without a prescription or through physician offices;
• Require companies to list and register with FDA;
• Require the submission of a dossier to FDA in support of the medical food’s safety and efficacy for the intended patient population;

           - Limit FDA’s review of the dossier;
           - FDA may only object if it is clear there is no basis for the product to be marketed as a dietary supplement;
           - Setup an independent third-party review process when FDA objects. 

It’s clear the present regulatory scheme is out of date and requires significant revisions to reflect modern realities. More and more companies are entering the medical food arena because they view it as a large loophole to disease claims. Some of these medical foods are legitimate while some are not, but regardless, FDA seems unwilling to act decisively with those that are clearly not. On the other hand, we do not want to sweep away products that are legitmate and will help a significant number of individuals improve their health. The disease/health paradigm we have created is broken and cannot address the changes in society, flow of information, and the ability of rogue companies to market any product they choose.

Bold action is required. We are not growing healthier in this country. People are sicker because we fail to understand that not everything is a disease that requires strong pharmaceutical intervention. The latter is certainly necessary, but think of the good we could create if we gave the supplement and pharmaceutical industries a path to development of nutritive products that are lawfully sold without fear of FDA or plaintiff class action lawyers who sue companies under state law because of disease claims.

It is time for a change. Are we as an industry willing to lead that change, or will we continue to ignore problems that the primary statutory and regulatory framework has created? My hope is the former.

---

Todd Harrison
Venable

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: taharrison@venable.com.