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U.S. Department of Health and Human Services

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Enforcement Actions

Woodward Laboratories 25-Oct-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, CA 92612-2506
Telephone (949) 608-2900



WARNING LETTER

W/L 02-06

CERTIFIED MAIL
RECEIPT REQUESTED

October 25, 2005

Kenneth B. Gerenraich
Chief Executive Officer
Woodward Laboratories
125-B Columbia
Aliso Viejo, CA 92656-1458

Dear Mr. Gerenraich:

During an inspection of your facility located at 125-B Columbia, Aliso Viejo, California, conducted July 29-August 11, 2004, our investigator collected labeling for some of the over-the-counter (OTC) products distributed by your firm. Review of this material along with information currently appearing on your internet web site www.woodwardlabs.com, indicates that your product, MYCOCIDE NAIL SOLUTION NS (MYCOCIDE NS), is a drug as defined in 21 U.S.C. 321(g) and a new drug as defined in 21 U.S.C. 321(p) that is not the subject of an approved New Drug Application (NDA). Therefore, the product is being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The brand name "MYCOCIDE" suggests and represents that the intended use of this brand of products is to full fungi (see, for example, Webster's Third New International Dictionary of the English Language). In addition, the product label for MYCOCIDE NS contains statements such as "Antimicrobial," "Treatment of microbial infection affecting fingers and toe areas, skin around the nails, and under the free edge," and "Application to adjacent and toes is recommended to prevent the spread of infection." Because the label and other labeling include statements that represent and suggest that this product, MYCOCIDE NS, is intended to be used in the diagnosis, cure, mitigation, treatment or prevention of disease, or that it is intended to affect the structure or any function of the body of man, this product is a drug within the meaning of Sections 201(g)(B) and (C) of the ,Act [21 U.S.C. 321(g)(B) and (C)].

The product label (the immediate product container) of MYCOCIDE NS, under the Drug Facts, Other information section, bears a statement, "This product is not effective on scalp or nails ." Notwithstanding this disclaimer, the name "MYCOCIDE NAIL SOLUTION NS" represents and suggests that the product is useful in killing fungi of the nails. In addition, your firm's web site, www.woodwardlabs.com, contains statements, that serve as evidence of the product's intended use for treating nails, such as, "The Complete Solution for Problem Nails . . . about infections of nail and nail areas . . . Broad spectrum formula kills fungus . . . that cause infections . . . Up to 50% of nail s problems are caused by bacteria as well as fungus . . . penetrates to the site of infection . . . 50% of people over age 60 have at least one infected nail . . . Patented formulation penetrates to the site of infections . . . effectively kills the fungus . . . that cause infections making fingers, toes, and the areas around and under nails look and feel better . . . ." Such evidence represents and suggests that the product is useful as an antifungal, particularly for use in treating fungal conditions of the nails and surrounding areas.

Based on the claims and representations made in the product labeling and evidence of the product's intended use, MYCOCIDE NS is subject to final regulations covering topical antifungal OTC drug products [Title 21, Code of Federal Regulations (CFR), Part 333, Subpart C] and drug products containing certain active ingredients offered OTC for use on nails [21 CFR 310.545(a)(22)(iii)]. However, the active ingredient for this product, benzalkonium chloride, is not approved for treating fungal conditions under this topical antifungal monograph. Therefore, your product is a "new drug" that may not be legally marketed in the United States without an NDA [Section 505(a) of the Act (21 U.S.C. 355(a))].

Moreover, under the final regulation for the drug products containing certain active ingredients offered OTC as a topical antifungal drug product, any OTC drug product that is labeled with claims or directions for use on the nails or scalp is not considered generally recognized as safe and effective and is therefore regarded as a new drug [Section 201(p) of the Act (21 U.S .C. 321(p)]. This is additional support that MYCOCIDE NS is a "new drug" that may not be legally marketed in the United States without an approved NDA [21 U.S .C. 355(a)].

Further, despite product labeling attempting to describe MYCOCIDE NS as an antimicrobial, it is not being legally marketed pursuant to the applicable tentative final monograph [59 FR 31402 (1994)]. MYCOCIDE NS is not acceptable as an antimicrobial drug product in that we are unaware that the ingredient, benzalkonium chloride, was ever used as an active ingredient in OTC antimicrobial drug preparation in the United States for the above mentioned indications on or before December 4, 1975. Therefore, MYCOCIDE NS is not eligible for inclusion in the OTC Drug Review for OTC Antimicrobial Drug Products.

In addition, MYCOCIDE NS is misbranded within the meaning of Section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in that its labeling does not contain adequate directions for use as this term is defined in 21 CFR 201.5. Because the conditions for which it is Letter to Mr. Gerenraich offered are not amenable to self diagnosis and treatment by the laity, adequate directions for use cannot be written under which laymen can use this drug safely and for the use for which it is intended. This product is also misbranded within the meaning of Section 502(a) of the Act [21 U.S.C. 352(a)] in that both the disclaimer and the name of the product on the label is misleading as described above.

This letter does not represent a comprehensive review of all the products your firm distributes. It is your responsibility to assure that your firm's operations and controls adhere to all applicable regulations.

These violations may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure and/or injunctions. In addition, federal agencies are advised of the issuance of all Warning Letters so that they may consider this information when awarding government contracts.

Please notify this office in writing within fifteen working days from the date that you receive this letter of the actions that you are taking to correct and prevent the recurrence of the violations outlined above. Your response should include the specific timeframes necessary to take these steps. If you have any questions concerning this letter, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.

Your reply should be sent to:

Pamela B. Schweikert
Director, Compliance Branch
U.S . Food & Drug Administration
19701 Fairchild
Irvine, CA 92612

Sincerely,

/S/

Alonia E. Cruse
District Director