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Reviewing the 2022-2023 FDA Updates and Guidelines for Supplements



The dietary supplement industry is booming. The global supplements market size was estimated at USD 164.0 billion in 2022 and is projected to grow at a compound annual growth rate of 9.0% from 2023 to 2030 (Dietary Supplement Market Size, Share & Trends Analysis Report).


In the US market, the FDA plays a pivotal role in shaping its future. As we review the 2022-2023 updates from the FDA, brand owners, marketers, and researchers alike must stay informed and adapt to these changes. This article will guide you through the significant FDA updates in the supplement industry, emphasizing their impact and what they mean for the industry and your brand.


1. A New Directory for Ingredients (March 2023)

To enhance transparency and information accessibility, the FDA launched a comprehensive directory of ingredients used in dietary supplements. This initiative not only aids consumers in making informed choices but also supports manufacturers in ensuring compliance with regulatory standards.


2. Warning Against Cardiovascular Disease Claims (November 2022)

The FDA's issuance of warning letters to companies claiming their supplements could treat cardiovascular disease marks a significant step in combating misleading health claims. This action underlines the agency's commitment to protecting consumers from potentially harmful or unproven assertions.


3. Guidance on NAC Products (August 2022)

The FDA's final guidance on the enforcement discretion for certain N-acetyl cysteine (NAC) products reflects its nuanced approach to supplement regulation. This guidance helps clarify the regulatory landscape for manufacturers and consumers regarding NAC-containing supplements.


4. Educational Initiatives for Dietary Supplements (June 2022)

With the launch of a new education initiative, the FDA aims to deepen public understanding of dietary supplements. This effort highlights the importance of informed decision-making for both consumers and healthcare professionals.


5. Draft Guidance on NDI and Adulterated Supplements (May 2022)

The FDA's draft guidance on New Dietary Ingredient (NDI) enforcement discretion and action against companies selling adulterated supplements showcases its vigilant stance on supplement safety and quality.


The Structural Transformation of 2023

Perhaps the most significant development this year is the FDA's reorganization into a unified Human Foods Program (HFP), which includes oversight of supplements. This restructuring enhances the FDA's risk management framework and develops new surveillance methods. The establishment of the Office of Food Chemical Safety, Dietary Supplements, and Innovation is a testament to the growing complexity and importance of the supplement industry.


The Impact of These Updates

These updates signify a move towards greater regulatory clarity, safety, and innovation in the supplement industry. For brand owners, marketers, and researchers, understanding these changes is crucial in navigating the market effectively and ensuring compliance. For consumers, these developments offer reassurance of the FDA's commitment to safeguarding their health and well-being.


It should also be noted that these changes reflect the growing consumer interest in the safety and efficacy of their supplements. Regulatory oversight and updates are designed to protect consumers. Make sure you align your business goals with this in mind or else your approach towards future updates could hinder your business success. 


Stay tuned for more insights and updates on the supplement industry. Remember, knowledge is not just power; it could mean the difference between compliance and a warning letter. 


Curious about how you stay compliant with the supplement FDA updates?

Reach out to our team and learn how you can get research-backed claims to stay ahead of the industry changes.

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