| Public Health Service Food and Drug Administration |
Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2761 |
Department of Health and Human ServicesApril 18, 2011
VIA UPS
WARNING LETTER
CIN-11-123168-10
Douglas Nelson, President and CEO
JD Nelson and Associates, LLC
129 E College Ave, Suite 200
Westerville OH 43081
Dear Mr. Nelson:
This letter concerns your firm's marketing of the Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant. As presently formulated, labeled and promoted, these over-the-counter (OTC) products violate the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, these products are unapproved new drugs in violation of section 505(a) of the Act [21 U.S.C. § 355(a)].
Below is an analysis of the regulatory status of Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant which includes excerpts of the violative labeling and the specific new drug charges. Note that this is not an all-inclusive description of violative labeling for your OTC drug products.
Safe4Hours Hand Sanitizing Lotion
The product labeling for Safe4Hours Hand Sanitizing Lotion represents the product as an OTC topical antimicrobial hand antiseptic with the active ingredient triclosan, 1%. The product's use is described in the product name itself, Safe4Hours Hand Sanitizing Lotion, and the following statement on its label:
"KILLS 99% OF GERMS"
Your website (http://www.safe4hours.com) includes the following statements about Safe4Hours Hand Sanitizing Lotion and its uses:
"Alcohol Free Hand Sanitizer Safe4Hours® Hand Sanitizer is effective against a broad spectrum softest pathogens, including MRSA."
"Alcohol Free, Hand Sanitizer Safe4Hours® Hand Sanitizer is effective against a broad spectrum of test pathogens including the MRSA, E. Coli, and Staphylococcus aureus."
"Is Safe4Hours® Hand Sanitizer effective against MRSA?
Yes. We have tested Safe4hours Hand Sanitizer extensively and have shown the ability to kill and protect against MRSA."
"Is Safe4Hours® Hand Sanitizer effective against H1N1/Swine Flu?
Currently, no hand sanitizers are specifically designated to protect against H1N1. However the Centers for Disease control and Prevention (CDC) recommends products like Safe4Hours® Hand Sanitizer to help stop the spread of H1N1 when soap and water are unavailable ... "
"Safe4Hours® Hand Sanitizer helps prevent Occupational Hand Disease (OHD) in environments where repetitive contact with water and detergents can damage skin, such as health care and food handling facilities."
Based on the labeling described above, Safe4Hours Hand Sanitizing Lotion is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent disease or to affect the structure or function of the body of man.
We are not aware of sufficient evidence demonstrating that this product is generally recognized as safe and effective as a topical antimicrobial that can prevent infection from E. coli, Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus; or prevent "Occupational Hand Disease;" or mitigate, prevent, treat or cure the H1N1 Flu Virus in people.
Thus, Safe4Hours Hand Sanitizing Lotion is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321 (p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)].
For your information, OTC topical antimicrobials, including OTC healthcare antiseptics 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 59 Fed. Reg. 31402 (June 17, 1994) and 56 Fed. Reg. 336444 (July 22, 1991). These TFMs are available on FDA's Internet website at:
Pending a final monograph, the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the relevant TFM1. However, your product's formulation and labeling are not consistent with either of the TFMs referenced above.
The active ingredient in Safe4Hours Hand Sanitizing Lotion, i.e., triclosan, is being evaluated for certain topical antimicrobial uses under these ongoing rulemakings, but the claims referenced above and the directions to "leave ... on" without rinsing with water are not. In particular, the safety and effectiveness of triclosan in antimicrobial hand cleansers, when followed by rinsing with water, is being evaluated under the OTC Drug Review. However, the directions for use for Safe4Hours Hand Sanitizing Lotion do not instruct the user to rinse with water after application; rather, it states that the product is to be applied to the hands and allowed to dry without wiping.
The claims for Safe4Hours Hand Sanitizing Lotion referenced above, including the product name that asserts multiple hours of extended efficacy as a hand sanitizer, and the directions to "leave ... on" without rinsing with water are not being considered under the OTC Drug Review because we are not aware of any products with such labeling that existed in the marketplace in the United States on or before the inception of the OTC Drug Review, or that have complied with the requirements under 21 C.F.R. § 330.14.
Safe4Hours First Aid Antiseptic Skin Protectant
The product labeling for Safe4Hours First Aid Antiseptic Skin Protectant represents the product as a combination topical skin protectant and first aid antiseptic, with the active ingredients allantoin 1% and triclosan 1%, respectively.
The product's uses are described in the product name itself; Safe4Hours First Aid Antiseptic Skin Protectant, and the following statements on its label:
"Allantoin 1% Skin protectant
Triclosan 1% First aid antiseptic"
"Uses first aid to help prevent infection in minor: cuts scrapes bums"
"Uses skin protectant...helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin...helps prevent and protect from drying effects of wind and cold weather"
"Long-Lasting POWERFUL ANTISEPTIC AND SOOTHING ANTIBACTERIAL SKIN PROTECTANT IN ONE"
"Patented technology forms a long-lasting protective barrier on skin"
Your website includes the following statements about Safe4Hours First Aid Antiseptic Skin Protectant and its uses:
"Safe4Hours® is effective against a broad spectrum of pathogens, including MRSA."
"How can I protect myself from MRSA... Treat any open wound immediately apply Safe4Hours® First Aid Antiseptic Skin Protectant as quickly as possible. We recommend that you re-apply Safe4Hours® First Aid Antiseptic Skin Protectant 3 times daily or as necessary."
The above statements demonstrate that Safe4Hours First Aid Antiseptic Skin Protectant is a "drug" as defined by section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because it is intended to prevent disease or to affect the structure or function of the body of man.
In addition, based on the product's labeling, Safe4Hours First Aid Antiseptic Skin Protectant is subject to the requirements of the OTC Final Monograph for Skin Protectant Drug Products (21 C.F.R. Part 347). However, Safe4Hours First Aid Antiseptic Skin Protectant is not labeled in conformance with this final monograph.
Furthermore, we are not aware of sufficient evidence that shows this product is generally recognized as safe and effective as a topical skin protectant and first aid antiseptic for preventing infection from Methicillin Resistant Staphylococcus aureus (MRSA).
Therefore, Safe4Hours First Aid Antiseptic Skin Protectant is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and may not be legally marketed in the United States without an approved application under section 505(a) of the Act [21 U.S.C. § 355(a)].
For your information, the OTC Final Monograph for Skin Protectant Drug Products (21 C.F.R. Part 347) allows for certain combinations of skin protectant active ingredients with first aid antiseptic active ingredients provided that, among other things, such combinations are only offered for the applicable uses described in 21 C.F.R. §§ 347.50(b)(1) and 347.60(b)(2) (e.g., to protect minor cuts, scrapes, and bums). Safe4Hours First Aid Antiseptic Skin Protectant does not comply with the final monograph in this regard. Moreover, the product name suggests that the product provides multiple hours of extended efficacy as a combination topical skin protectant and first aid antiseptic. You must ensure your OTC topical skin protectant and first aid antiseptic combination products are consistent with the OTC Final Monograph for Skin Protectant Drug Products.
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products, nor are the arguments raised here regarding them exhaustive. 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. If you no longer manufacture or market any of your drug products, your response should so indicate, including the reasons for, and the date on which, you ceased production.
Your reply should be sent to: Mr. Stephen J. Rabe, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about the content of this letter, please contact Mr. Rabe at (513)679-2700 extension 163 or you may forward a facsimile to him at (513)679-2773.
You can find guidance and information regarding regulations through links at FDA's Internet website at http://www.fda.gov/oc/industry.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
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