Inspections, Compliance, Enforcement, and Criminal Investigations

Atlantic Trading Co. LLC 7/8/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
College Park, MD 20740 

JUL 8, 2014

  
WARNING LETTER
 
 
VIA OVERNIGHT MAIL
 
Mr. Knut Skabo, President
Atlantic Trading Co., Inc.
1500 Weston Road
Weston, Florida 33326                                                    
Re: 422289
 
Dear Mr. Knut Skabo:
 
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)]. 
 
You can find the Act and FDA regulations through links in FDA’s home page at http://www.fda.gov.
 
Unapproved New Drug
 
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)].
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
 
  • “Omega-3s…lower triglycerides, reduce abnormal heart rhythms, reduce blood pressure…”
  • “Omega-3s have also shown promise in the prevention and treatment of certain cancers and inflammatory conditions, such as rheumatoid arthritis.”
  • “Diets including Omega-3 fatty acids have been shown to provide: Protection Against Heart Disease.”

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

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)].

Food Labeling Violations

Our review of your labeling revealed the following significant misbranding violations:

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.
 
The product label states the following:
 
  • “Fish high in Omega-3 reduce the risk of heart disease and lower blood pressure. The American Heart Association and U.S. Department of Health & Human Services recommends [sic] eating a 3-oz portion of fish high in Omega-3 at least twice a week.”
 
The website listed on your product label also bears the following claim:
 
  • “[P]acked with essential Omega-3 fatty acids and have [sic] been linked to lowering the risk of heart disease.”
 
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.
 
2.      Your Atlantic Salmon Boneless Skinless Center Cut Fillets product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears nutrient content claims, but the product does not meet the requirements to bear the claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. The following unauthorized nutrient content claims appear on your label:
 
  • “Atlantic Salmon boneless skinless fillets high in Omega-3 fatty acids”
  • “Naturally High Omega 3 Fatty Acids.”
 
The website listed on your product label also bears the following claim under the “Health & Wellness” section:
 
  • “Rich in Omega-3.”
 
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.  
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products or their labeling. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including but not limited to seizure and/or injunction. 
 
Within 15 days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation.  If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
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.
                       
 
Sincerely,
/S/
William A. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
      And Applied Nutrition
 
cc: FDA Florida District

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