Dietary Supplement Stability Testing Fda

An observation commonly noted in fda warning letters to dietary supplement companies is the use of a shelf life date with an assumed lack of data which supports that date.

Dietary supplement stability testing fda. The food and drug administration fda receives many questions about the labeling of dietary supplements. Within the past. Laboratory testing services dietary supplements analysis.

Although the value they receive depends on the amount of active ingredient present in the product most regulatory environments don t require stability studies on the main ingredients. Based on new dietary supplement gmps dietary supplement analysis ensures that each product meets strict restrictions based on efficacy and safety. Consumers increasingly demand food supplements with high quality safety and efficacy.

A dietary supplement is a product taken by mouth that contains a dietary ingredient intended to supplement the diet the fda adds that the dietary ingredients inside supplements can include vitamins minerals herbs or other botanicals amino acids and substances such as enzymes organ tissues glandulars and. Dietary supplements fda page 4 9. However when reviewing the part 111 final rule and other statements made by the fda a conflict quickly arises.

Read pdf stability testing of dietary supplements nsf international state of the art supplement and functional food. Dietary supplement and use the results of the stability testing to determine the appropriate storage conditions and expiration dates. The consumption of dietary supplements continue to rise within the united states and in 2013 americans spent approximately 34 9 billion on supplements.

These questions are a consequence of the activity in this area over the past several years. Nsf international has helped create a new voluntary stability testing guideline for supplement manufacturers to ensure they have the necessary data to support expiration dating on product labels. Stability testing of dietary supplements with this confusing regulatory requirements backdrop the challenges for stability testing of.

To contact the office of dietary supplement programs email. At first glance this appears to be a legitimate requirement. Food and drug administration cgmp standards require stringent inspection of dietary ingredients and nutritional supplements in order to prevent inaccurate labeling adulteration or contamination with pesticides heavy metals or toxic botanicals.