FDA WARNING_LETTER - Premium Gold Flax Products & Processing Inc.

The FDA issued a Warning Letter to Premium Gold Flax Products & Processing, Inc. following a May 2011 review of their websites, www.premiumgoldflax.com and www.FlaxHullLignan.com. The agency determined that the firm's flaxseed products were promoted with therapeutic claims, such as protecting against cancer, diabetes, reducing inflammation, lowering cholesterol, and treating breast cancer. These claims cause the products to be classified as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. As the products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) and require prior FDA approval under section 505(a) before legal marketing. Furthermore, due to the nature of the conditions treated, adequate directions for use cannot be provided for a layperson, rendering the products misbranded under section 502(f)(1). The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act. The FDA requires prompt corrective action and a written response within 15 working days detailing steps taken to address these violations and prevent recurrence. Failure to comply may lead to enforcement actions, including product seizure and injunctions.