Rise in Audits Highlights Regulatory Focus on Supplement Safety

The U.S. Food and Drug Administration (FDA) has significantly ramped up its inspection efforts of dietary supplement facilities, conducting 600 audits in the fiscal year 2024. This marks a notable increase from the previous year’s 500 inspections, demonstrating the agency’s heightened focus on ensuring compliance with current good manufacturing practices (cGMPs) in the supplement industry.

The fiscal year 2024, which concluded on September 30, saw a particular surge in foreign inspections. The number of overseas audits more than doubled, rising from 41 in FY23 to 90 in FY24. Domestic inspections also saw a modest increase, climbing from 461 to 510.

These inspections are crucial for maintaining the integrity of dietary supplements, as they ensure adherence to the regulations outlined in 21 CFR Part 111. These guidelines are designed to guarantee that dietary supplement products consistently meet quality standards throughout their production process.

Robert Marriott, director of regulatory affairs at the American Herbal Products Association (AHPA), commented on the increase, stating, “Continued growth in the number of inspections is a good sign, but let’s not forget it’s measured against a much higher bar.” Marriott further emphasized the need for more resources and new approaches to meet the inspection goals set by the Food Safety Modernization Act, which mandates the inspection of domestic, non-high-risk food facilities at least once every five years.

Dr. Cara Welch, who oversees the FDA’s Office of Dietary Supplement Programs (ODSP), provided context for these numbers during a 2023 AHPA conference. She revealed that the FDA typically inspects about 5% of known facilities annually, which translates to approximately 500 to 600 facilities.

An FDA spokesperson underscored the importance of these inspections, stating, “Facility inspections play an integral role in the FDA’s oversight of dietary supplements.” The spokesperson also highlighted the agency’s strategic approach to resource allocation, aiming to make the most significant impact possible while collaborating with stakeholders to ensure a safe, well-manufactured, and accurately labeled dietary supplement marketplace.

This information, obtained by SupplySide Supplement Journal through a Freedom of Information Act request, sheds light on the FDA’s ongoing efforts to maintain high standards in the dietary supplement industry. As the supplement market continues to grow, these increased inspection efforts reflect the FDA’s commitment to consumer safety and product quality.

Commentary by YourDailyFit columnist Alice Winters:

The FDA’s ramped-up inspection efforts in the dietary supplement industry are a double-edged sword that warrants careful consideration. On one hand, this increase in audits signifies a commendable commitment to consumer safety and product integrity. With the supplement market’s explosive growth and the potential for adulteration or contamination, stringent oversight is crucial. The doubling of foreign inspections is particularly noteworthy, as it addresses the often-overlooked issue of imported ingredients and products.

However, we must scrutinize the efficacy of these inspections. While 600 audits may seem substantial, it represents a mere 5% of known facilities. This begs the question: Is this truly sufficient to ensure widespread compliance and safety? The FDA’s resource constraints are evident, and the agency’s strategic approach to maximizing impact is understandable. Yet, this limited reach may leave significant gaps in oversight.

Moreover, the focus on cGMP compliance, while important, may not address all concerns in the supplement industry. Issues such as misleading marketing claims, interactions with prescription medications, and long-term safety data often fall outside the scope of these inspections.

The industry’s response to these increased inspections is also worth noting. While reputable companies may welcome this scrutiny as a means to differentiate themselves in a crowded market, smaller firms might struggle with the costs and complexities of compliance. This could potentially lead to market consolidation, reducing consumer choice and potentially driving up prices.

From a consumer perspective, these inspections offer a layer of reassurance. However, the public should be aware that an FDA inspection does not guarantee a product’s efficacy or safety for individual use. Consumers must still exercise due diligence, consulting healthcare professionals and researching products independently.

Looking ahead, the FDA’s approach to supplement regulation may need to evolve. As Robert Marriott suggests, new approaches and resources are necessary to meet inspection goals. Perhaps a risk-based system, focusing more intensively on high-risk products or facilities with past violations, could optimize the use of limited resources.

In conclusion, while the increase in FDA inspections is a step in the right direction, it’s merely a part of the complex puzzle of ensuring supplement safety and efficacy. As the industry continues to grow and evolve, so too must our regulatory approaches, balancing consumer protection with industry innovation and accessibility.