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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Cohen, Richard M.D. 09-Feb-05

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
60 Eighth Street, N.E.
Atlanta, GA 30309

Telephone 404-253-1191
FAX: 404-253-1202


 

February 9, 2005

VIA FEDEX

WARNING LETTER
(05-ATL-07)

Dr. Richard Cohen
1060 Columbine Road
Asheville, NC 28803

Dear Dr. Cohen:

This letter concerns your fIrm's marketing of the product "OcuZyme" (1% N-Acetyl Carnosine) on your website, www.ocuzyme.com. OcuZyme is sold as "a non prescription, anti-oxidant eye solution" and as "Lubricant eye drops with a unique anti-oxidant." According to product labeling on your website, OcuZyme is intended to prevent, treat, or cure serious disease conditions. Statements documenting these intended uses include the following:

"The use of OcuZyme may be particularly important for anyone who:

  • is 35 years old or older
  • is nearsighted
  • wears reading glasses
  • is .African American
  • has a family history of cataract and/or glaucoma
  • has had excessive exposure to sunlight
  • has a history of internal eye injury or bleeding
  • has had previous eye surgery" has used oral and/or ocular steroid medication (including eye drops)
    for a prolonged period of time
  • has high blood pressure
  • has poor circulation
  • has diabetes
  • has experienced chronic or recurring inflammation within the eye"
  • has been diagnosed with "cupping" of the optic nerve"
  • "OcuZyrne Protects the Eye Against Cataracts.
  • "OcuZyme Protects the Human Eye Against Aging."
  • "For enhanced vision related to cataracts, glaucoma or other eye illnesses: . . . "

OcuZyme 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, OcuZyme 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 intended 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. OcuZyme 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, OcuZyme is subject to the final rule under Title 21, Code of Federal Regulations, Part 349 (21 CFR Part 349) concerning OTC ophthalmic drug products . The final rule does not provide for inclusion of the claims cited, nor for the ingredient n-acetyl carnosine, listed on your website. Consequently, OcuZyme, as it is currently promoted on your website, 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.

Furthermore, many of the conditions for which this product is offered, for example, cataracts, glaucoma, diabetes, and high blood pressure, 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, we are prepared to take 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 cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Address your reply to the U.S. Food and Dug Administration, 64 Eight Street, NE, Atlanta, GA 30309 Attention: James MacLaughlin,
Compliance Officer.

Sincerely,

/S/

Mary H. Woleske
Director, Atlanta District

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