Note: This article has been updated to include additional links and references.
Dietary supplements are under attack again, and this time from an unanticipated source: a Harvard-based organization, STRIPED (Strategic Training Initiative for the Prevention of Eating Disorders). This group claims that dietary supplements, especially those that they refer to as diet pills, cause eating disorders. Part of their efforts have been to propose age restricted legislation in various states, including New Jersey, Rhode Island, New York, California, Colorado, Missouri, Maryland, and Massachusetts, some of which have come close to passing. While the details of the proposed legislation vary from state to state, the main objective of all of them is to limit access of teens to specific dietary supplements that they refer to as “weight loss” or “diet” supplements. These include protein, creatine, branched chain amino acids, and diet pills, which are not clearly defined. The research they reference to support their platform is full of scientific holes, which are discussed in a recent review published in Nutrients.
In addition to the scientific holes in their position, there is a lack of evidence to support any adverse event associated with dietary supplements and eating disorders. This information is easily accessible to the public. For example, the CFSAN Adverse Event Reporting System (CAERS) is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN's safety surveillance program. Adverse events (AEs) are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The MedDRA terminology is used to assess AEs and to group them as part of the data package. Greatly assists in AE identification.
Downloadable - Searchable FDA CAERS (adverse events) database:
- https://open.fda.gov/data/caers/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6568094/
- https://www.burgsimpson.com/ohio-blog/fda-adverse-event-databases/#:~:text=Cosmetics%2C%20Dietary%20Supplements,not%20currently%20available
Any citizen can submit a FOIA request related to dietary supplements. More specifically, one could request all information that the FDA has regarding reported AEs from dietary supplements. As part of a query, one could ask for any reported AE of eating disorders related to any dietary supplement.
With a basic understanding of FOIA requests, we can share that there have been numerous confirmations made that there are no reported AEs of eating disorders in the FDA database.
For example, in their testimony, the Natural Products Association (NPA) states the following: “In 2019, we submitted a FOIA request to the FDA to explore whether there were any adverse events from cases involving eating disorders and dietary supplements. The answer from FDA was zero.” (Access the testimony here: www.npanational.org/wp-content/uploads/2021/04/Oral-Testimony82.pdf).
The FDA and scientific organizations utilize CAERS to monitor for signals of an event deserving attention or rising to the level of concern and importance. Since there are no AEs associated with eating disorders in the FDA or US Military or other databases, there are no signals of concern.
If an AE is identified, then a causation assessment would be conducted. A causality assessment is an evaluation of the likelihood that a particular agent such as a prescription medication, dietary supplement, or other substance is the cause of an observed adverse AE.
Multiple criteria and algorithms may determine a causality relationship, however, no single one may be specific enough or complete for use in all conditions and circumstances. Therefore, it is important that the cardinal principles of determination or “diagnosis” be adhered to.
Principles of Causality Assessment
- evaluation of any temporal relationship,
- evaluation of any biological plausibility of the agent or product causing a reaction,
- conduct a challenge, de-challenge and re-challenge test.
In routine medical care and in clinical research studies, the physician or principal investigator assesses if a product being used may be related to a side effect that is being reported. These side effects are considered AEs, which then must be assessed for any relationship to any product being used by the individual. In research and practice, the de-challenge and re-challenge approach is used. The product is withdrawn from use for a specified amount of time and the subject observed for any change in signs and symptoms as well as subjective complaints, then the person is given the product again, to see if the side effect or AE disappeared when the product was withdrawn and then came back once the product was reintroduced (the re-challenge phase). Applying this scientifically accepted method for assessing causality, there is no data demonstrating that dietary supplements induce or cause an eating disorder, and there is no data demonstrating that avoiding dietary supplements prevents eating disorders from developing. For example see the NPAs description of causality assessment: www.npanational.org/wp-content/uploads/2022/11/NJ-A-3512-Testimony.pdf.
Suggesting that dietary supplements cause eating disorders is irresponsible and pulls attention away from the need for better mental healthcare.
Eating disorders are a global health concern that requires a multidimensional, multidisciplinary, evidence based, prevention and treatment effort. To minimize the cause of such a complex issue to any one behavior limits awareness and access to care. Furthermore, to attempt to impact legislation that bans access to any consumer item without any adverse events or signals identified is untruthful and misleading. There are tools available to assess if there any AEs associated with a dietary supplement that should be at least a first step in identify if any link exists before stating that a product is responsible, clearly the groups attacking the supplement industry did not take this first step.
For examples of how the industry trade group NPA is utilizing the above tactics to oppose legislation see the following: http://npainfo.wpenginepowered.com/wp-content/uploads/2023/06/hochul-veto-letter-060623v01.pdf and https://www.npanational.org/news/ca-governor-concurs-with-npa-and-vetoes-legislation-restricting-access-to-supplements/.
