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  1. Warning Letters

WARNING LETTER

Novid Group, Inc. MARCS-CMS 672251 —

Product:
Drugs

Recipient:
Recipient Name
Marc Kerner
Recipient Title
President
Novid Group, Inc.

18350 Roscoe Blvd. Suite 318
Northridge, CA 91325-4164
United States

hello@getnovid.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

December 7, 2023

Re: Case # 672251

Dear Dr. Kerner:

This letter concerns your firm’s distribution of the over-the-counter (OTC) combination antihistamine and nasal decongestant drug product novid NASAL SPRAY.1 The United States Food and Drug Administration (FDA) reviewed your website on October 12, 2023 at the Internet address https://getnovid.com/ where the product is available for purchase.

novid NASAL SPRAY is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act,) 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug Violations

novid NASAL SPRAY 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/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, this product is intended for use as a combination antihistamine and nasal decongestant drug product.

Examples of claims from your website https://getnovid.com/ that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

Drug Facts . . . Uses . . . ■ temporarily relieves symptoms of upper airway allergies and infections which include: ■ runny nose ■ nasal congestion ■ sinus pressure” [from your website https://getnovid.com/]

Benefits • Relieves runny, itchy nose • Controls nasal congestion • Reduces or eliminates the symptoms of allergies, colds, and sinus infections caused by viruses or bacteria.” [from your website https://getnovid.com/]

How can I use Novid for nasal protection? This is a concept of providing yourself individual protection from catching colds or other viral infections when in a large crowd or in close contact with potentially infected individuals. If you know that you are going to be in a large crowd, you can use Novid™ nasal spray prior to exposure and afterwards to provide some personal protection.” [from your website https://getnovid.com/]

“The Doctor recommended and approved Nasal and Sinus Protection spray that fights and defends where viruses and bacteria attack” [from your website https://getnovid.com/]

“The only nasal spray that is effective in reducing inflammation. Likely the #1 cause for symptoms resulting from disease.” [from your website https://getnovid.com/]

“Novid™ is formulated with a patented ingredient, Fulvic Gold, which enhances the immune-enhancing activity of the nasal spray. It is a safe and effective ingredient that augments our immune cellular activity.” [from your website https://getnovid.com/]

Based on the above labeling claims, novid NASAL SPRAY is intended for use as a combination antihistamine and nasal decongestant drug product. As described below, novid NASAL SPRAY 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).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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 identified above.

Your novid NASAL SPRAY drug product is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “OTC monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to OTC antihistamine and nasal decongestant drug products, such products are deemed to be generally recognized as safe and effective (GRASE) and not a new drug if, among other things, they conform to the conditions of use set forth in monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (henceforth “M012” or the cold, cough monograph).2

However, novid NASAL SPRAY does not conform to the conditions of use specified in M012 for the reasons described below.

novid NASAL SPRAY is neither formulated, nor labeled in conformance with M012. For example, novid NASAL SPRAY’s labeled active ingredients (i.e., sodium chloride and organic fulvic acids) do not comply with M012. Specifically, sodium chloride and organic fulvic acids are not permitted active ingredients under M012 when used in combination, or as sole ingredients, for any OTC antihistamine or nasal decongestant drug product.

In addition, the labeling for novid NASAL SPRAY includes intended use claims that are not permitted under M012. For example, the labeling for your drug product states that novid NASAL SPRAY, “…fights and defends where viruses and bacteria attack,” provides “…individual protection from catching colds or other viral infections when in a large crowd or in close contact with potentially infected individuals,” and that, “If you know that you are going to be in a large crowd, you can use Novid™ nasal spray prior to exposure and afterwards to provide some personal protection.” Such claims that suggest novid NASAL SPRAY protects and/or prevents consumers from getting sick are not permitted under M012. Furthermore, the labeling for novid NASAL SPRAY also includes additional intended use claims that are not permitted under M012, such as “The only nasal spray that is effective in reducing inflammation,” “Novid™ is formulated with a patented ingredient, Fulvic Gold, which enhances the immune-enhancing activity of the nasal spray,” and your product contains “…a safe and effective ingredient that augments our immune cellular activity.”

Therefore, your novid NASAL SPRAY drug product does not comply with the cold, cough monograph described above or any other final order.3 Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Thus, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Accordingly, this product is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Misbranded Drug Violations

Additionally, novid NASAL SPRAY is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product 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 violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any 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 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent by email to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance at FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

______________________

1 Your firm markets this product to contain the active ingredients sodium chloride and organic fulvic acids.

2 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330 prior to enactment of the CARES Act. In the case of OTC antihistamine and nasal decongestant drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. (See Order ID OTC000026, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)

3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that novid NASAL SPRAY is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.

 
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