Dietary Supplements and the Food Safety Modernization Act: Today and Tomorrow

The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA). It requires FDA to implement a sweeping array of new regulations and enforcement policies, intended to better ensure the safety of food products marketed in the United States, including dietary supplements.

FSMA has far-reaching implications for companies that manufacture, distribute, import, or market dietary supplement products or ingredients for the U.S. market. Most FSMA requirements apply to entities that manufacture, process, pack, receive, or hold “food,” which includes “dietary supplements.”(1) This means that nearly all of the FSMA’s “food” provisions apply equally to dietary supplements.

However, there are two key areas in which FSMA requirements for dietary supplements are distinctive: 1) dietary supplement companies are exempt from FSMA provisions requiring food facilities to implement written, facility-specific hazard analysis and control plans, provided that their dietary supplement products are manufactured in compliance with the rigorous GMP standards,(2) and 2) dietary supplement companies are subject to new standards regarding new dietary ingredient (NDI) notification.

FSMA impacts dietary supplement companies in a number of ways.

• Requires FDA to publish NDI draft guidance
• Expands FDA’s enforcement tools, giving it authority to mandate product recalls and suspend facility registrations, and broader authority to investigate and detain products
• Amends facility registration procedures and expands FDA access for facility and recordkeeping inspections
• Expands requirements imposed on foreign supplier imports

Key Developments in 2011

Dietary supplement companies should be aware that while FSMA is a new law that will not be fully implemented for a number of years, some FSMA provisions already took effect last year. (See the table attached.)

Implementing FSMA in 2012, 2013

FSMA requires FDA to complete a number of significant tasks to implement FSMA during 2012 and 2013, all of which will have significant implications for dietary supplement companies.

Deadline: January 2012

• Designate “high-risk” foods requiring additional recordkeeping
• Issue guidance to assist importers in developing foreign supplier verification programs
• Promulgate rules for the content of foreign supplier verification programs

Deadline: July 2012

• Establish a program providing for expedited review and importation of goods whose importers have voluntarily agreed to participate in a voluntary qualified importer program

Deadline: January 2013

• Issue a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold “high-risk” foods

Companies are advised to review current compliance policies and procedures in view of FDA’s expanded investigative and enforcement powers, as well as the wide range of FSMA mandates for the establishment and maintenance of systematic documentation and recordkeeping. Further, dietary supplement companies have the opportunity to influence FSMA requirements that ultimately will apply to their products and business practices. They can be engaged in rulemaking and policy development by submitting comments to FDA on proposed rules and guidance documents the agency plans to publish during 2012 and 2013. Dietary supplement companies can also keep their government representatives informed about how FSMA regulations are likely to affect them and the consumers of their products.

References

1. See FDCA § 201(ff) (defining “dietary supplements” as “food”) 

2. Dietary Supplement cGMP requirements are promulgated at 21 CFR Part 111

3. FDA, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” (July 2011), available at www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm (published at 76 Fed. Reg. 39111 (July 5, 2011)) 

4. “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues;” Availability; Extension of Comment Period, 76 Fed. Reg. 55927 (Sept. 9, 2011). (Extending the comment period regarding the FDA’s draft NDI guidance by 60 days to Dec. 2, 2011) 

5. FDA News Release, “FDA launches consumer-friendly Web search for consumer during recall,” (Apr. 4, 2011), available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249437.htm

6. “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” 76 Fed. Reg. 25538 (May 5, 2011) (amending 21 CFR Part 1) 

7. Id. at 25538-39 

8. FDA, “Guidance for Industry: What You Need to Know About Administrative Detention of Foods,” (Oct. 2011), available at www.fda.gov/Food/guidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodDefenseandEmergencyResponse/ucm276871.htm

9. FDA News Release, “FDA: U.S. Marshals seize food products at Illinois warehouse,” (Oct. 19, 2011), available at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm276245.htm  

10.  Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012, 76 Fed. Reg. 45820 (Aug. 1, 2011) 

11. FDA, “Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act,” (Sept. 2011) at Section III, available at www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodSafety/ucm274176.htm 

12. Id.   

13. Information Required in Prior Notice of Imported Food, 76 Fed. Reg. 25542 (May 5, 2011) (amending 21 CFR Part 1)