ADVERSE EVENT REPORTS
References and other helpful links
Supplement Adverse Event Reports Grow, But FDA Says 'Serious' Intel Is Short
Supplement Adverse Event Reports Grow, But FDA Says 'Serious' Intel Is Short
BOTANICAL ADULTERATION PREVENTION PROGRAM
Free FSPC Intentional Adulteration Course
To take the course, use on the link: https://www.ifsh.iit.edu/fspca/courses/intentional-adulteration and then click on the “Launch the Course” button.
For more information click here.
References and other helpful links
American Botanical Council, American Herbal Pharmacopoeia and National Center for Natural Products Research: Botanical Adulteration Prevention Program: http://cms.herbalgram.org/BAP/index.html
American Botanical Council Herbal Library: http://abc.herbalgram.org/site/PageServer?pagename=Herbal_Library
To take the course, use on the link: https://www.ifsh.iit.edu/fspca/courses/intentional-adulteration and then click on the “Launch the Course” button.
For more information click here.
References and other helpful links
American Botanical Council, American Herbal Pharmacopoeia and National Center for Natural Products Research: Botanical Adulteration Prevention Program: http://cms.herbalgram.org/BAP/index.html
American Botanical Council Herbal Library: http://abc.herbalgram.org/site/PageServer?pagename=Herbal_Library
BOTANICAL MONOGRAPHS
LABELING/CLAIMS
References and other helpful links
Compliance Program: Dietary Supplements-Import and Domestic (Implementation Date: 03/26/2010) includes Pen & Ink Changes as of 07/08/10 to Parts I and II
http://www.fda.gov/food/complianceenforcement/foodcomplianceprograms/ucm071547.htm
An example FDA Form 482 – Notice of Inspection
file:///C:/Users/laris/AppData/Local/Microsoft/Windows/INetCache/IE/1Q61LCKA/5-1_FORM_FDA_482_NOTICE_OF_INSPECTION[1].pdf
Investigations Operations Manual Chapter 5: Establishment Inspections
http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Key Inspectional References
21 Code of Federal Regulations Part 111
PART 111—CURRENT GOOD MANUFACTURING PRACTICE (GMP) IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111&shoF1
21 CFR Part 110: Food GMPs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=110
Biennial Food Facility Registration Renewal (October 1-December 31, 2014)
https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm324780.htm
Food links including labeling
http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
A Food Labeling Guide, Guidance for Industry
https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf
Allergens
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
The FSMA Technical Assistance Network (TAN) is now operational and providing technical assistance to industry, regulators, academia, consumers and others regarding FSMA implementation. The website is found at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
Compliance Program: Dietary Supplements-Import and Domestic (Implementation Date: 03/26/2010) includes Pen & Ink Changes as of 07/08/10 to Parts I and II
http://www.fda.gov/food/complianceenforcement/foodcomplianceprograms/ucm071547.htm
An example FDA Form 482 – Notice of Inspection
file:///C:/Users/laris/AppData/Local/Microsoft/Windows/INetCache/IE/1Q61LCKA/5-1_FORM_FDA_482_NOTICE_OF_INSPECTION[1].pdf
Investigations Operations Manual Chapter 5: Establishment Inspections
http://www.fda.gov/ICECI/Inspections/IOM/default.htm
Key Inspectional References
21 Code of Federal Regulations Part 111
PART 111—CURRENT GOOD MANUFACTURING PRACTICE (GMP) IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111&shoF1
21 CFR Part 110: Food GMPs
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=110
Biennial Food Facility Registration Renewal (October 1-December 31, 2014)
https://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm324780.htm
Food links including labeling
http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
A Food Labeling Guide, Guidance for Industry
https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM265446.pdf
Allergens
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
The FSMA Technical Assistance Network (TAN) is now operational and providing technical assistance to industry, regulators, academia, consumers and others regarding FSMA implementation. The website is found at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
SUPPLEMENT REGISTRY
The Supplement OWL (Online Wellness Library): Dietary supplement companies are encouraged to upload their product labels. This self-regulatory initiative will help create a more complete picture of the marketplace. https://www.crnusa.org/newsroom/supplement-owl-takes-flight-dietary-supplement-product-registry-now-live
ONLINE EDUCATION & COURSES
NEW FSPCA Course Announcement! FSPCA Overview of the Intentional Adulteration Rule (IA Rule) Course. Who should take the course? While this training course is optional and not required for compliance with the IA Rule, the information within this training will assist food facilities that are required to comply with the IA Rule, and other stake holders, to have a more in-depth understanding of the requirements in the IA Rule. https://lms.ifpti.org/#/courses/course/af9abd10-e306-4b00-9ed9-30353a8524f0
