Institute for Food Laws and Regulations

Neal Fortin, Director of MSU’s Institute for Food Laws and Regulations, sat down with Rachel Morris, Ph.D. MLT(ASCP) and Alyssa Preiser, Ph.D. to discuss nutritional supplements on their “Speaking Science” podcast.

You can listen to the 20-minute podcast here: https://speakingsciencepodcast.com/2020/07/02/food-and-nutrition-supplements/

Here are the key takeaway quotations from Prof. Fortin related to the regulation of food fortification and dietary supplements:

• Definition: a dietary supplement is something that supplements the diet, which is a great circular definition, and really doesn't tell you anything at all. But we have three exclusions. What a dietary supplement is not, is actually more defined in the law than what it is. It cannot be a traditional food, it cannot be a complete meal, and it cannot be a tobacco product. Other than that, it can be pretty much anything, as long as it supplements the diet.

• There is a difference between fortification, and dietary supplements. When something is put in a food, such as Vitamin D in milk, it is regulated differently as an ingredient than when it is in a pill form as a dietary supplement.

• Just because a supplement is regulated by FDA doesn't mean it's regulated the same as a food ingredient or a drug. There is no requirement that dietary supplements are to be proven safe before being put on the market. That's not true with food ingredients or drugs, there's no requirement that the claims for benefits have to be proven. That's not true with drugs.

• It was a Congressional decision to make the dietary supplement market a more open market, which, depending on what your philosophy is, is good or bad. If you believe in allowing consumer freedom of choice, “buyer beware but let us have the choice,” then you will like this scheme of regulation under dietary supplements. But you have to remember that it is “buyer beware,” it's not the same as a food ingredient, it's not the same as a drug, it hasn't been proven to be safe, it hasn't been proven to be effective, and you have to do your own research.

• Who has the burden of proof of safety or risk makes a tremendous difference in the marketplace. For example, it's the difference of 200 people dying from Ephedra (marketed as a weight loss aid) before FDA can get it off the market, versus having to prove it is safe first, and then you don't have the deaths.

• There are there are limits on the labeling and on the marketing of supplements. The Federal Trade Commission regulates advertising, but again, the burden of proof is on the FTC or the FDA to prove that a claim is false. This it creates a problem - it will allow a lot of shady stuff to go on before they can take action - it has to get to be pretty egregious before the agencies can step in with enough evidence to stop something.

• Sometimes people get confused because it is against the law for a supplement manufacturer to make a false claim, but it is on the FDA and FTC to prove that it is false.

• Regarding regulation of the market for dietary supplements: it is either a success story or a disaster depending on your philosophy. If you believe in consumer freedom and “buyer beware/take your chances,” then it is a success story. Congress wanted to foster and encourage this market, and that is fine for cherry juice concentrate and garlic extract and things like that, but the category is so broad. But again, it is a belief-based value system of “let consumers choose” vs. government regulating it for safety. I also think of it as a value of belief vs. science, because frankly it is expensive to prove that these things are safe, it is expensive to prove that a novel substance is effective, and it would shrink the market if companies had to incur these expenses. So, it’s a value judgement, do I want science, or do I want consumer freedom with “buyer beware?” I try to be neutral on it but the thing that bothers me is when people don’t realize it’s “buyer beware.” That was a choice made by Congress, and you have to look at it as “buyer beware.”

• The NIH Office of Dietary Supplements has a great database of all the scientific research in English on the research on dietary supplements.

• Just because something is natural doesn't mean that it's safer. Remember, a supplement could be anything, anything to supplement the diet. It isn't just the natural herbs and other botanicals, it's anything.

• There is no such thing as a “completely safe” dietary supplement. Some are incredibly low risk, but others are riskier, and the varied diet is still the most important source of your nutrition. Your mother was right, eat your vegetables.

Disclaimer.

You can read the full transcript here: https://www.canr.msu.edu/resources/fortin-speaking-science-transcript

Learn more with an online graduate course in United States Food Laws and Regulations: https://www.canr.msu.edu/courses/food-laws-and-regulations-in-the-united-states