Fda Dietary Supplement Expiration Date

Most of what is known about drug expiration dates comes from a military requested study conducted by the food and drug administration fda.
Fda dietary supplement expiration date. Passed in 1979 u s. Law requires drug manufacturers to stamp an expiration date on their products. If expiration dates or voluntary claims such as best by or use before appear on a nutritional supplement label fda officials expect supporting stability test data to be available.
These questions are a consequence of the activity in this area over the past several years. The food and drug administration fda the agency that oversees the manufacture and labeling of dietary supplements does not require an expiration date on dietary supplements but requires that if one is used it must be supported by stability testing data. Five statements are required.
The food and drug administration fda receives many questions about the labeling of dietary supplements. Adverse effects with dietary supplements should be reported to fda as soon as possible. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.
By andy swenson april 15 2015. Fda s guidance for industry changes to an approved nda or anda explains that the manufacturer of an approved drug product may extend the expiration date for the drug product based on. Expiration dates on vitamins and dietary supplements are extremely conservative to ensure consumers receive quality products.
The dietary supplement ds cgmp rule in 21 cfr part 111 the ds cgmp rule requires persons who manufacture package label or hold a dietary supplement to establish and follow current. 1 the statement of identity name of the dietary supplement 2 the net quantity of contents statement amount of the dietary supplement 3 the nutrition labeling.