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If the New Regulation on the Dietary Supplement Industry were to pass, would your Products be Compliant?

Summary: As we have discussed in previous blogs, Dietary Supplements are a booming industry, valued at $54 billion in the USA alone. Despite their growing popularity, however, the USA has comparatively limited regulations surrounding this industry. The dangers of supplements lacking oversight become apparent: for instance, in 2021, Lori McClintock, the wife of U.S. Rep Tom McClintock, died after consuming the white mulberry leaf, an herbal remedy which is widely used and is generally considered safe. To improve the safety and efficacy of supplements, Senators Richard Durbin (D-IL) and Mike Braun (R-IN) have introduced the Dietary Supplement Listing Act of 2022. In this article we will look at the history of supplement regulations in the USA, the forecasted change, and ask, is your company prepared? 

Over 4 in 5 Americans (86%) say they consume a supplement every day — up 34% in the last decade (from 52% of people reporting they take supplements in 2012) (CISION, 2019; Kantor et al., 2016). This being said, the USA’s regulations surrounding the dietary supplements industry have fallen behind. In fact, the last set of laws that set regulations was the Dietary Supplement Health and Education Act of 1994 (DSHEA). Needless to say, in the twenty-seven years since this law was passed things have changed, and recently, there has been an explosion of media reports regarding the potential dangers of the current system. For instance, in the past year cardiologists have warned that supplement consumption is leading to a drastic increase in heart arrhythmias in people under 30, particular supplements (such as the bodybuilding aid OxyELITE Pro) have been found to cause liver damage, and specific high profile cases have become more abundant, such as the death of a California congressman’s wife, Lori McClintock after ingesting an herbal remedy (Akhtar, 2022; Larson, 2022; Young, 2022). 

In light of these reports, consumer awareness groups and Congress have taken notice — in April 2022 U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022. This act aims to “improve the transparency and availability of information regarding dietary supplements” by requiring manufacturers to provide the FDA with a mandatory product listing (MPL) (S. 4090 – 117th Congress, 2022). 

mandatory product listing

The explosion of the Dietary Supplement Industry

This bill’s proposal is particularly timely because not only has the Dietary Supplement market grown substantially in recent years, but there has also been a shift in the way these products are approached by the advertising sector and regarded by the general public. Proven to be profitable, Dietary Supplement manufacturers have poured money into marketing their products — spending approximately $900 Million USD on advertising in 2021 alone (Jia, Cameron & Linder, 2022). While marketing itself is not inherently problematic, enticing campaigns can lead consumers to consume unneeded, or even dangerous combinations of supplements. In fact, only about a quarter (24%) of Americans who said they consume daily supplements are actually diagnosed with a nutritional deficiency (Cision, 2019). 

These numbers were only bolstered by the COVID-19 pandemic, during which there was a drastic increase in interest and use of supplements worldwide (Aysin & Urhan, 2021). Overall, wellness trends became more prominent during the Coronavirus pandemic, with 54% of consumers saying they would be changing their shopping and spending behaviors to emphasize health and wellness (Redsky Strategy, 2022). 

Supplement Safety & Efficacy

With so many Americans consuming supplements, one of the things this new bill asks is, what are these supplements actually doing? Do they produce an effect? Are they safe? 

If passed, the Dietary Supplement Act of 2022 would work to make these questions easier to answer by establishing a mandatory product listing system. Under such a system, manufacturers would be required to list their products with the FDA. As a result, the FDA would have “insight into new ingredients or new product types being introduced to the market, as well as where products are being manufactured,” explained Dr Cara Welch, President of the FDA’s Office of Dietary Supplement Programs (ODSP) (Long, 2022).

From there, the FDA would give listed products a listing number that “may apply to multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives or flavorings, including dietary supplements offered in a single package size or in multiple package sizes” (Long, 2022). 

This list would be made available to consumers, providing greater visibility overall. Furthermore, an MPL system would streamline the FDA’s oversight capability of the industry, as, “if a product is introduced to the market but does not match the listing in a public database, the FDA would be able to identify it” (Long, 2022). 

Proponents of the new bill say that empowering consumers and the FDA with this information is vital as currently, dietary supplements are patrolled on an ad hoc system — warnings are only issued when consumers report an issue. An MPL system would enable consumers to preemptively check ingredients for any potentially harmful ingredients. This could be especially impactful because combining certain supplements and/or prescription medications are known to cause complications. For instance, some vitamins (like magnesium and calcium) can make it harder for your body to absorb others (so these supplements should be taken at different time points). In the worst case scenario, combining vitamins or vitamin+prescription medication can actually cause bodily damage: warfarin (a prescription blood thinner), ginkgo biloba (an herbal supplement), aspirin, and vitamin E (a supplement) are all blood thinners, and thus, combined, can raise one’s risk of internal bleeding or stroke (FDA, 2022). 

“A 2015 study found that about 23,000 emergency room visits every year are caused by dietary supplements” – Larson (2022)

Another reason why many experts consider an MPL to be a crucial next step in the regulatory process, is that multivitamins are the most popular type of dietary supplement product [Figure 2] (CRN, 2019). These ‘blends’ are often the most attractive product for manufacturers companies to produce, as these formulations are considered proprietary, and the intellectual property (IP)  of which are protected by the statute and attendant regulations (see 21 CFR 101.36) of the DHEA (CRN, 2021). This being said, just as it can be harmful for people to consume multiple vitamins products without considering the combination of them, it has been found that many of the supplements that are sold as multivitamin blends can cause damage, particularly to the liver (Ronis, Pedersen & Watt, 2018).

most popular supplements

Figure 2. Ten Most Popular Supplements Among American Adults surveyed in 2019 (CRN, 2019).

What’s Next

In light of the increased consumption of supplements, and the increased awareness of their potential dangers or inefficiencies, the Dietary Supplement Act of 2022 has become a hot topic. While it is still unknown whether the proposed bill will pass, it has raised the alarm over the lack of current regulations, and it is highly likely that another version of the bill will be proposed

Although some manufacturers have criticized the bill, pointing to the substantial cost and hassle of creating an MPL, many say it is an opportunity to differentiate their products, a way to instill confidence in the safety and efficiency of their products, and create a committed customer base. 

According to Nutritional Outlook, consumers very much view supplements as a key tool in their health and wellness plans. Regardless of the bill, consumers are taking the quality and efficacy of supplements more seriously and demanding to see scientific-based claims. Based on the ADM report, “When considering nutritional supplements, 59% of global consumers want to see scientific evidence supporting supplement efficacy.”

Here at InVivo Biosystems we provide customizable studies, so that you can introduce your product with science-backed efficacy claims and quicken the preclinical process. Reach out to one of our experts today to see how we can support your product goals. 

To read more about the Dietary Supplement Act of 2022, click here. 

Further nutraceutical reading: 

References: 

  1. CISION (2019). Poll finds 86% of Americans Take Vitamins or Supplements https://www.prnewswire.com/news-releases/poll-finds-86-of-americans-take-vitamins-or-supplements-yet-only-21-have-a-confirmed-nutritional-deficiency-300779470.html
  2. Kantor, E. D., Rehm, C. D., Du, M., White, E., & Giovannucci, E. L. (2016). Trends in Dietary Supplement Use Among US Adults From 1999-2012. JAMA316(14), 1464–1474. https://doi.org/10.1001/jama.2016.14403
  3. Council for Responsible Nutrition (CRN) (2019). Dietary Supplement Use Reaches All Time High. https://www.crnusa.org/newsroom/dietary-supplement-use-reaches-all-time-high
  4. Boston Medical Center (2015). BMC finds adults do not report dietary supplement use to physicians. Medical Press. https://medicalxpress.com/news/2015-05-bmc-adults-dietary-supplement-physicians.html
  5. Larson, A. (2022). Death of congressman’s wife points to dangers of dietary supplements, CBS News. https://www.nbcnews.com/think/opinion/death-rep-tom-mcclintock-wife-points-supplements-dangers-rcna45009
  6. Young, S. (2022). Congressman’s wife died after taking white mulberry leaf, an herbal remedy, NBC News, https://www.yahoo.com/news/congressman-wife-died-taking-white-222811064.html?guccounter=1
  7. Akhtar, A. (2022). A cardiologist says she’s seeing a rise in 20-somethings with heart arrhythmias caused by herbal supplements, Insider, https://www.insider.com/cardiologist-supplements-causing-heart-arrhythmias-in-young-people-2022-9
  8. The Dietary Supplement Listing Act of 2022, S. 4090, 117th Cong. (2022). https://www.congress.gov/bill/117th-congress/senate-bill/4090/text
  9. Jia J, Cameron NA, Linder JA. (2022). Multivitamins and Supplements—Benign Prevention or Potentially Harmful Distraction? JAMA ;327(23):2294–2295. doi:10.1001/jama.2022.9167
  10. Aysin, E. Urhan, M. (2021). Dramatic Increase in Dietary Supplement Use During Covid-19, Current Developments in Nutrition 5(2), pp. 207, https://doi.org/10.1093/cdn/nzab029_008
  11. Redsky Strategy (2022). 2022 Wellness Trends: How Brands and Consumers Are Responding to the Impacts of COVID, redsky strategy, https://redskystrategy.com/2022-wellness-trends-how-brands-and-consumers-are-responding-to-the-impacts-of-covid/
  12. Long (2022). FDA official defends the proposed mandatory product listing for supplements. New Hope Network, https://www.newhope.com/regulatory/fda-official-defends-proposed-mandatory-product-listing-supplements
  13. Ronis, M., Pedersen, K. B., & Watt, J. (2018). Adverse Effects of Nutraceuticals and Dietary Supplements. Annual review of pharmacology and toxicology, 58, 583–601. https://doi.org/10.1146/annurev-pharmtox-010617-052844
  14. Grebow, Jennifer (2022). 2022 Consumer Trends: People will still turn to dietary supplements, nutrition for preventative health in 2022. Nutritional Outlook, Feb. 2022. https://www.nutritionaloutlook.com/view/2022-consumer-trends-people-will-still-turn-to-dietary-supplements-nutrition-for-preventative-health-in-2022
 

About the Author

 

 
 
 
Alexandra is a Content Marketing Specialist and Grant Writer for InVivo Biosystems. She graduated from the University of St Andrews in 2020 where she earned a Joint MA Honours Degree in English & Psychology/Neuroscience with BPS [British Psychology Society] Accreditation. She has worked as a research assistant, examining the LEC’s (lateral entorhinal cortex) involvement in spatial memory and integrating long term multimodal item-context associations, and completed her dissertation on how the number and kinds of sensory cues affect memory persistence across timescales. Her hobbies include running, boxing, and reading.

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