Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs...
-
Upload
annis-franklin -
Category
Documents
-
view
217 -
download
3
Transcript of Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs...
![Page 1: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/1.jpg)
Dietary Supplements
Bradford W. WilliamsSpecial Assistant
Division of Dietary Supplement Programs
ONPLDS, CFSAN, FDA
![Page 2: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/2.jpg)
Laws Regulating Dietary Supplements
Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Food, Drug, and Cosmetic Act (FD&C Act)Defined the term dietary supplement
Included dietary supplements under the FD&C Act’s adulteration provisions
Established requirements for new dietary ingredients
![Page 3: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/3.jpg)
Definition of Dietary Supplement
Product (other than tobacco) that is intended to supplement the diet
Contains one or more of the following dietary ingredients:VitaminMineralHerb or other botanicalAmino acid
![Page 4: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/4.jpg)
Definition of Dietary Supplement
Dietary ingredients (continued):Other dietary substance used by man to
supplement the diet by increasing total dietary intake (e.g., glandulars, organ tissues & enzymes)
A concentrate, metabolite, constitute, extract, or combination of any of the above dietary ingredients
![Page 5: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/5.jpg)
Dietary Supplement Forms
Tablet Capsule Liquid Powder Softgel Gelcap
![Page 6: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/6.jpg)
Other Requirements for Dietary Supplements
Cannot be represented as a:Conventional foodSole item of a meal
Must be intended for ingestion
Must be labeled as a dietary supplement
![Page 7: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/7.jpg)
Excluded As Dietary Supplements
Articles approved or authorized for investigation as a new drug, antibiotic, or biologic that were not first marketed as a dietary supplement or as a food
![Page 8: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/8.jpg)
Structure-Function Claims 21 CFR 101.93
May make claims about:Nutritional deficiency diseaseStructure/functionMechanism of effect on structure/functionGeneral Well Being
![Page 9: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/9.jpg)
Requirements to make claims
Must be an allowed claim Must have substantiation it is truthful
and not misleading May not claim to treat/cure/prevent
disease Must use mandatory disclaimer Must notify FDA
![Page 10: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/10.jpg)
NOTIFICATION REQUIREMENTS:Ingredients: New Dietary Ingredients (NDIs)
NDI: Those ingredients that were not marketed in the U.S. prior to October 15, 1994
Note : There is no authoritative list of dietary ingredients that were marketed before October 15, 1994
![Page 11: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/11.jpg)
NDI Premarket Notifications
Manufacturers or distributors must submit a notification to FDA 75 days before a new dietary ingredient is marketed or introduced for marketing in the U.S.
This notification must meet the requirements of 21 CFR § 190.6.
(http://www.cfsan.fda.gov/~lrd/cfr190-6.html)
![Page 12: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/12.jpg)
NDI Premarket Notifications
Safety standard is history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling, is reasonably expected to be safe.
Notification must set forth manufacturer’s basis upon which they have concluded they have met standard.
![Page 13: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/13.jpg)
NDI Notification Process
For 75 days after the “filing” date, the manufacturer or distributor is not permitted to introduce or deliver for introduction into interstate commerce the dietary supplement(s) containing the NDI.
![Page 14: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/14.jpg)
NDI Notification Process
For 90 days after the “filing” date, FDA will not disclose the existence of, or information contained in, the NDI notification.
Afterwards, the NDI notification will be placed on public display at FDA’s Documents Management Branch in Docket number 95S-0316.
![Page 15: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/15.jpg)
NDI Notification Process
New dietary ingredients reviewed by FDA are not “approved” or “authorized” by FDA.
If a manufacturer or distributor does not hear from FDA by 75 days after the “filing” date of its notification, it may legally market in the U.S.
![Page 16: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/16.jpg)
Safety Responsibilities
The manufacturer of a dietary supplement is responsible for ensuring that it is safe before it is marketed in the U.S.
FDA is responsible for taking action against any unsafe dietary supplements after they are marketed in the U.S.
![Page 17: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/17.jpg)
Adulteration of Dietary Supplements
A dietary supplement is adulterated if it: Poses a significant or unreasonable risk of illness
or injury when it is used as directed on the label
Poses an imminent hazard to public health or safety
Contains a poisonous or harmful substance
Contains an NDI unless:
• There is history of use as a food in the U.S. in a form not chemically altered, or
• There is evidence of safety and the NDI has been reviewed by FDA through the 75-day premarket notification process
![Page 18: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/18.jpg)
Product quality:
At present, the manufacturer is responsible for establishing its own guidelines to ensure that the dietary supplements and dietary ingredients it produces are safe and contain the ingredients declared on the label.
![Page 19: Dietary Supplements Bradford W. Williams Special Assistant Division of Dietary Supplement Programs ONPLDS, CFSAN, FDA.](https://reader036.fdocuments.in/reader036/viewer/2022082710/56649dd95503460f94ace9d7/html5/thumbnails/19.jpg)
CONTACTS for dietary supplement information
www.cfsan.fda.govClick dietary supplements in middle of page
General QuestionsBradford Williams (301)436-1440
Notificationsnew dietary ingredients(75 DAY): Ms. Victoria
Lutwak 301-436-2375Claims(30 day): Dr. Robert Moore, 301-436-2375