FDA Follows 483 to Omega Nutrition with Warning Letter

BELLINGHAM, Wash.—Omega Nutrition U.S.A. received an FDA warning letter in early April, which reiterated concerns cited during a December 2010 GMP (good manufacturing practice) inspection and 483 report, as well as product claims used on labels and in marketing.

FDA inspectors visited Omega Nutrition’s manufacturing facility in Bellingham, Wash., in early December 2010, and issued a 483 form listing several violations of GMP regulations that cause products under production to be adulterated. In particular, the agency noted the company failed to prepare and follow a written master manufacturing record for each unique formulation of a product, and for each batch size. While there was a “recipe calculator sheet" used, it did not identify specifications for the manufacturing process, nor established controls and procedures to ensure specs were met.

In relation to product claims, during the December visit, FDA inspectors collected labels for the company’s EB Capsules and Flax Oil Capsules, and determined the items are misbranded as the labels do not use the term “dietary supplement" as the statement of identity. The agency also reviewed the company’s website in March 2011, and stated several products are promoted using therapeutic claims that position the products as unapproved new drugs, not dietary supplements. Cited claims related to particular ingredients such as lignans (“anti-bacterial, anti-viral and anti-fungal effects" and “balance blood sugars and cholesterol levels"), omega-3 (“deficiency symptoms may include … heart problems [and] depression") and chilies (“contain capsaicin, a compound that aids in the reduction of … heart disease, inflammation and ulcers"). Among the named products were Hi-Lignan Nutri-Flax Capsules, Essential Balance Capsules, Omega Plus Flax-Borage Oil Capsules, Hi-Lignan Flax Oil, Garlic-Chili Flax Oil and Borage Seed Oil.