Overview

United States of America (USA) is the largest market for dietary supplements across the globe. They are regulated by United States Food and Drug Administration (US FDA). With an evolved Regulatory regime, FDA does not review and approve dietary supplements based on their safety and efficacy before approval but rather evaluates them through adverse event monitoring and research. These products require a notification to FDA, 75 days prior to their marketing. FDA is also responsible for regulation of ingredients of the dietary supplements.

FDA Label Update:

FDA announced the new nutrition facts label for packaged foods to reflect new scientific information. The new nutrition facts label will make it easier for consumers to make informed decisions about the food they eat. Foods imported to the United States will need to meet these new requirements. The compliance date for the label update is July 26, 2018 for manufacturers with $10 million or more in annual food sales and July 26, 2019 for manufacturers with less than $10 million in annual food sales.

While tough regulations are evident in post-marketing surveillance, the key challenge lies in understanding the market dynamics in the country and making product launch accordingly. The regulations are updated regularly, and the applicants will require continuous track of updates to maintain compliance.

Headquartered in USA, Freyr offers Regulatory support keeping a track on updated adverse event reporting mechanism. We offer Regulatory Intelligence services to keep pace with changing regulations on time. Our experts review label and claims review, and ingredient analysis to ensure compliance.  

 

Freyr Expertise

  • Ingredient Assessment including NDI notification guidance
  • Label Compliance
  • Claims Review
  • Label Updates
  • GMP/cGMP Support
  • Organic Labeling Consultation

 

Freyr Advantages

  • End-to-end Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with different Health Authorities