If you have been in the Natural Wellness space for any amount of time, you have heard someone say "dietary supplements are not regulated." It is not hard to find evidence of that. A Google News search results in 146 recent articles where that phrase appears and 9,400 web hits. Even reputable organizations are getting it wrong. For example, the American Cancer Society website cancer.org states:
"All prescription and non-prescription drugs are regulated in the United States by the Food and Drug Administration (FDA). But dietary supplements are treated more like special foods."The implication is the FDA does not regulate dietary supplements.
The reality is the FDA as well as other agencies do regulate dietary supplements.
The FDA views drugs and dietary supplements differently because they have two different purposes and primarily come from different production paths. Drugs are synthetic chemicals foreign to the human body and are marketed specifically to diagnose, treat, cure and mitigate disease. Dietary supplements, very specifically, are not. Dietary supplements in fact, are categorized as food because they have a long history in the human diet and are made with natural or bio-identical ingredients. Drugs must go through clinical trials to prove they are safe and effective and treat or cure disease.
The FDA defines supplements as intended for nutritional purposes only. For example, if you fail to ingest foods containing vitamin C for three months, there is a risk of contracting scurvy. If you happen to contract scurvy, you can take an FDA-approved drug called Ascor L500, manufactured by McGuff Pharmaceuticals in Santa Ana, CA. This treatment will cure scurvy in about a week.
The alternative is to consume food or supplements containing vitamin C over a one- to three-month period to treat scurvy. A proactive approach to preventing scurvy is consistently healthy attention to vitamin C intake. Consuming vitamin C in any form, an orange or a capsule, tablet, liquid, etc., will prevent scurvy from occurring. However, McGuff Pharmaceuticals can tell you their Ascorbic Acid can treat or cure scurvy disease. The oranges and vitamin C capsules providers cannot say they can treat, cure or mitigate scurvy. The FDA approves Ascor L500 for the treatment of scurvy but not oranges or vitamin C capsules.
The scurvy example is easily recognized and illustrates why the FDA decided to treat dietary supplements more like food than drugs. We’ve learned the nutritional importance of vitamin C over the past 300 years. We learned the importance of good nutrition far before that.
The recent Op-Ed by Sarah Green Carmichael appeared in Bloomberg Opinion titled "FDA's Abundance of Caution Should Extend to Supplements." The article's basic premise is that the FDA should apply the same "abundance of caution" to supplements as they did the Johnson & Johnson COVID-19 vaccine. I want to agree with Ms. Carmichael, but I can't, and here is why:
Carmichael defines supplements as vitamins, hormones, herbs, enzymes, and probiotics and states that they are all lightly regulated, and that the existing rules are poorly enforced. First, hormones are largely FDA-Approved andconsidered as drugs by the organization. One exception to this definition of a hormone is vitamin D.
Next, the term "lightly regulated" does not apply. The reality is that dietary supplements aredifferentlyregulated, and there is ample reason for this. Dietary supplements, the products themselves, are not FDA-Approved but there are rules, regulations, procedures, and processes that are required for ingredients, finished products and all facilities involved. The Food and Drug Administration states on its website:
FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):
- Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
- FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
When it comes to product safety benchmarked as the number of product recalls, drugwatch.com states over 4,000 FDA-approved drugs and devices are recalled annually. The FDA cannot recall a product nor force a company to do so. The FDA can recommend a recall, and the manufacturer usually complies, but the manufacturer is not required to recall even if the FDA determines it should. Bottom line, an FDA approval and FDA oversight does not guarantee safety. In 2019, the FDA reported only 14 recalls of dietary supplements.
Now let’s talk efficacy.
Dietary supplements are often criticized for not providing the same evidence of efficacy as drugs are expected to provide. The FDA requires determination of efficacy through testing of individuals who are already sick. Healthy nutrition from food or supplements is designed to reduce the likelihood of contracting the disease, and it is a complicated (if not impossible)—process to meet the same standard of efficacy as for drugs, which is why the entire structure function claim environment has been established for supplements—looking at physiological or health outcomes based on structure, markers, etc.
Now that we have determined the difference between FDA-approved drugs and devices and FDA-regulated food and dietary supplements, let's look at the FDA regulation of dietary supplements:
- The FDA and the FTC regularly review marketing materials from labels to websites to ensure dietary supplement companies do not make claims that their products prevent, treat, cure, or mitigate diseases.
- The FDA regularly inspects dietary supplement manufacturing facilities to ensure proper manufacturing practices. In 2007, the FDA codified Good Manufacturing Practices for manufacturers. This action allowed manufacturers to be put on notice that an FDA standard of manufacturing process and practice is in place. The FDA requires that dietary supplements will be expected to be manufactured to specific standards. The FDA required all manufacturers to be registered and established a website for the public to monitor these inspections.
- The FDA reviews and approves the introduction of new ingredients to the market through a process of affirmation of safety (generally recognized as safe) or as a new dietary ingredient (NDI).
- The FDA has the authority to mandate marketplace removal of an ingredient deemed harmful.
- The FDA requires companies to provide notification of claims it intends to make within 30 days of that product entering the market. If a company makes unsubstantiated claims, the FDA and the FTC can intervene and take action against the offenders.
- The FDA has the authority to inspect all aspects of the brand's manufacturing, labeling, ingredients, storage, and testing.
- The FDA mandates a brand must consider manufacturing a product its responsibility even if a third party does the manufacturing.
- The FDA mandates that if a product is manufactured outside of the United States, the labeling must provide that information.
- The FDA is provided guidance and authority through several laws dating back to 1938 with the Federal Food, Drug and Cosmetic Act. Other legislation impacting the regulation of dietary supplements include:
- Fair Packaging and Labeling Act of 1967
- Nutrition Labeling and Education Act of 1990
- Dietary Supplement Health and Education Act of 1994
- Bioterrorism and Preparedness Act of 2002
- Food and Drug Administration Food Safety and Modernization Act of 2010
The argument expressed and implied in the Op-Ed that FDA’s caution should extend to supplements and that the FDA is the answer to responsible manufacturing of any product, drug, device or food, is obviously flawed. In today's world of facts and education, the best resource a consumer can trust is the informed retailer that completes due diligence on the products they carry in their stores. It is on us as dietary supplement flagbearers to understand and communicate the true regulatory and safety environment for responsibly manufactured dietary supplements.