The U.S. Food and Drug Administration (FDA) conducted an inspection on December 6-7, and 21, 2010, in the 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, the company was issued a Form FDA 483, List of Inspectional Observations, which delineated a number of violations that cause the 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 the inspection, investigators also collected labels for the EB Capsules and Flax Oil Capsules products. Based on the review of these labels, the EB Capsules and Flax Oil Capsules products are misbranded under section 403 of the Act [21 U.S.C. § 343].
Further, FDA reviewed the company’s website at the Internet address www.omeganutrition.com in March 2011. Based on the review of the website, the FDA 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 the website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease.
Significant violations include, but are not limited to, the following:
Dietary Supplement CGMP
The company, Omega Nutrition U.S.A., Inc., failed to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that the manufacture and for each batch size, as required by 21 CFR 111.205(a). Specifically, the company presented the 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). The master manufacturing record for each supplement and batch size must include the required elements listed in 21 CFR 111.210.
During FDA’s inspection, the investigators collected samples of labels associated with the 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 the website www.omeganutrition.com include:
Hi-Lignan Nutri Flax Capsules
- “Lignans [a component of the 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 the 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 the product] has been shown to have anti-bacterial, anti-viral, and anti-inflammatory properties. Chilies [an ingredient in the 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….”
The 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 the facility or deficiencies in the products and their labeling. It is the company’s responsibility to ensure that products marketed by the firm are in compliance with the Act and regulations enforced by FDA. Omega Nutrition 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, FDA have the following comments:
· Omega Nutrition 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 the 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.
· Omega Nutrition 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.