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Introduction
Dietary supplements have become an integral part of millions of individuals' wellness routines and lifestyle improvements. They are often utilized by consumers seeking to enhance their health, mntn optimal wellness or support challenging lifestyles. Some individuals turn to lifestyle supplements that promise quick results for concerns they may prefer not to discuss with healthcare professionals, such as sexual dysfunction or excessive weight gn. Others m to improve athletic performance. These products frequently clm to provide fast-acting, side-effect-free, safe, and all-natural herbal solutions. However, many of these are adulterated with undeclared prescription drugs or their unapproved synthetic analogs.
USP's Efforts in Detecting Supplement Adulteration
The prevalence of dietary supplement adulteration necessitates stringent measures for detection. Within the categories of sexual enhancement, weight loss, and sports performance improvement supplements, many products may contn prohibited substances rather than being free from them. The USP Expert Panel has developed a proposed General Chapter 2251, titled Adulteration of Dietary Supplements with Drugs and Drug Analogues, which outlines analytical methodologies for identifying adulterants in lifestyle supplements.
Focus on Sexual Enhancement Supplement Adulteration
This chapter primarily targets detection methods for adulterated sexual enhancement products. These items pose a significant threat to consumers who may seek alternative treatments due to health contrndications, such as heart conditions, for FDA-approved erectile dysfunction medications that are phosphodiesterase type 5 PDE5 inhibitors.
Cautiousness with Unapproved Additives
Not only do dietary supplement adulterants include traditional pharmaceuticals like sildenafil Viagra and tadalafil Cialis, but also their analogues chemical derivatives or cheaper synthetic intermediates. Some compounds are withdrawn from the market due to safety concerns, while others have never undergone trials. Unknown toxicological properties of these substances pose grave risks to public health.
Chapter Development
The draft of 2251 was developed by a team of volunteer experts with experience in dietary supplements, pharmaceutical analysis, enforcement, regulation, and academic research. The chapter underwent a 90-day comment period that ed on July 31st, providing an opportunity for interested parties to contribute their insights before it is finalized.
Revision for Future Updates
The General Chapter 2251 will be periodically updated as required. Subsequent revisions are anticipated to include methods for detecting adulteration in the weight loss and sports performance enhancement categories.
USP's Role
This resource serves dietary supplement manufacturers committed to producing high-quality products, regulators ming to protect public health by ensuring product safety, and interested parties seeking to collaborate on discussions regarding the chapter and its application. USP encourages all stakeholders to join the conversation at the Workshop on Adulteration and Fraud in Food Ingredients and Dietary Supplements organized by USP, American Botanical Council, and National Center for Food Protection and Defense.
Proposed General Chapter 2251 is a crucial tool for manufacturers looking to produce quality products, as well as regulators eager to safeguard public health through stringent product quality measures. It offers methodologies that can d in the identification of adulterated supplements prior to their distribution to consumers.
Contact Information
Contributors:
Diane McCarthy Michael Rashed Yognandan Pandya
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