Why you should buy this report?

The probiotics market is expected to surpass an estimate of US$9.5 billion by 2027, making the probiotics industry an ideal business opportunity for probiotic manufacturers or distributors in the US. In the United States, growing consumer awareness of the connection between diet and health is driving the demand for probiotics and dietary supplements that enhance health and provide basic nutrition.

This report is a comprehensive resource for studying end-to-end regulations on probiotics in the United States of America (USA), where the food & supplements market is growing rapidly over the years.

The objective of this report is to enable a Regulatory go-to-market strategy and ensure compliance.

Table of Contents

1. LIST OF ABBREVIATIONS
2. REGULATORY OVERSIGHT – PROBIOTICS
3. FDA’S POSITION ON PROBIOTICS ALONG WITH THE GUIDANCE STRATEGY TO LAUNCH A PROBIOTICS
   1. Submission Requirements
   2. Timelines
   3. Documents to be Submitted
   4. Submission Modes
   5. Process after Submitting the Premarket Notification for a New Dietary Ingredient to the FDA
4. FLOWCHART FOR THE REGULATORY ANALYSIS OF FOOD INGREDIENT UNDER DIETARY SUPPLEMENT HEALTH & EDUCATION ACT OF 1994
5. LABELING REQUIREMENTS OF PROBIOTICS
   1. Mandatory Labelling requirements for Probiotics as Dietary Supplements
   2. Regulatory controls on dietary supplement label in USA
   3. Required dietary supplement label statements and label panels
   4. Requirement of label statements on Principal Display Panel (PDP):
   5. Required label statements on the information panel
   6. Required label statements on any other/additional panel
   7. Requirements to declare Statement of Identity on label:
   8. Requirement to declare Net quantity of Contents on the label:
   9. Requirements to place Supplement Facts Panel on the label:
   10. Requirements to declare List of Ingredients on label:
   11. Requirements to declare Name and place of Business of Manufacturer, Packer or Distributor:
   12. Requirements to declare Direction of use on the label
   13. Requirements to declare Warning Statement on the label
   14. Requirements to declare Country of origin on the label
   15. Requirements for DSHEA disclaimer statement on the label:
   16. Some mandatory labeling requirements of Probiotics in the USA
   17. Quality and Safety Standards for Probiotics
6. CLAIMS FOR DIETARY SUPPLEMENTS IN PROBIOTIC STATURE
   1. Structure/Function Claims for Probiotic Conventional Foods or Dietary Supplements
   2. Health Claims for Probiotics Conventional Foods or Dietary Supplements
   3. Criteria for Choosing Structure / Function Claims or Health Claims
   4. Evidence Documents Required for Making Claims
7. APPLICABLE REGULATIONS AND REQUIREMENTS FOR THE ADVERTISEMENT AND PROMOTION OF PROBIOTICS IN THE USA
8. IMPORT REGULATIONS AND LOCAL AGENT REQUIREMENTS FOR THE MARKETING OF PROBIOTICS IN THE USA
9. CONCLUSION

Summary

• Regulatory oversight in the USA
• Information the strategy to launch probiotics
• Precise information on documents required, submission mode and timelines
• Regulations applicable on labelling requirements, claims and advertising
• Information on import regulations, requirement/qualification of a legal
• representative and post-marketing authorization