Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm408707.htm
Timestamp: 2019-04-22 10:03:30+00:00

Document:
The Food and Drug Administration (FDA) has reviewed the label for the Atlantic Salmon Boneless Skinless Center Cut Fillets product distributed by your firm. The label for that product directs the consumer to your website at the Internet address www.cwirthy.com via the statement, “for more ocean-farmed salmon facts, great recipes and tips visit www.cwirthy.com[.]” We examined the product label in January 2014 and website in June 2014. The website promotes your Atlantic Salmon Boneless Skinless Center Cut Fillets product for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on the website establish that the product is a drug because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
Even if your Atlantic Salmon Boneless Skinless Center Cut Fillets product was not an unapproved new drug, it would still be a misbranded food within the meaning of section 403 of the Act [21 USC § 343] because the labeling bears unauthorized health claims in violation of 403(r)(1)(B) of the Act [21 USC § 343(r)(1)(B)] and unauthorized nutrient content claims in violation of 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)]. The introduction of a misbranded food into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
As stated above, we reviewed your website at the Internet address www.cwirthy.com in June 2014 and determined that your product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)].
Furthermore, your Atlantic Salmon Boneless Skinless Center Cut Fillets product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended use. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. §352(f)(1)], in that its labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
1. Your Atlantic Salmon Boneless Skinless Center Cut Fillets product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 USC § 343(r)(1)(B)] because the labeling bears unauthorized health claims.
These claims cause your products to be misbranded under section 403(r)(1)(B) of the Act because they are health claims that have not been authorized by regulation or the Act.
Under section 403(r)(l)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim. FDA has issued a regulation specifying criteria for the use of the nutrient content claim “high” in food labeling, which also applies to the synonymous claim “rich in” (see 21 CFR 101.54(b)(1)). This regulation requires a food that bears these claims to contain 20 percent or more of the Daily Value (DV) of the nutrient per reference amount customarily consumed. However, this regulation does not authorize your claims because there is no DV for omega-3 fatty acids. Therefore, the use of the terms “high,” “naturally high,” and “rich in” to characterize the level of omega-3 fatty acids misbrands your product under section 403(r)(1)(A) of the Act.
We note that there are alternative ways to convey the amount of Omega-3 fatty acid in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA toauthorize a new nutrient content claim for Omega-3 fatty acids (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.
You should direct your written reply to Carrie Lawlor, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions regarding this letter, please contact Ms. Lawlor via e-mail at carrie.lawlor@fda.hhs.gov.

References: § 321
 § 343
 § 343
 § 343
 § 331
 §352
 § 331
 § 343