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WARNING LETTER

Soaptronic LLC MARCS-CMS 596450 —


Delivery Method:
VIA SIGNATURE CONFIRMED DELIVE
Product:
Drugs

Recipient:
Recipient Name
Barbara Binderbauer
Recipient Title
Owner / CEO
Soaptronic LLC

20562 Crescent Bay Drive
Lake Forest, CA 92630-8845
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States


WARNING LETTER


December 12, 2019

Dear Ms. Binderbauer:

This letter concerns your firm’s marketing of the Germstar product line that includes the over-thecounter (OTC) drug products, “germstar ORIGINAL,” “germstar Citrus,” “germstar NORO,” “germstar Tropical,” germstar Juicy,” “germstar Pink,” “germstar Refresh,” “germstar Breeze,” and “germstar Luxe.” These products are collectively referred to as “Germstar Hand Sanitizers” or “Germstar Hand Sanitizer products” in this letter and are sold in a variety of sizes and package configurations.1 Based on claims on your product website where these products may be purchased, you intend these products for use as consumer and healthcare antiseptics.

As currently formulated and labeled, Germstar Hand Sanitizers are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). These violations are described in more detail below.

Unapproved New Drugs

Examples of claims observed on your product website, www.germstar.com, for Germstar Hand Sanitizers that provide evidence of the intended uses of the products as defined in 21 CFR 201.128 include, but may not be limited to, the following:

“HOME . . . With an ever-increasing rise of outbreaks such as Norovirus, E Coli, and a growing threat from foreign germs, viruses, and bacteria, Germstar® recognized the solution was to prevent initial contamination. It is far more effective to prevent infection rather than remedy it later. . . .ABOUT . . . Germstar kills 99.9% of all transient bacteria, viruses and fungus on contact and has been proven to kill: • H1N1 (Swine Flu) • Norovirus (winter vomiting bug) • Gastroenteritis • E Coli • Salmonella • MRSA...and many more . . . In recent years we have seen the ever increasing rise of outbreaks of Norovirus and E Coli. Germstar® provides protection for everyone in the fight to kill germs transmitted via the hands, which accounts for 80% of transmission.”

Additional evidence of intended use for “germstar NORO” on your product website, www.germstar.com include, but may not be limited to, the following:

“GERMSTAR NORO PRODUCT DESCRIPTION . . . Germstar® Noro has been formulated and engineered to kill Noro virus within 20 seconds upon contact, leaving hands sanitized and moisturized with a light Spearmint fragrance . . . • Originally designed for the cruise line industry to protect ship’s passengers from the highly contagious Noro virus”

Based on the above claims, Germstar Hand Sanitizers are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body. Specifically, Germstar Hand Sanitizers are intended for use as consumer antiseptic rubs and health care antiseptic rubs.

Furthermore, Germstar Hand Sanitizer products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the Act, 21 U.S.C. 355, are in effect for your Germstar Hand Sanitizer products, nor are we aware of any adequate and well controlled clinical trials in the published literature that support a determination that Germstar Hand Sanitizer products are generally recognized as safe and effective for their labeled indications. Accordingly, Germstar Hand Sanitizer products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

We note that your website suggests that Germstar Hand Sanitizer products are marketed under the OTC Drug Review and they are formulated with either isopropyl alcohol or ethyl alcohol. For OTC drug products intended for use as consumer antiseptic rubs, on April 12, 2019, FDA published the Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020). FDA deferred benzalkonium chloride, ethyl alcohol, and isopropyl alcohol from consideration in the 2019 Consumer Antiseptic Rub Final Rule (for additional information, see Docket No. FDA–2016–N–0124 at https://www.regulations.gov).

For OTC drug products intended for use as health care antiseptics, on December 20, 2017, FDA published the Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (82 FR 60474, December 20, 2017). In the 2017 Final Rule for Health Care Antiseptics, FDA announced it had deferred rulemaking on six active ingredients for specific OTC Health care antiseptic uses. Included in those six active ingredients are alcohol (also referred to as ethanol or ethyl alcohol) and isopropyl alcohol for use in a health care personnel hand rub or surgical hand rub.

Pending the promulgation of a final rule establishing whether isopropyl alcohol and ethyl alcohol are Generally Recognized As Safe and Effective (GRASE) for the antiseptic uses described above, the agency generally does not intend to object to the marketing of products that meet both the proposed formulation and labeling conditions described in the relevant tentative final monograph (TFM) or that are otherwise eligible for inclusion in the OTC Drug Review (see 68 FR 75585 at 75590-91, December 31, 2003) and each general condition in 21 CFR 330.1, unless a particular product constitutes a hazard to health. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval pursuant to Section 505 of the FD&C Act, 21 U.S.C. 355. However, the Germstar Hand Sanitizer products do not comply with the relevant TFM.

The claims on your product website for Germstar Hand Sanitizers that purport effectiveness in preventing disease or infection from pathogens such as H1N1 swine flu, MRSA, salmonella, and norovirus go beyond merely describing the general intended use of a topical antiseptic as described in the above referenced relevant rulemakings. Such claims are not described in any OTC final rule, the above referenced TFM (see 59 FR 31402, June 17,1994), or any rulemakings being considered under the OTC Drug Review. Additionally, we are not aware of any adequate and well controlled clinical trials in the published literature that support a determination that Germstar Hand Sanitizers are generally recognized as safe and effective for their labeled indications. Furthermore, we are not aware of a similar OTC product as formulated and labeled that was available in the United States market on or before the inception of the OTC Drug Review.

Therefore, as formulated and labeled, the Germstar Hand Sanitizer products are not covered under any OTC monograph or ongoing rulemaking that sets forth conditions for general recognition of safety and effectiveness for such uses. Nor are products intended specifically for effectiveness in preventing disease or infection from specific pathogens, such as MRSA, H1N1 swine flu and norovirus, being considered under FDA's OTC Drug Review. Furthermore, we are not aware of evidence to show that Germstar Hand Sanitizer products as formulated and labeled are generally recognized by qualified experts as safe and effective for their labeled uses.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of deficiencies regarding your products. Please be aware that 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.

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, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. 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.

Send your electronic reply to ORAPHARM4_Responses@fda.hhs.gov or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Irvine, CA 92612

Please identify your response with unique identifier 596450.

If you have questions regarding any issues in this letter, please contact CAPT Matthew R. Dionne, Compliance Officer, at (303)-236-3064, or Matthew.Dionne@fda.hhs.gov.

Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
 

__________________________

1 This includes 8mL pens; 2oz spray bottles; 16oz pump bottles; Luxe twist top bottles; 4oz refills; 12oz refills; 32oz refills; 12oz starter kits; and 32oz starter kits.