Does the FDA Endorse ASTM Standards?

The FDA is a U.S. government agency responsible for ensuring the safety of all food and drug products available in the U.S. The ASTM is a private organization that coordinates with business and customers worldwide to develop voluntary consensus standards. While the FDA does regard ASTM very highly, it does not necessarily endorse all of their standards.

FDA and ASTM

• FDA stands for the Food and Drug Administration, which is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for assuring the safety of all drugs and food products commercially available in the United States. ASTM stands for the American Society for Testing and Materials. ASTM International is a private organization that develops and delivers international voluntary consensus standards for a wide variety of products, including food and drugs.

Endorsement

• According to Don Marlowe, standards administrator at FDA, "ASTM is a major source of the standards FDA uses in the management of risk for products and test methods." This suggests that while the FDA does not necessarily endorse all of the ASTM's standards, they are a very reliable resource for the FDA and the FDA takes their recommendations very seriously.

Standard Setting Process

• It should be noted that the FDA may endorse the ASTM standard-setting process for a certain kind of product. However, as noted above, this does not necessarily mean that the FDA endorses all the standards recommended by the ASTM using that process.