Medical Food vs Dietary Supplements: A Rebuttal to Clean Label Project

Kristine Burke, MD
April 6, 2018

There are a lot of differences between dietary supplements and medical foods that we should all consider. Dietary supplements have many forms. One form is protein powders sold on the internet or in locally advertised health food stores. Medical foods produced by medical supplement manufacturers are often confused with dietary supplements – perhaps because both may contain nutritional ingredients; however, the terms are not interchangeable and fall within discrete regulatory classifications.

Medical foods are intended to:
· Provide support for the nutritional management of a specific disease or condition that has distinct and established nutritional requirements.
· Be used under the supervision of a physician.
· Support those who have trouble digesting and absorbing food and certain nutrients and cannot nutritionally manage their condition through diet modification alone.

Dietary supplements and functional foods are intended to:
· Provide nutritional support for healthy people.
· Provide nutrients or dietary ingredients intended to affect normal structure of function in humans.

All medical food must be GMP-certified to be classified as a medical food. What is GMP-certified, you ask? Great question! GMP stands for Goods Manufacturing Practice and these regulations are implemented by the FDA. Good manufacturing practices (GMP) can be defined as the operational requirements necessary to enable a food business to produce food safely. These requirements help ensure that dietary supplement products are manufactured, prepared, and stored properly and meet certain quality standards. GMP-certified also means a respected entity monitors and certifies the facility where medical food is produced and raw material testing procedures performed on a constant basis. Metagenics, one of the reputable medical food companies our office uses, has third-parties test all their products. Only about 12% of all nutritional companies utilize these standards. This is required when you are a GMP-certified company, and not just GMP-compliant. Also, because Metagenics manufactures medical foods, they are open to increased scrutiny by the FDA, and welcome it to ensure their product quality is the very best.

A lot of you may have seen the recent articles, allegations, blogs and vlogs about the Clean Label Project’s recent “findings” of arsenic in commonly known protein powders. It is worth noting that the Clean Label Project has not published any research in support of these allegations and only provides a star rating, but no information to validate how these protein powders received this star rating. The Clean Label Project’s star rating includes a summary of metals and chemicals that only gives a generic description of those metals and how harmful amounts can affect the human body. In fact, their website even states in the “Arsenic/Mercury” tab, that not all arsenic is bad and that the “Clean Label Project tested for total arsenic and did not speciate into arsenic types.” We can see on the Clean Label Project’s website that the more popular plant-based protein powders (which will contain some arsenic, cadmium, etc. since it's naturally present in the earth), automatically get lower stars, but it would be more helpful if they shared the amounts of metals present that are at unsafe levels. We cannot avoid contact with these metals 100% because they’re naturally in our environment. This is even mentioned on the FDA website. So, what does this star rating even mean? It means nothing. There is no founding evidence of the kind of metals or chemicals Clean Label Project found, making their post irrelevant to the products they rated. Metagenics has been the victim of this misinformation, even though they undergo intensive scrutiny for approval of their products as medical foods and not merely dietary supplemental protein powders. And, as earlier stated, protein powders do not undergo as strict a certification process as medical foods. The Clean Label Project is also known to be an unreliable site that badmouths other brands to steer people to products where they make money. The Natural Products Association has a very strongly worded letter condemning their poor practices, junk "studies" (none of which are published for review). Because there is a lot of conflicting information on the internet, reputable physicians take considerable time and care selecting the best and safest medical foods, supplements, and other immune supporters for their patients so they do not fall prey to misleading, unfounded articles and studies to sway them towards their own products that could do more harm than good to the body.

Medical foods are designed to restore function during early phases of declining health by managing the nutritional deficiencies affected by a specific condition or disorder. While dietary supplements are great for maintaining healthy bodies, they do not restore. To ensure the best quality of products, talk to your physician. They have done all the research for you, and spoken with many manufacturing companies to find the best quality for their patients’ needs. Don’t fall victim to triggering posts. Absolutely do your research on the reliability and reputation of the company making these allegations, the products they’re discussing, and most importantly if there is profound research to back up the claims being made. If you have any concerns about products being prescribed by your physician, please be sure and ask them. There will always be layers of research to back up the products they recommend and why they chose that brand to help you reach your optimal health status.

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