As published by the FDA
“In response to requests from the public, the FDA has extended the comment period for the revised draft guidance to improve dietary supplement companies’ new dietary ingredient premarket safety notifications to the agency.
The comment period will now end on Dec. 12, 2016. Due to the complexity of this issue, the FDA is committed to providing the public with more time to submit comments.
The FDA will thoroughly review all public comments and information submitted before determining its next steps”.
To read more about the proposed “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry”, please visit:http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf
U.S. Department of Health and Human Services Food and Drug Administration. Center for Food Safety and Applied Nutrition.
Consultation on the regulation of self-care products
The purpose of this consultation is to ask for comments on our proposed approach to regulating self-care products.
- Health Canada is proposing a new structure for classifying self-care products that would be based on a product’s risk. In this case, the risk level of the product is determined by the safety of the product.
- Under the proposed Framework, as a consumer, you would continue to have access to a wide range of self-care products.
- Health Canada would not be reviewing and approving products in the lowest risk group, and this would be a significant change for some products.
- Health Canada does not seek to limit or restrict access to products that pose minimal risk to Canadians. Rather, HC are seeking ways to continue to provide consumers with access to a wide range of choices of self-care products and make the necessary information available to support informed decision-making.
- For higher-risk products, Health Canada would review and approve all products before they could legally be sold in Canada.
To read more on “Consulting Canadians on the Regulation of Self-Care Products in Canada”, please visit: