| Public Health Service Food and Drug Administration |
Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
April 6, 2011
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 11-11
Robert Gaffney
President
Omega Nutrition U.S.A., Inc.
6515 Aldrich Road
Bellingham, WA 98226-9603
WARNING LETTER
Dear Mr. Gaffney:
The U.S. Food and Drug Administration (FDA) conducted an inspection on December 6-7, and 21, 2010, of your dietary supplement manufacturing facility, Omega Nutrition U.S.A., Inc., located at 6515 Aldrich Rd., Bellingham, Washington. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111. At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which delineated a number of violations that cause your dietary supplement products, EB Capsules, to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements. During our inspection, our investigators also collected labels for your EB Capsules and Flax Oil Capsules products. Based on our review of these labels, your EB Capsules and Flax Oil Capsules products are misbranded under section 403 of the Act [21 U.S.C. § 343].
Further, FDA reviewed your website at the Internet address www.omeganutrition.com in March 2011. Based on our review of your website, we have determined that the products 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 are promoted for uses that cause these products to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
You may find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov.
Significant violations include, but are not limited to, the following:
Dietary Supplement CGMP
You failed to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205(a). Specifically, you presented our investigators with a “Recipe Calculator Sheet” for (b)(4) capsules of EB Capsules as the master manufacturing record for that product. However, the document neither identified specifications for the manufacturing process, nor established controls and procedures to ensure that the specifications are met, as required by 21 CFR 111.205(b). Your master manufacturing record for each supplement and batch size must include the required elements listed in 21 CFR 111.210.
Misbranding
During our inspection, our investigators collected samples of labels associated with your EB Capsules and Flax Oil Capsules products. These products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to identify the products using the term “dietary supplement.” As required by 21 CFR 101.3(g), a dietary supplement must be identified by the term “dietary supplement” as part of the product’s statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product.
Unapproved New Drugs
Examples of some of the claims observed on your website www.omeganutrition.com include:
Hi-Lignan Nutri Flax Capsules
- “Lignans [a component of your product]… balance blood sugar and reduce cholesterol levels.”
- “[L]ignans have anti-bacterial, anti-viral and anti-fungal effects….”
Essential Balance Capsules
- “Omega-3 [an ingredient in your product] deficiency symptoms may include: … heart problems, … [and] depression….”
Hi-Lignan Flax Oil
- “[Lignans] … balance blood sugar and reduce cholesterol levels.”
- “Daily benefits of Omega Nutrition’s Lignan products: … Helps balance blood sugars and cholesterol levels … Promotes anti-bacterial, anti-viral and anti-fungal effects in the body ….”
Garlic-Chili Flax Oil
- “[G]arlic [an ingredient in your product] has been shown to have anti-bacterial, anti-viral, and anti-inflammatory properties. Chilies [an ingredient in your product] contain capsaicin, a compound that aids in the reduction of … heart disease, inflammation and ulcers.”
Borage Seed Oil
- “[Borage Seed Oil] is … a natural anti-inflammatory and is commonly used to ease stiffness and pain [from] arthritis….”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, each is a “new drug” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. The marketing of these products with these claims violates the Act. A new drug may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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.
The above violations are not meant to be an all-inclusive list of violations at your facility or deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm are in compliance with the Act and regulations enforced by FDA. You should take prompt action to correct the violations described above and prevent future recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, including, but not limited to, seizure and/or injunction.
In addition to the violations outlined above, we have the following comments:
- You must use safety-type shields or like materials over light bulbs when such devices are suspended over exposed components or dietary supplements in any step of preparation, unless your physical plant is otherwise constructed in a manner that will protect against contamination of components or dietary supplements in case of breakage of glass or glass-like materials as required by 21 CFR 111.20(f). However, unshielded fluorescent light bulbs were observed above the pumpkin seed powder staged in the powder filling room and directly above the filling and packaging lines in the liquid filling room.
- You failed to adequately install and maintain a plumbing system that prevents backflow from, or cross connection between, piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities as required by 21 CFR 111.15(f)(5). Specifically, no backflow prevention devices were observed on hose bibs in the tote washing area and two outside hose bibs leading to the cold storage out building.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should detail the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. You should include in your response any documentation necessary to demonstrate that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for your delay and the time frame within which any remaining violations will be completed.
Please send your reply and any supporting documents to the attention of Peter C. Chow, Compliance Officer at the following address:
U.S. Food and Drug Administration
Seattle District Office
22201 23rd Drive SE,
Bothell, Washington 98021-4421.
If you have any questions about the content of this letter, please contact Mr. Chow at 425-483-4766 or via email at peter.chow@fda.hhs.gov.
Sincerely,
/S/
Charles M. Breen
District Director
cc:
Philip C. Fraley
Operations Manager
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