Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526069.htm
Timestamp: 2019-01-18 18:52:47
Document Index: 366146433

Matched Legal Cases: ['§ 331', '§ 321', '§ 321', '§ 321', '§ 360', '§ 331', '§ 355', '§ 321', '§\n321', 'art 333', '§ 321', '§ 355', '§ 355', '§ 331']

ITW Dymon 10/19/16
VIA UNITED PARCEL
SERVICE SIGNATURE REQUIRED
CMS CASE 494201
Mr. Paul M. Taylor
Vice President and Group General Manager
805 E Old 56 Hwy
This letter concerns your firm’s manufacturing and marketing of the nonprescription (or over-the-counter (OTC)) drug products “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” and “SCRUBS® Hand Sanitizer Wipes.”
As described below, these products are unapproved new drugs. Your firm’s introduction of these unapproved new drugs into interstate commerce is in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(d) and 355(a)].
SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+
Unapproved New Drug Charge
“SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” is an unapproved new drug because the product is ineligible for the OTC Drug Review for Sunscreens, it is not generally recognized as safe and effective (GRASE) for use to help provide protection from sunburn, and we are not aware of an FDA-approved application on file for this product. As such, the use of “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” may not help protect consumers from sunburn and may cause users to be susceptible to sunburn and other disease conditions.
The labeling for “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” states “Provides high protection against sunburn” and “SPF 30+.” Based on this labeling, this product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)], because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. § 321(g)(1)(C)] because it is intended to affect the structure or any function of the body of man. Specifically, this product is intended to provide protection from sunburn.
Based on the claims made for this product, “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” is a “new drug” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because it has not been used to a material extent or for a material time for its labeled use to provide protection against sunburn, and also because it is not generally recognized as safe and effective for that use. The newness of a drug may arise among other reasons by reason of the newness of a dosage or method or duration of administration or application [see 21 CFR 310.3(h)(5)].
As the Agency specifically noted in 2011, nonprescription drug products intended for use to help prevent sunburn that are marketed in dosage forms including wipes are currently ineligible for the OTC Drug Review for Sunscreens because FDA is not aware of evidence that a sunscreen in a wipe dosage form existed in the OTC drug marketplace on or before May 1972 (76 FR 35669 at 35671, June 17, 2011). In addition, OTC sunscreen products in this dosage form have not established eligibility for review under the Time and Extent Application (TEA) process (21 CFR 330.14(c)) or under the procedures set out in the Sunscreen Innovation Act (SIA) (21 U.S.C. § 360fff), because we have not received any TEAs or requests for review under the SIA for these products. OTC sunscreen products in this dosage form that are marketed without an approved application therefore remain subject to regulatory action unless and until the requirements of 21 CFR 330.14(h) or the SIA are satisfied.1
Under sections 301(d) and 505(a) of the FD&C 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 application approved by FDA under section 505(b) or 505(j) of the FD&C Act [21 U.S.C. §§ 355(b or 355(j))] is in effect for the product. Without such an application, there is a lack of adequate data to establish eligibility of or general recognition of the safety and effectiveness of “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” for OTC use to help prevent sunburn. Therefore, this product may not help protect consumers from sunburn, and may cause consumers to be susceptible to sunburn and other disease conditions caused by the sun.
Based on our information, there is no FDA-approved application on file for “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+.” The marketing of this product without an approved application violates these provisions of the FD&C Act.
SCRUBS® Hand Sanitizer Wipes
The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution. See, e.g., 21 CFR 201.128. The product’s name, “SCRUBS® Hand Sanitizer Wipes,” and the following claims on the product’s label that reflect the intended use include, but are not limited to, the following:
“Active Ingredients… n-alkyl dimethyl benzyl ammonium chloride…Antiseptic… n-alkyl dimethyl ethyl benzyl ammonium chloride…Antiseptic . . . Kills 99.9% of Disease Causing Germs . . . Kills MRSA . . . Antibacterial . . . SCRUBS Hand Sanitizer Wipes unique formula reduces the risk of infection by killing 99.9% of disease causing organisms: . . . Pseudomonas aeruginosa – (10 seconds) . . . Staphylococcus Aureus – (10 seconds) . . . Escherichia Coli – (20 seconds) . . . Streptococcus pyogenes – (10 seconds) . . . Salmonella choleraesuis – (10 seconds) . . . Candida albicans – (10 seconds) . . . MRSA - Methicillin-resistant Staphylococcus Aureus (MRSA) (10 seconds)”
Based on the above claims, the product “SCRUBS® Hand Sanitizer Wipes” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and as defined by section 201(g)(1)(C) of the FD&C Act [21 U.S.C. §
321(g)(1)(C)] because it is intended to affect the structure or any function of the body. Specifically, “SCRUBS® Hand Sanitizer Wipes” is intended as a topical antiseptic and as an antifungal.
The claims noted above include a claim to decrease the number of fungi of the species Candida albicans, (… unique formula reduces the risk of infection by killing 99.9% of disease causing organisms… [including] Candida albicans). This antifungal claim subjects “SCRUBS® Hand Sanitizer Wipes” to the requirements of the OTC Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human Use: Topical Antifungal Drug Products (21 CFR Part 333 Subpart C). See 21 CFR 333.203(a). “SCRUBS® Hand Sanitizer Wipes” is neither formulated nor labeled in conformance with this final monograph. For example, its active ingredients are not included as permissible antifungal active ingredients in the final monograph. See 21 CFR 333.210. In addition, the indications permitted in labeling under this monograph do not include claims for effectiveness in treatment of Candida albicans. See 21 CFR 333.250. In addition, the combination of an antifungal and topical antiseptic is not allowed under the antifungal final monograph.
Furthermore, OTC consumer drug products intended for topical uses such as the labeled indication of the “SCRUBS® Hand Sanitizer Wipes,” i.e., reduction of bacteria on the skin, are being evaluated under the ongoing rulemaking for OTC Topical Antimicrobial Drug Products as part of FDA’s OTC Drug Review. OTC Topical Antimicrobial Drug Products include OTC healthcare antiseptics, OTC consumer washes, and OTC consumer rub products (which includes consumer antiseptic wipes similar to “SCRUBS® Hand Sanitizer Wipes”). Tentative final monographs (TFMs) for these products were first published in the Federal Register in 43 FR 1210 (January 6, 1978) and amended at 56 FR 33644 (July 22, 1991), 59 FR 31402 (June 17, 1994), 78 FR 76446 (December 17, 2013), 80 FR 25166 (May 5, 2015) and 81 FR 42911 (June 29, 2016).
Pending a final monograph,2 the agency does not object to the marketing of OTC drugs that meet the formulation and labeling requirements described in the relevant TFM or that are otherwise eligible for inclusion in the OTC Drug Review (see 68 FR 75585 at 75590-91, Dec. 31, 2003). However, “SCRUBS® Hand Sanitizer Wipes” is not formulated or labeled in accordance with the rulemakings mentioned above for the reasons described below. Specifically, n-alkyl dimethyl ethyl benzyl ammonium chloride is not proposed as an eligible active ingredient in any of the antiseptic rulemakings described above. Therefore, the antiseptic rulemakings do not propose that alkyl dimethyl benzyl ammonium chloride (benzalkonium chloride) and n-alkyl dimethyl ethyl benzyl ammonium chloride are GRASE for any of the indications found in the antiseptics rulemakings when combined. Secondly, claims to the public, as referenced above, for effectiveness in reducing infections caused by MRSA, Escerichia coli, Streptococcus pyogenes, Salmonella choleraesuis, Staphylococcus aureus, and Pseudomonas aeruginosa go beyond merely describing the general intended use of a topical antiseptic as described in the relevant rulemaking.
Thus, “SCRUBS® Hand Sanitizer Wipes,” as formulated and labeled, does not comply with the final monograph for Topical Antifungal Drug Products (21 CFR 333) Subpart C, nor does it conform to the TFMs for OTC Health Care Antiseptic Drug Products, the OTC Consumer Antiseptics Drug Products; nor to any other final or tentative final monograph under the OTC Drug Review. Further, we are not aware of sufficient evidence to show “SCRUBS® Hand Sanitizer Wipes,” as formulated and labeled, is generally recognized as safe and effective. As noted above, we are also not aware of any marketing of a product formulated and labeled like “SCRUBS® Hand Sanitizer Wipes” on or before the inception of the OTC Drug Review. As a result, the product is not deferred to the OTC Drug Review for such indications. Therefore, “SCRUBS® Hand Sanitizer Wipes” is a “new drug” under section 201(p) of the FD&C Act [21 U.S.C. § 321 (p)] and because it is not, based on our information, the subject of an FDA-approved application submitted under section 505(b) or 505(j) [21 U.S.C. § 355(b), 355(j)], its marketing in the United States violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. Introduction of this product into interstate commerce is a violation of section 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance 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.
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 violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute “SCRUBS® SOLAR GUARD™ Sunscreen Wipe SPF 30+” and “SCRUBS® Hand Sanitizer Wipes,” and provide the date(s) and reason(s) you ceased production.
Please send your reply to the attention of:
Miguel Hernandez, Director, Compliance Branch
If you have questions regarding this letter, please contact Mr. Eric Mueller, Compliance Officer at 402-331-8536 ext. 101 or eric.mueller@fda.hhs.gov
1 For general information on the Agency’s proposed approach to the enforcement of nonprescription sunscreen products marketed without approved applications see Draft Guidance for Industry: Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application , available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm259001.pdf (published for notice and comment purposes only).
2 Once a final monograph becomes effective, it may be necessary to reformulate and/or relabel such products to conform to its requirements, or, in the alternative, to seek FDA approval of a new drug application (NDA) under section 505 of the FD&C Act [21 U.S.C. 355].
ITW Dymon - Close Out Letter 1/11/17
Page Last Updated: 01/13/2017