What Is Pharmaceutical Grade Fish Oil?

Fish oil is a dietary supplement has been touted for its health benefits. Concerns over impurities, particularly mercury, in fish oil products have led fish oil producers to use "pharmaceutical grade" to describe their products. However, there is no standard definition of this term.

Misconceptions

• "Pharmaceutical grade" is a marketing term that fish oil companies use to convince consumers of the quality of their product. While the products they sell may indeed be high quality, the term "pharmaceutical grade" is not a reliable indication of this.

Certification

• According to Health Omega 3, no official standard that determines a fish oil's quality exists, and no organization conducts standardized tests to determine if a fish oil product is pharmaceutical grade. The U.S. Food and Drug Administration (FDA) is mum on fish oil products specifically, as fish oil is considered a dietary supplement. The FDA does not regulate dietary supplements and places the onus on the supplements' manufacturers for providing their customers with quality products.

FDA Approval

• In 2004, the FDA issued a qualified health claim for omega-3 fatty acids, which are most frequently found in fish oil. "These fatty acids are not essential to the diet; however, scientific evidence indicates that these fatty acids may be beneficial in reducing [coronary heart disease]," the claim said. Nowhere in the claim is the term "pharmaceutical grade" used. Since then, the FDA has officially approved one fish oil product, and it is only available through a prescription. This product does not bill itself as pharmaceutical grade.