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DIETARY SUPPLEMENT REGULATIONS

Skylie Wardrop

Created on December 1, 2021

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Transcript

Increase Regulation of Dietary Supplements

Skylie W. WRIT-116 FALL 2021

December, 2021

Introduction

  • Dietary Supplement Health and Education Act of 1994 (DSHEA)
    • Firm responsible for safety and support claims
  • Ingredients sold in the US before 1994 can be marketed with no evidence that they're effective or safe.

-Harvard Health Publishing

Why?

  • Bad for health
  • Don't tell people what's truly in the replacement
  • On market without an approval
  • Forced to list all side effects, cautions, and allergens
  • Exact amounts labeled

Want more information?

Info

Current Regulations

  • Manufacturers must notify the FDA prior to marketing new ingredient(s)
  • Reviewed for safety, not effectiveness or approval
  • Federal government enforces the post-market regulation of the supplement industry
  • More equipped to respond to problems than to prevent them

Chart of Regulations for different FDA regulated products

Many people take supplements because they believe they are safer than drugs (since they are “natural”), or work better.

  • Not Necessarily "Safer"
  • Linked to deaths
  • Many side effects as a result of taking them

Data

People that use dietary supplements

People that don't use dietary supplements

$30 billion

Amount Americans spend on dietary supplements per year

This graph shows the dietary supplements most people use and their age

Progress Was Made To Increase Regulations

FDA proposed a rule to help it test new ingredients:

  • Historical Data can be given to FDA to support ingredient safety

An article on Health Harvard suggested:

  • Data Clinical Trials= Better, Easy to Evaluate
  • Doesn't require companies to give unfavorable data to the FDA

Bibliography

Zelman, Kathleen M. “The Truth behind the Top 10 Dietary Supplements.” WebMD, WebMD, 30 June 2009, https://www.webmd.com/diet/features/truth-behind-top-10-dietary-supplements#7.

Krasny, Leslie. “Regulatory Issues: Meal Replacements -- Convenience or Compromise?” Foodprocessing.com, 3 Dec. 2004, https://www.foodprocessing.com/articles/2004/53/.

Trexler, Eric. “Supplement Regulation: Are Dietary Supplements Unregulated?” Stronger by Science, 13 Sept. 2021, https://www.strongerbyscience.com/supplement-regulation/.

Center for Food Safety and Applied Nutrition, FDA. “What You Need to Know about Dietary Supplements.” U.S. Food and Drug Administration, FDA, 29 Nov. 2017, https://www.fda.gov/food/buy-store-serve-safe-food/what-you-need-know-about-dietary-supplements.

Skerrett, Patrick J. “FDA Needs Stronger Rules to Ensure the Safety of Dietary Supplements.” Harvard Health, 2 Feb. 2012, https://www.health.harvard.edu/blog/fda-needs-stronger-rules-to-ensure-the-safety-of-dietary-supplements-201202024182.

Starr, Ranjani R. “Too little, too late: ineffective regulation of dietary supplements in the United States.” American journal of public health vol. 105,3 (2015): 478-85. doi:10.2105/AJPH.2014.302348