Medical Foods is a unique regulatory category wedged between supplements and drugs, a category where nutrients can be marketed with a claim for the management of a disease. A claim that has led some to call this category “supplements on steroids”.
The opportunity to use a disease health claim is an attractive form of differentiation for most companies. It fulfills the dream of communicating efficacy in disease states— without walking down the drug development path.
Considering the price of medical foods are on-par with premium supplements, this product category is a sweet deal for many health product companies looking to stand out.
Regional Differences: The US vs the EU
In the US there is no formal approval process for a Medical Food, whilst the EU has a notification system for each member state, the burden of evidence is less than pharmaceuticals. Despite this apparent freedom, the development of clinical data and claims text is a narrow path if you want to remain compliant with regulations and prevent your product from tipping over to a drug or supplement.
Despite some variations, there are some important similarities in the core rules for Medical Foods in the US and the European equivalent Food for Special Medical Purposes (FSMP).
Regulatory Requirements
A Medical Food should provide nutritional support for the unique nutrient needs that result from the specific disease or condition.
Here lies one of the difficult areas of interpretation for you and your regulatory team. Smart companies should spend most of its waking hours discussing and re-visiting how to meet this demand.
In principle, the FDA is looking for products that meet the needs of in-born errors of metabolism:
- Inability to metabolize a nutrient
- Inability to absorb a nutrient
- Increased need of the nutrient due to the diseased state that diet alone cannot meet (for example, burn patients and amino acids)
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.
Many companies are overeager on this point and want to show that their nutrient has a significant impact on disease. Poor choice of words, poor clinical design, and over-enthusiastic marketing can result in responses from the FTC or FDA. The line between an effective nutrient in a disease context and a drug is fine. Therefore,the development plan and corresponding marketing claims need to resonate in one coherent and specific narrative that points to medical foods.
A Medical Food must be specially formulated.
This means you need to concentrate, synthesize, purify or formulate your nutrient. In other words, a banana cannot be a medical food.
A Medical Food must be intended to be given under medical supervision.
This can be interpreted as the use of a Medical Food requiring the recommendation or knowledge of your Doctor, a nutritionist, or maybe a nurse. The principle here is that a health care professional is required to co-ordinate and monitor the patient´s health and treatment options. Medical food is part of the holistic management of a patient and therefore should be under professional scrutiny.
Nutrient needs cannot be met by normal diet alone.
In other words, a deficiency should not result from a poor diet. A reasonable argument is required to demonstrate that a normal diet cannot meet the patient’s nutritional needs, even in the absence of good data for what a “normal diet” constitutes. Keeping in mind that a normal diet includes the use of supplements. If your product is a single nutrient then meeting this demand may hinge on dosage. Having a dose that’s higher than those normally supplied by supplements provides an argument for why supplements alone cannot meet nutrient needs. Higher dosage may require a specific GRAS procedure, but this is also a form of product differentiation and protection.
In Summary
Once the check list above is cleared, you are on your way to establishing your case for a medical food. Your next step is to convert this into a narrative with a style and language specific to the medical food category. There should be a flow and logical construction to your case. Begin with the deficiency in the disease population, the inability to meet that requirement through diet and supplementation, how your product specifically provides patients with that nutrient which helps restore the body's level of the nutrient and aids the body to re-establish a certain mechanism important in the body´s ability to normalize the disease.
The Medical Food category in the US and the FSMP category in the EU offer a unique opportunity to target nutrients for the management of diseases and conditions. While Canada lacks a category synonymous with Medical Foods, there are Foods for Special Dietary Use (FSDU) which may be an alternative in the Canadian market.
With the right clinical development plan, regulatory strategy and claims, this category offers a tantalizing opportunity to differentiate your product from the crowd and to provide real benefit to patients. The path is narrow but with the correct help that path can be straight.
Nutrasource staff have experience in the clinical development, regulatory positioning and marketing of medical foods in the US and EU. If you are thinking that medical foods/FSMP might be an option for you, don’t hesitate to contact us today.
Derek Tobin, P.hD.
Director of Business Development, Europe
