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As Medical Food Industry Grows, So May FDA Scrutiny

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On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The Warning Letter represents the FDA's first significant action specific to the unique regulatory category of medical foods in over a year, and one of only a few Warning Letters issued by the agency since it published an updated medical foods guidance in May of 2016.

As the surging medical foods market is projected to more than double in the next decade, it is equally poised to attract increased regulatory scrutiny from the FDA. Here is what we know about the agency's positions, and what we may expect as the market continues to expand.

Medical foods were defined by Congress in 1988 as "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended 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." In 1993, the FDA announced a product meets the statutory definition of "medical food" if it satisfies the following criteria:

  1. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;
  2. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
  3. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
  4. It is intended to be used under medical supervision; and
  5. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Since the 1990s, the industry has struggled to understand the FDA's ambivalent position toward medical food regulation as the FDA itself has largely failed to specify categories of diseases or conditions it views as appropriate for treatment by medical foods. A sampling of FDA Warning Letters from 2012 – 2017, including the recent Warning Letter issued to ND Labs, illustrates the FDA's intent to narrowly construe the statutory definition of "medical food" in order to constrain the types of products that fit within the specialty category. Although the FDA's apparent constraints on medical foods seem very narrow, it is important to note that many of the diseases and conditions highlighted in agency Warning Letters as inappropriate for treatment by medical foods are more likely the result of inapposite regulatory positioning and not reflective of an outright prohibition on future use or treatment for the specific diseases or conditions referenced. For example, IBgard®, a medical food for the management of Irritable Bowel Syndrome, has achieved commercial success presumably due in part to apparent, strong clinical data and professional support – despite prior agency pronouncements in multiple Warning Letters that medical foods were inappropriate for treatment of inflammatory bowel conditions.

While the FDA's current position on medical food regulation is somewhat difficult to discern and still evolving, certain aspects of medical food regulation are clear and offer significant commercial opportunity in the right circumstance. For example, medical foods are legally neither drugs nor dietary supplements, do not require a prescription, do not require premarket review or approval by FDA and, importantly, are exempt from the 1990 Nutrition Labeling and Education Act health claim and nutrient content claim requirements applicable to most other foods, including dietary supplements. Accordingly, an important and distinct advantage for medical food status is the ability to affirmatively claim, in both labeling and advertising, that a particular medical food may assist in the treatment or management of a specifically identified disease condition. Such positioning is in sharp contrast with the disclaimer required by The Dietary Supplement Health and Education Act of 1994 governing labeling of dietary supplements. Medical foods must still, however, comply with all other applicable food labeling requirements.

While medical foods have existed for nearly 30 years as an emerging regulatory category, the industry has only recently experienced significant growth. Increasingly, more sophisticated health care companies and innovators are seeking to capitalize on the marketing benefits available to medical foods in the form of permitted disease claims and exemption from labeling requirements. The economic efficiency of disease management utilizing unique product formulations is also attractive in today's political environment.

Recent industry growth has been realized by start-ups entering the category and established companies seeking to implement dietary supplement-to-medical food "switches" which have, at least so far, enjoyed commercial success, apparently without FDA objection. Medical foods are also often being labeled and advertised in packaging similar to dietary supplements, but with the addition of specific disease management claims that would be prohibited by traditional dietary supplement regulation, further spurring an increase in overall industry growth. The consumer health care industry, too, is taking recognition of the potential behind the growth of medical foods. Just recently, in July of 2017, the Council for Responsible Nutrition – the leading trade association for the dietary supplement and functional food industry – announced it was exploring representation for companies in the medical food industry to its mission, providing the industry with a potential powerful ally in Washington, D.C.

The overall outlook for the medical food industry appears bright, but also unsettled. As of 2015, the global medical foods market was valued at $12 billion USD and is expected to more than double by the year 2025 as companies continue to invest resources in medical food research and development, and as consumers continue to be drawn in by specific disease management marketing and labeling claims that other categories of FDA-regulated products are prohibited from making. FDA scrutiny, however, is also certain to increase as medical food sales continue to surge and new products enter the market. Given the FDA's history of containing and limiting the types of products that fit within the medical foods category, companies seeking to enter the medical food market – or considering whether a dietary supplement-to-medical foods 'switch' is appropriate – would be well-advised to seek knowledgeable counsel to assist in all aspects of the product development strategy and implementation.

For more information about medical foods or how these issues may affect your business, please contact Kyle Diamantas or any member of Baker Donelson's FDA Group.

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