Ensuring Compliance In The U.S. Dietary Supplement Industry: Key Regulations And The Role Of Toxicology Assessments

The dietary supplement industry in the U.S. continues to grow rapidly, with increasing consumer demand for vitamins, minerals, and other supplements to support health and wellness. However, businesses planning to enter this market must adhere to strict regulations to ensure their products are both safe and legally compliant.

The Food and Drug Administration (FDA) oversees dietary supplements, enforcing safety, labelling, and manufacturing standards. Non-compliance can result in serious consequences, including product recalls, fines, or removal from the market. This guide provides an updated overview of the essential regulatory requirements for selling dietary supplements in 2025 and beyond, highlighting the critical role of toxicology risk assessments and regulatory services.

Understanding Dietary Supplements

According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are products intended to supplement the diet. They may include:

• Vitamins & minerals
• Herbs & botanicals
• Amino acids
• Enzymes & probiotics
• Other nutritional substances

Since dietary supplements are regulated differently from conventional foods and prescription drugs, businesses must carefully follow industry-specific regulations.

Regulatory Requirements for Selling Dietary Supplements in the U.S.

1. Compliance with DSHEA

The DSHEA remains the primary regulatory framework governing dietary supplements. Manufacturers and distributors must adhere to the following key requirements:

• Product Labelling: Labels must include a Supplement Facts panel detailing ingredients and serving sizes.
• Ingredient Safety: Manufacturers must ensure ingredient safety and exclude unapproved or unsafe ingredients.
• Claims and Statements: Claims must be truthful and non-misleading. Supplements cannot claim to cure or prevent diseases.

2. Adherence to FDA Good Manufacturing Practices (GMPs)

GMPs ensure that dietary supplements are consistently produced and controlled according to quality standards. Key requirements include:

• Facility cleanliness & sanitation
• Proper ingredient sourcing
• Equipment maintenance
• Employee training & compliance

Failure to comply with GMPs can result in product recalls and penalties.

3. Submission of New Dietary Ingredient Notification (NDIN)

If a supplement contains an ingredient not marketed in the U.S. before October 15, 1994, the manufacturer must submit an NDIN to the FDA at least 75 days before the product’s launch.

4. Notification of Structure/Function Claims

Manufacturers must notify the FDA within 30 days of launching a supplement containing structure/function claims (e.g., “supports immune health”).

5. Proper Labelling Compliance

Dietary supplement labels must include:

• Product name & form (capsule, tablet, powder, etc.)
• Net quantity of contents
• Supplement Facts panel with ingredient details
• Serving size & daily values
• Manufacturer’s name & contact details for adverse reaction reporting
• Allergen warnings (if applicable)

Labels must not mislead consumers into believing the product is a drug or cure.

6. Avoidance of Disease Claims

Supplements cannot claim to:

• Diagnose medical conditions
• Cure or treat diseases
• Prevent illnesses

Instead, manufacturers can use structure/function claims such as:

• “Supports immune health” instead of “Prevents infections”
• “Promotes joint flexibility” instead of “Treats arthritis”

7. Implementation of Quality Control and Testing

To ensure product safety and efficacy, manufacturers must:

• Verify ingredient identity and potency
• Test for contaminants such as heavy metals and pesticides
• Maintain accurate ingredient concentrations

Third-party testing enhances credibility and consumer trust.

8. Reporting of Serious Adverse Events

Manufacturers must report any serious adverse events related to their supplements to the FDA, ensuring consumer safety and regulatory transparency.

9. Compliance with State-Specific Regulations

Some states impose additional regulations beyond federal requirements. Businesses should review state laws before distributing products nationwide.

10. Keeping Up with Regulatory Changes

The dietary supplement industry is continually evolving. To remain compliant, businesses should:

• Subscribe to FDA and FTC updates
• Join industry organizations like the Council for Responsible Nutrition (CRN)
• Consult regulatory experts when launching new products

Key Updates to U.S. Dietary Supplement Regulations in 2025

1. Updated "Healthy" Nutrient Content Claim: The FDA has revised the definition of the "healthy" claim, requiring specific nutrient compositions and adherence to limits on saturated fat, sodium, and added sugars.
2. Ban on Red No. 3: The FDA has prohibited erythrosine (Red No. 3) in dietary supplements, with a compliance deadline of January 15, 2027.
3. Clarification on Dietary Supplement Definition: A proposed rule in May 2025 aims to clarify which ingredients qualify as dietary supplements.
4. NIH Strategic Plan for Dietary Supplements (2025–2029): Research priorities now focus on public health importance and knowledge gaps.
5. Updated Dietary Guidelines for Americans: The USDA and HHS continue to refine dietary guidance across all life stages.
6. Guidance on New Dietary Ingredient (NDI) Notifications: The FDA has outlined clearer procedures for submitting NDIs.

The Role of Toxicology Risk Assessments in Dietary Supplements

Toxicology risk assessments are crucial in evaluating the safety of dietary supplement ingredients. These assessments help in:

• Identifying potential toxicological concerns
• Determining safe dosage levels
• Assessing ingredient interactions
• Ensuring compliance with regulatory standards

By conducting thorough risk assessments, businesses can minimize health risks and build consumer trust.

Maven's Regulatory Services for Dietary Supplements

Maven provides end-to-end regulatory support to ensure dietary supplement compliance, including:

• Toxicology Risk Assessments for ingredient safety evaluations
• Regulatory Strategy Development to navigate complex FDA and global guidelines
• Labelling & Claims Review to ensure compliance with DSHEA and FDA requirements
• GMP Auditing & Compliance Support to maintain manufacturing quality
• Adverse Event Reporting Assistance to fulfil post-market regulatory obligations

By partnering with Maven, dietary supplement businesses can confidently navigate regulatory challenges and maintain compliance while delivering high-quality products to consumers.

Conclusion

Entering the U.S. dietary supplement market presents significant opportunities but also demands strict regulatory adherence. By following FDA regulations, conducting thorough toxicology risk assessments, and leveraging expert regulatory services like those provided by Maven, businesses can ensure compliance, uphold product quality, and build lasting consumer trust.

Staying informed about evolving regulations and proactively addressing compliance challenges will be key to success in the ever-expanding dietary supplement industry. For expert guidance on regulatory requirements, consider consulting with Maven’s team of professionals specializing in dietary supplement compliance and safety assessments.