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U.S. Department of Health and Human Services

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Enforcement Actions

Nucura Pharmaceuticals, Inc. 18-May-05

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone ( 949) 608-2900


WARNING LETTER

VIA FEDEX

May 18, 2005

WL: 15-05

Mr. Christopher Clark, CEO
Ms. Rebecca Chapman, President
Nucura Pharmaceuticals, Inc.
6409 Caminito Blythefield
La Jolla, CA 92037-5804

Dear Mr. Clark and Ms. Chapman:

This letter concerns your firm's marketing of the product "NU-EYESTM" on your website, www.bionational .com. NU-EYES is sold as non-prescription "Lubricant Eye Drops with unique anti-oxidant N-Acetyl Carniosine." According to product labeling, NU-EYES is intended to prevent, treat, or cure serious disease conditions. Statements documenting these intended uses include, but are not limited to, the following:

• "NU-EYESTM has been proven in Russian clinical trials to reduce the occurrence and slow the development of senile cataract."
•"NU-EYESTM can be used to treat corneal disorders "
•"NU-EYESTM can end the discomfort of ocular inflammation."
• "NU-EYESTM has been used with great success in the fight against retinal diseases."
•"NU-EYESTM has been used in the treatment of vitreous opacities and lesions."
• "Nu-EyesTM - with N-acetylcarnosine Patented by Innovative Vision Products. Proven anti-oxidant properties reduce and protect the crystalline-lens from oxidative stress-induced, cross-linking damage which often result [sic] in ocular inflammation, primary open angle glaucoma, and retinal disorders."
"Nu Eyes - relief for dry eyes, relief for computer eve strain, blurred vision medication, computer eye strain remedy, treatment of cataract symptoms, helps avoid cataract surgery contact lens irritations computer vision syndrome, treatment of contact lens disorders,'senile cataract."

NU-EYES is a drug, as defined by the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 321(g), because it is intended to cure, mitigate, treat, or prevent disease. Moreover, NU-EYES is a new drug as defined by 21 U.S.C. § 321(p), because there is no evidence that it is generally recognized as safe and effective for its labeled uses. Under 21 U.S.C. § 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. NU-EYES does not have an approved application and its introduction and delivery into interstate commerce violates 21 U.S.C. § 331(d).

Also, based on its intended uses, NU-EYES is subject to the final rule under Title 21 Code of Federal Regulations, Part 349, concerning over-the-counter (OTC) ophthalmic drug products. The final rule does not permit the claims cited on your website, nor the ingredient n-acetyl carnosine. Consequently, NU-EYES fails to meet the requirements of the final OTC rule, causing it to be a new drug that requires an FDA-approved application for marketing.

Additionally, you make false and misleading promotional statements on your website. For example, your website states, "(a]pproved by the FDA for ophthalmic use, Nu-Eyes lubricants . .. . " NU-EYES is not the subject of an FDA-approved application, and this statement causes your product to be misbranded under 21 U.S.C. § 352(a).

Furthermore, many of the conditions for which this product is offered, for example, cataracts, corneal disorders, ocular inflammation, retinal diseases, and glaucoma, are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for these conditions cannot be written so that a layman can use this drug safely for its intended purposes . Because your product's labeling fails to bear adequate directions for its intended uses, it is misbranded under 21 U.S.C. § 352(f)(1).

The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to an enforcement action against you without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturers and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations, and the steps taken to assure that similar violations will not recur. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Further, if your firm does not manufacture the product, your reply should also include the name and address of the manufacturer: If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturing firm. If you have any questions regarding this warning letter, please contact Scott Goff at 949-608-4433.

Please direct your written response to the attention of:

Pamela B. Schweikert
Director, Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

Sincerely,

/S/

Alonza E. Cruse
Director, Los Angeles District

cc: Nucura Pharmaceuticals, Inc.
President, Rebecca Chapman
CEO, Christopher Clark.
101 Convention Center Dr.
Suite 700
Las Vegas, NV 89109

Nucura Pharmaceuticals, Inc.
President, Rebecca Chapman
CEO, Christopher Clark
P.O. Box 27740
Las Vegas, NV 89126

President or CEO
BioNational Pharmaceuticals, Inc.
Attention: Consumer Affairs
101 Convention Center Dr., Ste. 700
Las Vegas, NV 89109

President or CEO
Innovative Vision Products, Inc.
Delaware Registry, Ltd.
3511 Silverside Road, Suite 105
Wilmington, DE 19810