FDA GMP violation (Omega Nutrition)

[Guest guest]

Omega Nutrition U.S.A., Inc. 4/6/11

Department of Health and Human Services

Public Health Service

Food and Drug Administration

Seattle District

Pacific Region

22201 23rd Drive SE

Bothell, WA 98021-4421

Telephone:

FAX:

April 6, 2011

VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 11-11

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)( of the Act

[21 U.S.C. § 321(g)(1)(]. 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

athttp://www.fda.gov

<http://www.mynewsletterbuilder.com/tools/refer.php?s=3056052287 & u=23356785 & v=3 & \

key=5c88 & skey=22afeecfe6 & url=http%3A%2F%2Fwww.fda.gov%2F> .

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 ((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(. 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)( of the Act [21 U.S.C. §

343(s)(2)(] 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 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 or via email at peter.chow@....

Sincerely,

/S/

M. Breen

District Director

cc:

Philip C. Fraley

Operations Manager

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive

Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com