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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Vitamins01:30

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Prohibited Contaminants in Dietary Supplements.

Neilson M Mathews1

  • 1Lehigh Valley Health Network, Allentown, Pennsylvania.

Sports Health
|August 30, 2017
PubMed
Summary

Athletes face risks from contaminated dietary supplements, leading to adverse events and inadvertent doping. Improved education and third-party certified products can mitigate these dangers.

Area of Science:

  • Sports Medicine
  • Nutritional Science
  • Pharmacology

Background:

  • Unregulated dietary supplements pose significant risks to athletes.
  • Athletes are susceptible to adverse medical events and inadvertent doping due to supplement use.

Purpose of the Study:

  • To review the prevalence and nature of contamination in dietary supplements.
  • To assess the risks associated with dietary supplement use in athletes, including doping violations.

Main Methods:

  • A comprehensive literature review of multiple databases (Clinical Key, MEDLINE, PubMed) from 2012 to 2017.
  • Searches included terms related to dietary supplements, contamination, and athlete doping.
  • References of relevant articles were also reviewed.
Keywords:
dietary supplementsinadvertent dopingprohibited contaminants

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Main Results:

  • Dietary supplements in the U.S. are frequently contaminated due to poor manufacturing and intentional adulteration.
  • Supplements marketed for weight loss and muscle building present a higher risk of contamination with banned substances.

Conclusions:

  • Legislation is needed to improve dietary supplement regulation and protect athletes.
  • In the interim, enhanced athlete and medical staff education and the use of third-party certified products are crucial for risk mitigation.