We’ve all seen the ads, they sound incredible- take this over-the-counter weight loss supplement and the pounds will melt off. People claim the supplement was the reason significant amounts of weight were lost.
Why not try them?
Because they could be dangerous, interact with prescribed medications, and just do not work. As shared in past posts about the risks of taking dietary supplements, they may not even contain what is claimed and often have other items not represented such as stimulants, synthetic steroids and even sexual enhancement products, like Viagra.
Obesity has escalated to the point its estimated half the population will be obese by 2030 and one in four severely obese. As a result, weight loss products have exploded onto the market. By the end of 2024, the market for dietary supplements is projected to reach a total valuation of US $74.3 billion.
The Dietary Supplement Health and Education Act, passed in 1994, determined that over-the-counter products like supplements fall under the same regulation as food and therefore not subject to pre-market safety and effectiveness testing imposed on medications.
To identify products that are unsafe or contain unapproved ingredients, the FDA relies on post-market surveillance efforts. These include review of adverse event reports and consumer complaints, inspection of dietary supplement firms, and screening of imported products. It is a flawed and inexcusable mechanism to protect the public when lives are at stake.
The Food Safety and Modernization Act (FSMA), passed in 2011, brought the number of facility inspections up, but even then, the FDA is only required to review facilities identified as “high risk” once every three years and those identified as “low risk” once every seven years.
Additionally, a dietary supplement firm is obligated to report to the FDA events that require medical intervention to prevent death, hospitalization, or birth defect. When a product has the potential to cause serious adverse health consequences, the FDA can issue a Class 1 recall and take it off the market. Unless something catastrophic occurs, it is ultimately a voluntary process left up to the sole discretion of the company.
We all know how well that works.
While new regulations and guidelines are taking form as the landscape changes, it has proven to be slow compared to the speed of the market. As recently as March 4th, 2024, the FDA released new guidance intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and submit new dietary ingredient notifications (NDINs) to the FDA. But the reality of the risk of taking dietary supplements hasn’t changed much since that 1994 act went into effect. A new study highlighted just that; of 30 weight loss supplements, 80% had ingredients listed on the label that were absent from the product.
In a case series study published in JAMA Network Open, researchers purchased 30 dietary supplements from 12 companies that advertised discounts for military members. The products were analyzed to confirm whether they consisted of the ingredients listed on the supplement facts label. Research found 25 of the products had some type of inaccuracy, with some supplements missing ingredients, others containing ingredients not listed on the label and some containing substances listed on the U.S. Department of Defense’s prohibited dietary supplement ingredients list. None of the supplements in the study had an independent, third-party certification stating that they had been tested by an independent laboratory for quality or contaminants.
It’s no surprise that dietary supplements contain ingredients not shown on the label, as we previously shared in this post. Study after study shows that this is a persisting issue that may impact the health of those that consume dietary supplements, including weight loss supplements.
How does the FDA regulate dietary supplement labels?
The FDA has authority to enforce the Federal Drug and Cosmetic Act, including under other applicable federal laws (such as the Dietary Health Safety and Education Act of 1994, the Nutritional Labeling and Education Act of 1990, and the Fair Packaging and Labeling Act), and other regulations enacted by the Agency. The regulations encompass many aspects of how businesses operate, from manufacturing to claims about the product:
- Approving ingredients
- Mandatory labeling requirements
- False labeling
- Misbranding
- Proper manufacturing processes/GMPs
- What is considered credible scientific research for substantiation
When the FDA finds that a manufacturer has significantly violated FDA regulations, the FDA notifies the manufacturer in the form of a Warning Letter. Warning Letters are meant to alert manufacturers that they have violated FDA guidelines, which aren’t just suggestions. The FDA defines a warning letter as “a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations.”
Companies have a period of fifteen working days to respond to a FDA Warning Letter if they are found to be in violation of the guidelines surrounding the categories listed above. Their response should address the concerns in the letter, providing their reasoning and supporting information as to why they think the products are not in violation of the law. But even when the FDA becomes involved in these specific scenarios, it has been found that many companies largely ignore the letters.
In theory, failure to respond to the letter or adequately address the issues can result in a complete stop of the product’s manufacture and sales. The FDA can fine, seize property, recall, slap on criminal prosecutions, and partner with the Federal Trade Commission and other authorities to add additional charges and pursue enforcement.
While that sounds great on paper as a method of enforcement, the reality is a stark difference.
It has come to light that nearly 30% of dietary supplement manufacturers that have received FDA warning letters still have the products available for sale online over six years later. So where does that leave us, the consumers? Without a doubt, it puts us in a position of significant risk.
What can you do?
Unless your provider specifically tells you that you need to introduce a supplement to your routine, don’t. Even those that are most commonly used and have passed third party inspections and are considered “safe”, may have their share of risk.
They all promise incredible, but unrealistic results. As the old adage goes, “If it sounds too good to be true, it usually is.”
If they did work, medical providers would be encouraging their use. Our only goal is to help patients safely attain their goals. Why would we deny them this quick fix if they produced results?
Talk to your healthcare provider about realistic options and new medications on the market.
You can also use the Operation Supplement Safety scorecard to assess the safety of a supplement solely based on the label claims.
Supplements should have a seal on the product label from a reputable third-party organization. Some examples include the seals below:
If you do decide to start using a supplement, weight loss or otherwise, speak to your provider before starting any regimen.
-https://www.futuremarketinsights.com/reports/dietary-supplements-market#:~:text=The%20global%20dietary%20supplement%20market%20size%20is%20expected,reach%20a%20total%20valuation%20of%20US%24%2074.3%20billion.
– https://www.lachmanconsultants.com/2016/08/dietary-supplement-manufacturers-are-you-ready-for-fda/#:~:text=The%20definition%20of%20%E2%80%9Cfood%E2%80%9D%20includes,risk%E2%80%9D%20once%20every%20seven%20years
-https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-final-guidance-new-dietary-ingredient-notification-procedures-and-timeframes
-https://foodsupplements.freyrsolutions.com/blog/us-food-and-dietary-supplements-regulatory-perspectives-on-2024-emerging-trends
-https://www.reuters.com/article/idUSKBN1YM2IN/#:~:text=(Reuters%20Health)%20%2D%20A%20new,24.2%25%20will%20be%20severely%20obese.
-https://www.opss.org/opss-scorecard-check-your-dietary-supplement
-https://www.healio.com/news/endocrinology/20240502/most-weight-losspromoting-dietary-supplements-contain-inaccurate-ingredient-labels
-jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496
-ods.od.nih.gov/factsheets/WeightLoss-HealthProfessional/
-ods.od.nih.gov/HealthInformation/DS_WhatYouNeedToKnow.aspx.
-https://consumer.healthday.com/fda-warning-letters-targeting-supplement-products-not-always-heeded-2657745372.html
-fda.gov/Food/DietarySupplements/ProductsIngredients/
-fda.gov/Food/DietarySupplements/UsingDietarySupplements/
-gao.gov/assets/660/653113.pdf
-https://ods.od.nih.gov/factsheets/WYNTK-Consumer/
-fda.gov/safety/recalls/ucm165546.htm.
-health.com/health/article/0,,20411392,00.html
-https://www.fda.gov/food/compliance-enforcement-food/warning-letters-related-food-beverages-and-dietary-supplements
-https://www.fda.gov/food/cfsan-constituent-updates/fda-sends-warning-letters-multiple-companies-illegally-selling-adulterated-dietary-supplements
-https://www.consumerreports.org/cro/magazine/2012/09/10-surprising-dangers-of-vitamins-and-supplements/index.htm