WARNING LETTER
Blue Willow Biologics
MARCS-CMS 613948 —
August 03, 2021
Product:
Drugs
Recipient:
Recipient Name
Chad Costley, MD/MBA
Recipient Title
President and Chief Executive Officer
Blue Willow Biologics
2311 Green Road
Ann Arbor
,
MI
48105
United States
nanobio@bluewillow.com
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
Date: August 3, 2021
RE: Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) had reviewed your websites at the Internet addresses https://nanobioprotect.com and https://bluewillow.com on March 24, 2021. The FDA observed that your websites offered a non-alcohol-based consumer antiseptic nasal product
1
for sale in the United States and that this product was intended to mitigate, prevent, treat, diagnose, or cure COVID-19
2
and other conditions in people. FDA also observed that your product is for sale in the United States on other websites, including at https://www.cvs.com/shop/nanobio-protect-nasal-antiseptic-prodid-160333. Based on our review, this product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee). Introduction or delivery for introduction of such a product into interstate commerce violated sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d). These violations are described in more detail below.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
3
In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.
4
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sold an unapproved and unauthorized product that was intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions in people.
Some examples of the claims on your product label that establish the intended use of your product (as defined in 21 CFR 201.128) and examples of the claims on your website that established the intended use of your product and misleadingly represented it as safe and/or effective for the treatment or prevention of COVID-19 and other serious infections include, but may not be limited to, the following:
NanoBioProtect.com and Bluewillow.com websites and NanoBio Protect Nasal Antiseptic label:
NanoBio® Protect Over-The-Counter Nasal Antiseptic Kills COVID-19 Virus in Lab Tests.” [from your website https://bluewillow.com/%ef%bb%bf%ef%bb%bfnanobio-protect-over-the-counter-nasal-antiseptic-kills-covid-19-virus-in-lab-tests/]
“Recent studies conducted by Public Health England also demonstrate NanoBio® Protect’s ability to kill COVID-19 virus in laboratory test.” [from your website https://bluewillow.com/nanobio-protect/]
“NanoBio Protect . . . Protects for up to 8 hours . . . Kills 99.99% of germs on contact . . . Reduces the risk of respiratory infection ….” [from your website https://nanobioprotect.com/]
“KILLS GERMS THAT ENTER THE NOSE . . . PROTECTS FOR 8 HOURS . . .NEXT-LEVEL PROTECTION AGAINST INFECTION” [from your product label]
“Get protection from infection that lasts all day.” [from your website https://nanobioprotect.com/]
“NanoBio Protect offers next-level protection to help keep you and your family healthy. It is the only alcohol-free nasal antiseptic proven to kill 99.99% of infection-causing germs when applied to the skin in and around the nose. . . NanoBio Protect uses patented, natural-oil nanodroplets that deliver the antiseptic directly to the surface of germs, killing them on contact. Uniquely, the nanodroplets remain active on the skin after application for up to 8 hours (in lab testing), providing lasting protection against the germs that cause infection.” [from your website https://nanobioprotect.com/frequently-asked-questions/]
“NanoBio Protect adds BZK antiseptic to the surface of nanodroplets. This technology offers four distinct advantages over conventional BZK antiseptics:
The Nanodroplets optimize the ability of the antiseptic to kill germs. The droplets sit on skin after application, enabling protection for up to 8 hours (in lab testing) . . .” [from your website https://nanobioprotect.com/frequently-asked-questions/]
“Is NanoBio Protect US FDA regulated? Yes. NanoBio® Protect nasal antiseptic adheres to the OTC monograph system for topical skin antiseptics. In testing by independent FDA registered laboratories, NanoBio® Protect was shown to kill 99.99% of a broad spectrum of pathogenic organisms. To learn more, visit https://bluewillow.com/nanobio-protect/.” [from your website https://nanobioprotect.com/frequently-asked-questions/]
We note that, as of the date of this letter, some of the claims cited above appear to have been removed. Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that these violations do not recur.
Based on the above claims, your topical antiseptic 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. Specifically, your product is intended for use as a consumer topical antiseptic.
This consumer topical antiseptic is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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), unless they are lawfully marketed under section 505G of the FD&C Act (which is not the case for this product, as further described below) or under other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your NanoBio Protect Nasal Antiseptic Solution product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug 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 over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016)(Consumer Antiseptic Rubs Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.
However, your consumer topical antiseptic product does not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
Specifically, your labeling claims suggesting and depicting that your topical antiseptic product is effective in preventing infection or disease go beyond merely describing the general intended use of consumer antiseptics as set forth in the 1994 TFM.5 Your claims on the product label, suggesting your consumer antiseptic provides all day efficacy against infection, and your claims on your websites, which suggested all day protection against serious-disease related pathogens including the novel coronavirus that causes COVID-19, do not conform to the 1994 TFM or any of the amendments to the TFM discussed above. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, endanger the public health by creating a false sense of security for the general public that may result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms. As a result, this product may have given users the false impression that they need not rigorously adhere to interventions such as social distancing and exercising good hygienic practices that have been demonstrated to curb the spread of COVID-19. Users who did not follow these interventions were at increased risk for contracting COVID-19 and for spreading disease if they had been exposed to the virus, thereby prolonging the pandemic, and increasing its associated morbidity and mortality. In addition, according to the product labeling, NanoBio Protect Nasal Antiseptic Solution is intended to be applied inside and around the nostrils. Consumer antiseptic products intended for administration inside and around the nostrils are not permitted under the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule
6
.
We are unaware of any adequate and well-controlled clinical studies in the published literature that support a determination that your consumer topical antiseptic product is GRASE for the above-described intended uses, including the time-specific extended efficacy claims. Accordingly, your consumer topical antiseptic product is a new drug under section 201(p) of the FD&C Act. In addition, there are no FDA-approved applications in effect for your consumer topical antiseptic product and, accordingly, it is an unapproved new drug sold 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 consumer topical antiseptic product also does not conform to any temporary policy FDA has implemented for alcohol-based hand sanitizer products during the public health emergency.
7
This consumer topical antiseptic product was also misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because the labeling was false or misleading. Specifically, labeling for this product claimed that the product “adheres to the OTC monograph system for topical skin antiseptics.” As noted above, this product does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.
This consumer topical antiseptic products is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
You should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.
Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov
describing the specific steps you have taken to prevent the recurrence of future violations. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure, and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act, with a notation that, as of the date of this letter, your firm’s listed products are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of COVID-19. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.Corrective actions taken to address the sale of your unapproved and unauthorized product for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have to be confirmed by the FDA, for the published list to be updated to indicate that your firm has taken such corrective actions.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. 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 are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_______________________________
1
Your non-alcohol-based consumer antiseptic nasal product is NanoBio Protect Nasal Antiseptic Solution.
2
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
3
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists. (originally issued on Jan. 31, 2020 and subsequently renewed) available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak. (Mar. 13, 2020), available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
5
The 1994 TFM covers health care antiseptics that are indicated for use to help reduce bacteria that potentially can cause disease and health care and consumer antiseptics that are indicated for use to decrease bacteria on the skin. 59 FR at 31443.
6
The 2016 Consumer Antiseptic Rubs Proposed Rule covered consumer antiseptic products intended for use of without water. Under the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, only consumer topical antiseptic products intended for use on the hands without water are permitted. Products intended for other areas of the body such as the nose are not permitted.
7
See, e.g.,
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
. Because your consumer topical antiseptic product is not consistent with the formulations described in these guidances, it does not fall within any temporary Agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 505 of the FD&C Act.
Content current as of:
08/04/2021
Regulated Product(s)
Drugs