Bloomberg Op-Ed on Supplement Risk Conveniently Ignores Reality

A recent editorial published in Bloomberg Opinion suggested that current FDA caution and risk aversion related to COVID-19 should immediately extend to dietary supplements. Not only is this piece wrong, it spreads a lot of lies that we as the supplement industry have been trying to debunk for decades.

If you’ve been in the Natural Wellness area for any length of time, you’ve heard someone say that “food supplements are not regulated”. It is not difficult to find proof of this. A Google News search returned 146 recent articles in which this phrase appeared and 9,400 web visits. Even reputable organizations are wrong. For example, the American Cancer Society’s website states:

“All prescription and over-the-counter drugs are regulated in the United States by the Food and Drug Administration (FDA). But food supplements are treated more like special foods. “

The implication is that the FDA does not regulate dietary supplements.

The reality is that the FDA and other agencies regulate dietary supplements.

The FDA views drugs and dietary supplements differently because they serve two different purposes and mainly come from different production routes. Drugs are synthetic chemicals that are foreign to the human body and are marketed specifically to diagnose, treat, cure, and alleviate disease. Food supplements, to be precise, are not. In fact, dietary supplements are categorized as food because they have a long history in the human diet and are made with natural or bioidentical ingredients. Medicines must go through clinical trials to prove that they are safe and effective and to treat or cure the disease.

The FDA defines supplements as being for nutritional purposes only. For example, if you do not eat foods containing vitamin C for three months, there is a risk of getting scurvy. If you get scurvy, you can take an FDA-approved drug called Ascor L500, made by McGuff Pharmaceuticals in Santa Ana, California. This treatment will cure scurvy in about a week.

The alternative is to consume foods or supplements containing vitamin C over a period of one to three months to treat scurvy. A proactive approach to preventing scurvy is always to pay healthy attention to vitamin C intake. Consuming vitamin C in any form, orange or capsule, tablet, liquid, etc., will prevent scurvy to occur. However, McGuff Pharmaceuticals can tell you that its ascorbic acid can treat or cure scurvy. Suppliers of oranges and vitamin C capsules cannot say they can treat, cure, or alleviate scurvy. The FDA approves Ascor L500 for the treatment of scurvy but not oranges or vitamin C capsules.

The example of scurvy is easily recognized and illustrates why the FDA has decided to treat dietary supplements more like food than medicine. We have learned about the nutritional importance of vitamin C over the past 300 years. We learned about the importance of good nutrition long before that.

Sarah Green Carmichael’s recent editorial appeared in Bloomberg’s advisory titled “FDA’s Abundance of Caution Should Extend to Supplements.” The basic premise of the article is that the FDA should apply the same “caution” to supplements as the Johnson & Johnson COVID-19 vaccine. I agree with Ms. Carmichael, but I can’t, and here’s why:

Carmichael defines supplements as vitamins, hormones, herbs, enzymes, and probiotics and states that they are all lightly regulated and that existing rules are poorly enforced. First, hormones are largely approved by the FDA and considered drugs by the organization. An exception to this hormone definition is vitamin D.

Then the term “lightly regulated” does not apply. The reality is that food supplements are differently regulated, and there are many reasons for this. Dietary supplements, the products themselves, are not approved by the FDA, but there are rules, regulations, procedures, and processes that are necessary for the ingredients, the finished products, and all of the facilities involved. The Food and Drug Administration states on its website:

The FDA regulates both finished dietary supplements and dietary ingredients. The FDA regulates dietary supplements under a different set of regulations than those that cover “conventional” foods and pharmaceuticals. Under the Food Supplement Health and Education Act 1994 (DSHEA):

      • Manufacturers and distributors of food supplements and dietetic ingredients are prohibited from marketing adulterated or mislabelled products. This means that these companies are responsible for the safety assessment and labeling of their products before they are released to ensure that they meet all the requirements of the DSHEA and FDA regulations.
      • The FDA is responsible for taking action against any adulterated or mislabelled dietary supplement after it hits the market.

So even the FDA says it regulates both finished dietary supplements and dietary ingredients.

When it comes to product safety compared to the number of product recalls, reports that more than 4,000 FDA-approved drugs and devices are recalled each year. The FDA cannot recall a product or force a company to do so. The FDA can recommend a recall, and the manufacturer generally complies, but the manufacturer is under no obligation to recall even if the FDA deems it necessary. Bottom line, FDA approval and FDA oversight does not guarantee safety. In 2019, the FDA reported only 14 dietary supplement recalls.

Now let’s talk about efficiency.

Dietary supplements are often criticized for not providing the same evidence of effectiveness that drugs are supposed to provide. The FDA requires that efficacy be determined by testing people who are already sick. Eating a healthy diet from foods 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 level of effectiveness as for drugs, i.e. This is why the entire environment for claiming structure function has been established for supplements – looking at physiological or health outcomes based on structure, markers, etc.

Now that we’ve determined the difference between FDA-approved drugs and devices and FDA-regulated foods and supplements, let’s take a look at the FDA’s regulations for dietary supplements:

  1. The FDA and FTC routinely review marketing materials from labels to websites to ensure that dietary supplement companies are not claiming that their products prevent, treat, cure, or alleviate disease.
  2. The FDA regularly inspects dietary supplement manufacturing facilities to ensure good manufacturing practices. In 2007, the FDA codified good manufacturing practices for manufacturers. This action has enabled manufacturers to be made aware that an FDA standard for manufacturing processes and practices is in place. The FDA requires that dietary supplements be manufactured to specific standards. The FDA has required all manufacturers to be registered and has created a website for the public to monitor these inspections.
  3. The FDA reviews and approves the introduction of new ingredients to the market through a Safety Affirmation Process (Generally Recognized as Safe) or as a New Dietary Ingredient (NDI).
  4. The FDA has the power to require the removal from the marketplace of an ingredient deemed to be harmful.
  5. The FDA requires companies to notify claims they intend to make within 30 days of this product entering the market. If a company makes unsubstantiated claims, the FDA and FTC can step in and take action against the violators.
  6. The FDA has the authority to inspect all aspects of the brand’s manufacturing, labeling, ingredients, storage and testing.
  7. The FDA orders a brand to consider the manufacture of a product under its responsibility even if a third party does the manufacture.
  8. The FDA requires that if a product is manufactured outside of the United States, the labeling must provide this information.
  9. The FDA receives guidance and authority through several statutes dating from 1938 along with the Federal Food, Drug and Cosmetic Act. Other laws impacting the regulation of dietary supplements include:
      • Fair Packaging and Labeling Act 1967
      • Nutrition Labeling and Education Act, 1990
      • Food Supplement Health and Education Act 1994
      • Bioterrorism and Preparedness Act 2002
      • Food Safety and Food and Drug Administration Modernization Act, 2010

In addition to FDA oversight and regulation, other agencies, departments, and organizations such as the FTC, the US Department of Justice, attorneys general, class action attorneys, and advocacy groups industry such as Trust Transparency Center bring education and transparency to fundamental security and legitimacy. of the dietary supplement industry.

The argument expressed and implied in the Op-Ed that the FDA warning should extend to supplements and that the FDA is the response to the 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 who does due diligence on the products they sell in their stores. It is up to us, as the standard bearer of dietary supplements, to understand and communicate the true regulatory and safety environment for responsibly manufactured dietary supplements.

About Margie Peters

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