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U.S. Department of Health and Human Services

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E.I. DuPont DeNemours and Company 07-May-07

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

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390


CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
07-PHI-04

May 7, 2007

Charles O. Holliday, Chairman and CEO
E.I. duPont de Nemours and Company
1700 Market Street
Wilmington, DE 19802-4809

Dear Mr. Holliday:

This letter concerns your firm's labeling and marketing of the products "DuPont RelyOn Antiseptic Spray" and "DuPontRelyOn Antiseptic Hand Wipes." As presently labeled and promoted, these products violate the new drug and misbranding provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described in detail below.

According to the package labeling and your Internet websites (www.relyon.dupont.com and www2.dupont.com), these products are intended for topical antimicrobial use to prevent various diseases. Statements on the respective package labeling that demonstrate these intended uses include the following:

"Based on in vitro testing, DuPont RelyOn Antiseptic [Spray and Hand Wipes are] 99% effective in killing Hepatitis A, B, and C, HIV-1 (AIDS virus), methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), Herpes simplex-Type 2, Escherichia coli (E.Coli strain 0157), Mycobacterium bovis (BCG, TB surrogate)... Salmonella choleraesuis, Respiratory syncytial virus. (RSV), Rotavirus (SA-1 I-Group A), Influenza type A-2 virus (Hong Kong), Tri cophyton mentagrophytes (Athletes foot fungus), Cytomegalovirus (CMV), and Adenovirus-Type2."

In addition, the front panel of the labeling for the "DuPont RelyOn Antiseptic Spray" product includes the statement: "Effective against Hepatitis A, B, and C based on in vitro efficacy testing." The front panel of the labeling for the "DuPont RelyOn Antiseptic Hand Wipes" product includes the statement: "Also effective against Hepatitis A, B, and C! based on in vitro efficacy testing."

Similar claims appear on the Internet websites referenced above, along with statements
that demonstrate additional topical antimicrobial uses to prevent disease, such as:

"help[s] slow the spread of infectious agents such as SARS . . ."

"DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" are "drugs," as defined by section 201(g)(1) of the Act (21 U.S.C. § 321(g)(1)), because they are intended to prevent disease, as described above. In addition, these products are "new drugs," as defined by section 201(p) of the Act. (21 U.S.C. § 321(p)), because we are not aware of sufficient evidence to show that that they are. generally recognized as safe and effective for these labeled uses. In particular, we are not aware of evidence that these products are safe and effective in preventing.individuals from becoming infected with Hepatitis A, B, and C, HIV-1 (AIDS virus), methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), and the other diseases listed in the product labeling. Under sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 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. "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" do not have approved applications and their introduction and delivery for introduction into interstate commerce violates these provisions of the Act.

For your information, OTC health care antiseptics, which include antiseptic cleansers, and OTC first aid antiseptics are being evaluated under FDA's OTC Drug Review. Tentative final monographs (TFMs) for these products were published in the Federal Register of June 17, 1994 (59 FR 31402) and July 22, 1991 (56 FR 336444). These TFMs are available on FDA's Internet website at www.fda.gov/cder/otcmonographs/category_sort/antimicrobial.htm. However, although the active ingredient in "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" (i.e., isopropyl alcohol) is covered by these ongoing rulemakings for certain topical antimicrobial uses, the claims referenced above are not.

Pending a final monograph for OTC health care antiseptics, we would, not object to the marketing of an isopropyl alcohol-containing OTC antiseptic handwash in either a spray or wipe form that meets the provisions of the TFM for OTC health care antiseptics and is offered as follows: "For handwashing to decrease bacteria on the skirt" (which may be followed by one or more of the following: "after changing diapers," "after assisting ill persons," or "before contact with a person under medical care or treatment"). Nor would we object to the marketing of an isopropyl alcohol-containing OTC health-care personnel handwash in either a spray or wipe form that meets the provisions of the TFM for OTC health care antiseptics and is offered as follows: "Handwash to help reduce bacteria that potentially can cause disease" or "For handwashing to decrease bacteria on the skin" (which may be followed by one or more of the following: "after changing diapers," "after assisting ill persons," or "before contact with a person under medical care or treatment"). Such marketing, however, is subject to the risk that a final monograph or rule may require reformulation and/or relabeling or FDA approval through the "new drug" procedures of the Act (section 505).1

Moreover, the antifungal claim noted above -"Tricophyton mentagnophytes (Athletes foot fungus)" - subjects these products to the requirements of the final monograph for. over-the-counter (OTC) Topical Antifungal Drug Products (21 C.F.R. Part 333, Subpart C). "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" are neither formulated nor labeled in conformance with this final monograph. Therefore, they are not generally recognized as safe and effective and are "new drugs" under section 201(p) of the Act (21 U.S.C. § 321(p)). As noted above, the marketing of these products without FDA-approved applications violates section 505(a) and 301(d) of the Act. Further, these products are misbranded under sections 502(f)(1) and (2) of the Act (21 U.S.C. §§ 352(f)(1) and (2)), because they do not bear the indications, directions, and warnings required by the final monograph for OTC Topical Antifungal Drug Products: See 21 C.F.R. § 333.250.

In addition to the representations noted above, the package labeling for "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" includes the following statement:

"Acceptable under OSHA bloodborne pathogen standard and CDC guidelines"

We acknowledge the requirements under 29 C.F.R. § 1910.1030, the "OSHA Bloodborne Pathogens Standard," enforced by the U.S. Occupational Safety and Health Administration. That standard, however, does not authorize any disease-prevention claims on the labeling of products like "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes." Further, this OSHA standard does not affect the new drug application requirements under section 505 of the Act (21 U.S.C. § 355).

Regarding claims that "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes" are acceptable under guidelines issued by the Centers for Disease Control and Prevention (CDC), as reflected by the above statement, we acknowledge the existence of that agency's guideline titled "Guideline for Hand Hygiene in Health-Care Settings." Like many CDC guidelines, this one is intended to assist health-care professionals. The guideline discusses the possible efficacy of "alcohol hand rubs," but it does not specifically recommend their use in preventing the diseases caused by the specific microorganisms referenced in the labeling and promotion for "DuPont RelyOn Antiseptic Spray" and "DuPont RelyOn Antiseptic Hand Wipes." Rather, the guideline provides a general recommendation that "alcohol hand rubs" be used, among other things, "to reduce the transmission of pathogenic microorganisms to patients and personnel in health-care settings," and only if hands are not visibly dirty or contaminated with proteinaceous material or soiled with blood or other body fluids. Further, the guideline acknowledges the need for additional data and study to substantiate specific antimicrobial claims and that differing formulations can affect a product's efficacy. It does not authorize or recommend the inclusion of disease-prevention. claims like the ones described above on product labeling. Nor does the guideline affect the new drag application requirements under section 505 of the Act (21 U.S.C. § 355).

The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your reply should be directed to: James C. Illuminati, Compliance Officer, Philadelphia District Office, RM904 HFR-CE140, U.S. Custom House, Room 900, 200 Chestnut Street, Philadelphia, PA, 19106-2973

Sincerely

/S/

Thomas D. Gardine
District Director
Philadelphia District Office

____________________
1 We note that the claims on your product differ from the above-described claims in the OTC health care antiseptic and OTC first aid antiseptic TFMs in numerous significant ways. For example, your product claims include numerous viruses, such as Hepatitis A, B, and C and HN-1 (AIDS virus), but no viruses are covered by the acceptable claims in these TFMs. In addition, with respect to any bacteria claims, the acceptable claims under the OTC health care and first aid antiseptic TFMs do not quantify the degree of effectiveness of the products. Your product labeling, though, states that they are "99% effective" in killing various bacteria, as well as viruses and fungus. Furthermore, your product labeling supports these claims only "based on in-vitro testing." However, both in-vitro and in-vivo testing would be required to support those bacteria claims listed in the health care antiseptic TFM. Even if you had such data, though, your above-noted antimicrobial claims do not conform with the TFM.