By Kirstin Barber, JHBL Staff Member
The U.S. Food and Drug Administration (FDA) ensures the safety of various food, medical, and cosmetic products by regulating those that enter the U.S. market.[i] There are two types of weight loss supplements on the market – medications prescribed by doctors and over the counter supplements.[ii] The various medications prescribed by doctors go through extensive testing, studies, and require FDA approval prior to entering the market; however, the over the counter supplements do not require such approval.[iii] Over the counter dietary supplements became more readily available with the passage of the Dietary Supplement Health and Education Act of 1994, which allows supplements to enter the market without FDA approval as long as the label on the package is not misleading to consumers.[iv] The packaging must state that the product is not FDA approved, and that the product does not have the intent to cure, prevent or treat any ailment.[v]
The Federal Trade Commission (FTC) specifically regulates dietary supplements by monitoring product advertisements and marketing of the products.[vi] The FTC warns and attempts to educate the general public about false advertisements, and details specific things to look for when purchasing products such as harmful chemicals.[vii]
In June of 2021, the FDA approved its first drug for weight management since 2014, which offers new treatment for individuals struggling with weight management or loss; adding to the list of medications available for doctors to prescribe.[viii] This is one of the few effective weight management solutions.[ix] The medications aid individuals suffering from obesity and weight-related conditions such as type 2 diabetes.[x] They require monitoring for side effects and any other impacts it may have on the patient by health care professionals.[xi] There are five main drugs that have been approved by the FDA for prescription, meaning they are safe for consumption and meet all the federal safety standards.[xii] Of all of the medications approved by the FDA two of the medications are approved for use in children 12 and older, while the rest are strictly for use by adults only.[xiii] However, it is important to note the medications prescribed by doctors, and over the counter supplements are not intended to supplement healthy eating and physical activities; rather, the drugs are to assist the weight loss process.[xiv]
The dietary supplement market is a large market bringing in over 61 billion U.S. dollars in 2020, and has been growing significantly since the Covid-19 pandemic began.[xv] Supplements may contain harmful ingredients that can cause negative side effects on individuals if they are not adequately monitored by a doctor prior to taking them.[xvi] The regulation and testing of dietary supplements to meet safety standards is left to individual companies, who are also responsible for accurately labeling the products.[xvii] The FDA does not always receive prior notification of products entering the market until after consumers have already had access to them.[xviii] This leaves the FDA to act retro-actively by monitoring reports submitted by consumers and medical professionals once adverse and negative side effects have already occurred.[xix]
Additionally, the FTC has discovered many products on the market contain harmful ingredients that are not accurately listed on the ingredient labels.[xx] Research has shown that even when a product is recalled because of harmful ingredients, one in four Brazilian-Massachusetts women were still consuming the product a year later.[xxi] Research has also shown that even when the FDA ruled a specific ingredient had to be removed from products, it was still in 269 of 317 (84.9%) weight loss products as a hidden ingredient.[xxii] Hidden ingredients are contaminants that are added to enhance the supplement’s overall effects.[xxiii] The contaminants may not be listed on the ingredient label and can cause a lack of accuracy in the dosage of ingredients.[xxiv]
The availability of over-the-counter supplements to a vast market with little regulation has left it to the states to attempt to implement further regulation.[xxv] California and New York are currently in the process of presenting bills to prohibit the sale of over-the-counter weight loss supplements without a prescription to individuals under the age of 18 whether in person or online.[xxvi] Bills have been presented in other states including Massachusetts and New Jersey, and lawmakers are attempting to continue pushing to protect individuals from the harmful ingredients that are not thoroughly regulated by the FDA.[xxvii] The American Academy of Pediatrics has published research showing the damages that weight loss supplements and muscle building products can cause including liver damage, heart attacks, strokes, eating disorders, and even death.[xxviii] They continue to push for change as well.[xxix]
Even essential vitamins may contain harmful ingredients, and even when evidence informs consumers that supplements provide no benefit to the body, consumers are still likely to take them.[xxx] Some ingredients may cause more harm to individuals who are predisposed to specific health issues such as high blood pressure, and it is imperative to notify a doctor prior to taking any supplement no matter how ‘natural’ the ingredients.[xxxi]
There is a large market for dietary supplements such as cleanses, weight loss supplements, and performance enhancements which are often promoted with false advertisements and through big celebrities such as the Kardashians, Cardi B, and professional athletes.[xxxii] In 2019, Instagram and Facebook adjusted their platforms to restrict users under the age of 18 from seeing posts promoting weight loss products in an effort to protect younger users from the advertisement’s underlying messages.[xxxiii] However, advertisements and celebrity endorsed products continue to make it past the restrictions, further promoting weight loss products, adversely impacting young viewers.[xxxiv] Ultimately, the “lose 30 pounds in 30 days” mentality marketers promote, coupled with the accessibility of weight loss supplements give individuals the ability to support a market that is largely unregulated and promotes a negative societal ideal body image standard.[xxxv]
The FTC provides a resource for consumers to report products for false advertising as well as a place to report fraudulent claims on their website.[xxxvi] The FDA also provides ways to report adverse events such as bad reactions from products to their websites for consumers to aid in their regulating of products.[xxxvii]
The FDA and FTC continue to have limited reach through their regulations, leaving it to the states to assist in regulating over the counter supplements, yet it is ultimately up to the consumer to decide what products they use. It is always important to educate oneself on the companies making supplements and the ingredients used by those companies, and to always notify a doctor prior to taking any over the counter supplements.
[i]https://www.fda.gov/about-fda/what-we-do#:~:text=The%20Food%20and%20Drug%20Administration,and%20products%20that%20emit%20radiation
[ii] https://www.verywellfit.com/supplements-and-diet-pills-to-lose-weight-3495602
[iii] https://www.pennmedicine.org/updates/blogs/metabolic-and-bariatric-surgery-blog/2018/august/when-it-comes-to-diet-supplements-user-beware#:~:text=Are%20supplements%20FDA%2Dregulated%3F,or%20approval%20by%20the%20FDA..
[iv] https://ods.od.nih.gov/About/DSHEA_Wording.aspx
[v] Id.
[vi] https://consumer.ftc.gov/articles/truth-behind-weight-loss-ads
[vii] Id.
[viii] https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014
[ix] Id.
[x] Id.
[xi] Id.
[xii] https://www.verywellfit.com/supplements-and-diet-pills-to-lose-weight-3495602
[xiii][xiii] https://www.niddk.nih.gov/health-information/weight-management/prescription-medications-treat-overweight-obesity
[xiv] Id.
[xv] https://www.fortunebusinessinsights.com/dietary-supplements-market-102082
[xvi] https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements
[xvii] Id.
[xviii] Id.
[xix] Id.
[xx] https://consumer.ftc.gov/articles/truth-behind-weight-loss-ads
[xxi] https://cdn1.sph.harvard.edu/wp-content/uploads/sites/1267/2020/04/FINAL-Science-Summaries-2-19-19-1.pdf
[xxii] https://www.verywellfit.com/supplements-and-diet-pills-to-lose-weight-3495602.
[xxiii] https://www.health.harvard.edu/blog/whats-in-your-supplements-2019021515946.
[xxiv] Id.
[xxv] https://www.usnews.com/news/health-news/articles/2022-09-13/california-and-new-york-aim-to-curb-diet-pill-sales-to-minors.
[xxvi] Id.
[xxvii] Id.
[xxviii] Id.
[xxix] https://www.hsph.harvard.edu/striped/out-of-kids-hands/; https://cdn1.sph.harvard.edu/wp-content/uploads/sites/1267/2020/08/Dietary-Supplements-Regulation-Fact-Sheet-8-24-20.pdf
[xxx] https://www.nytimes.com/2016/11/15/well/eat/studies-show-little-benefit-in-supplements.html#:~:text=Americans%20spend%20more%20than%20%2430,benefit%20to%20those%20taking%20them..
[xxxi] https://www.health.harvard.edu/staying-healthy/are-weight-loss-drugs-worth-trying; https://www.verywellfit.com/supplements-and-diet-pills-to-lose-weight-3495602.
[xxxii] https://www.bbc.com/news/health-47090374.
[xxxiii] https://www.washingtonpost.com/lifestyle/wellness/instagram-and-facebook-ban-miracle-diet-posts-but-theres-much-more-work-to-do/2019/09/23/0829a872-de26-11e9-b199-f638bf2c340f_story.html
[xxxiv] Id.
[xxxv] Id.
[xxxvi] https://consumer.ftc.gov/articles/truth-behind-weight-loss-ads.
[xxxvii] https://www.fda.gov/food/dietary-supplements#:~:text=FDA%20regulates%20both%20finished%20dietary,conventional%22%20foods%20and%20drug%20products.
Kirstin Barber is a second-year law student and interested in family law. She currently works at a personal injury, social security disability and workers compensation law firm as a law clerk. She graduated from Roger Williams University with a Bachelor of Science in legal studies and psychology.
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