Dietary supplements in the USA: problematic trends

Area of Science:

• Pharmacology
• Regulatory Science
• Public Health

Background:

• The Dietary Supplement Health and Education Act of 1994 exempts manufacturers from premarket safety and efficacy testing.
• This regulatory loophole has persisted for over 25 years, creating challenges in oversight.
• Dietary supplements are classified as a subcategory of food, influencing regulatory standards.

Purpose of the Study:

• To examine problems within the dietary supplement industry.
• To analyze cases of misbranded or adulterated supplements in US federal courts.
• To identify trends in supplement contamination and regulatory violations between 2010 and 2019.

Main Methods:

• Review of US federal court cases (2010-2019) involving dietary supplements.
• Analysis of defendants charged with introducing misbranded food or drugs into interstate commerce.
• Identification of common contaminants found in adulterated supplements.

Main Results:

• Over half of the examined cases involved charges of misbranding or adulteration.
• Contaminants frequently included anabolic steroids, erectile dysfunction drugs, weight-loss agents, and psychoactive substances.
• The practice of 'home brewing' using bulk raw powders facilitates the addition of prescription drugs.

Conclusions:

• The current regulatory framework is insufficient to prevent the adulteration of dietary supplements.
• Significant public health risks are associated with the presence of undeclared and dangerous substances.
• Stricter enforcement and regulatory oversight are necessary to ensure supplement safety and efficacy.