More pandemic profiteering that might violate regulations, and definitely isn’t ready for prime time.
A company is selling a health product claiming it as a covid prophylactic using the distinguished Harvard name as a stamp of approval and erroneously claiming proof it works with a preclinical mouse study. They are hyping it in the press as well as advertising it via social media, and reportedly by approaching public health advocacy and social groups online.
Except the study being used as proof of efficacy is a preclinical Influenza A mouse study conducted by people with equity in Akita Biosciences,[1] which owns the “Profi” brand of nasal spray that is already being marketed and sold as a prophylactic against “airborne germs”.[2] There’s a PR piece by BWH Communications in The Harvard Gazette that makes the extremely bold claim that this product “blocks, neutralizes viruses, bacteria” and “offered nearly 100% protection from respiratory infections by COVID-19, influenza, viruses, and pneumonia-causing bacteria” in the title of the advertorial. Another “opinion” piece published in MarketWatch states: “The spray has not gone through the cumbersome process of getting regulated as a medical treatment by the Food and Drug Administration and is instead being sold as a personal-care product. Researchers used a 3D-printed replica of a human nose to test the nasal spray’s efficacy.”[3] But can “personal care products” really be sold under the claim of preventing disease? According to the FDA page on cosmetic labeling: “if a product is marketed with claims for purposes such as treating or preventing disease, or affecting the structure or function of the body — including the skin — it’s a drug according to the law, and it must meet the requirements for drugs, even if it affects the appearance.”[4]
The claim to be “drug free” is because reportedly the study authors deliberately went hunting for some ingredient already deemed safe and regarded by the FDA as an inactive ingredient, by selecting “several mucoadhesive biopolymers from the FDA’s inactive ingredient and GRAS databases” according to Chemical & Engineering News. C&EN also quotes: “Aaron Glatt, an epidemiologist at Mount Sinai South Nassau who reviewed the paper independently” who said “Without any clinical data, it’s extremely difficult to assess how well this spray works,” and “I would be very concerned about anybody using this without any evidence in humans.”[5] In the The Harvard Gazette the product is described as “drug free” but they’re simultaneously describing its use AS A DRUG. According to the U.S. HHS NIH Toolkit for Patient-Focused Therapy Development Glossary: “Conventionally, a drug refers to a synthesized pharmaceutical molecule or compound intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”[6] And that’s certainly what the whole point of the claims of this product — the claim is that this product can prevent disease!
The U.S. FDA describes an inactive ingredient: “According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient.” A product with no active ingredients can’t possibly claim to do anything or else it would have to have at least one active ingredient, as described by the FDA: “According to 21 CFR 210.3(b)(7), an active ingredient is any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals.” This can only mean one thing, if a claim of efficacy is made for the prevention of viruses, then the product is being said to have an active ingredient — and that’s what a drug is.
I’m not sure you’re allowed to just say it’s an inactive ingredient, just because it’s ordinarily used in some other way, as the Code of Federal Regulations Title 21 Food and Drugs says: “201.117 Inactive ingredients. A harmless drug that is ordinarily used as an inactive ingredient, such as a coloring, emulsifier, excipient, flavoring, lubricant, preservative, or solvent, in the preparation of other drugs shall be exempt from section 502(f)(1) of the act. This exemption shall not apply to any substance intended for a use which results in the preparation of a new drug, unless an approved new-drug application provides for such use.” And this certainly seems applicable when talking about a new product, with a new use for the ingredient — the claim of it being used as a disease preventative. The Code also says: “The Department of Health and Human Services is of the opinion that inert glandular materials may not be exempted from the requirements of section 502(f)(1) of the act that they bear adequate directions for use; and, accordingly, that their labeling must include among other things, representations as to the conditions for which such articles are intended to be used or as to the structure or function of the human body that they are intended to affect. Since any such representations offering these articles for use as drugs would be false or misleading, such articles will be considered to be misbranded if they are distributed for use as drugs.”[7]
It appears the assertion here is that mucoadhesive biopolymers are a drug delivery system,[8] therefore considered “inactive ingredients” and they’ve made a product with just the drug delivery system but not the drug. Except it becomes a drug, with an active ingredient, the moment you say that the ingredient is what is working and is intended for use in the prevention of a disease. The FDA states that the purpose of that “Inactive Ingredient Database” is simply for not having to reinvent the wheel in the drug approval process next time it’s used in a drug as an inactive ingredient: “if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.” And I don’t know if it’s being used in a similar manner since it’s now the active ingredient, and asserted to be the drug itself. And it’s a drug, because a health claim is being made — the prevention of disease. Even if they claimed it was a supplement instead of a personal care product, the claim is still a health claim. According to the Code of Federal Regulations Title 21 Food and Drugs: “Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including ‘‘third party’’ references, written statements (e.g., a brand name including a term such as ‘‘heart’’), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition.”[9]
The Code of Federal Regulations Title 21 Food and Drugs inclusion of “including ‘‘third party’’ references” suggests that if the claims are made by related parties, even if it’s not on the label of the product, it’s still a health claim. The Harvard Gazette PR release and the Marketwatch opinion piece could count as third party reference, even if they’re not making these specific disease claims or references on the product brand Profi website, which merely makes claims of “defense against airborne germs”. And even that doesn’t appear to be an end run around the health claim issue because the EPA has already established way back in 2005 that: “The use of the “germs” term over time has come to be commonly associated with disease-causing organisms, including ones caused by bacteria, viruses or fungi. As a result, the Agency considers the term “germs” to be a public health claim which must be supported by appropriate efficacy data.” So it really doesn’t matter if they say “germs” or “viruses” — they’re making health claims about disease.[10]
They use personal testimonials of healthcare professional customers to promote the product on the website, with their credentials listed. And there are many instances of personal testimonials seeded throughout forums and social media, such as Reddit, where Profi as a company appears to have a dedicated account active in pandemic-concerned subreddits,[11] as well as having posted a product unrelated thread in the r/Parenting subreddit, with the company account name.[12] Was it an accidental post by someone who forgot to sign out of the company account before posting on Reddit? If so, why didn’t they delete the post once they realized it. Or was it a deliberate attempt to advertise the product to parents who might buy it to use on their kids? I’ve seen multiple accounts in discord forums where desperate parents have been using these nasal sprays with prophylactic claims, some purchased on the internet from foreign countries with wire transfers, and giving it to the kids 4 to 5 times a day and asking about the safety of this because their kids are getting sore throats or nose bleeds. I’ve also heard of people getting bounced and banned from Facebook groups for warning that this might not be safe, or even just that they’re not approved by the FDA.
I have also heard that the company has reached out for partnership of some type with covid influencers or precaution organizations. I’m not sure what guidance those people and organizations are given, but they would be responsible for adhering to the FTC which states that: “Marketers of dietary supplements and other health-related products should ensure that anyone participating in marketing is familiar with basic FTC advertising principles.” and “The FDA has primary responsibility for claims that appear in labeling, including the package, product inserts, and other promotional materials available at point of sale. The FTC has primary responsibility for claims in all forms of advertising.”[13]
I don’t see how a personal care product could reasonably be said to prevent disease, and how they could say it’s drug free when what they’re describing is a product that absolutely fits the objective definition of a drug. It sure seems like someone should be verifying that this product is or is not a drug, and if it is or is not in compliance with regulations of the FDA and FTC. Personally I think it’s wrong to just say anyone can circumvent safety regulations just by claiming something’s not what it obviously is being sold as.
I think it’s problematic to assertively and enthusiastically publish PR to promote a product with such medical claims based on a preclinical mouse study.
References:
[1] Toward a Radically Simple Multi-Modal Nasal Spray for Preventing Respiratory Infections — John Joseph, Helna Mary Baby, Joselyn Rojas Quintero, Devin Kenney, Yohannes A Mebratu, Eshant Bhatia, Purna Shah, Kabir Swain, Dongtak Lee, Shahdeep Kaur, Xiang-Ling Li, John Mwangi, Olivia Snapper, Remya Nair, Eli Agus, Sruthi Ranganathan, Julian Kage, Jingjing Gao, James N Luo, Anthony Yu, Dongsung Park, Florian Douam, Yohannes Tesfaigzi, Jeffrey M Karp, Nitin Joshi https://doi.org/10.1002/adma.202406348
[2] Profi Nasal Spray — Defend Against Airborne Germs https://www.profispray.com/
[3] MarketWatch — Opinion: Harvard scientists say this $25 nasal spray beats flu, colds and COVID-19 with 99% success. This drug-free nasal spray could be a game changer if it lives up to the hype. By Brett Arends Last Updated: Sept. 28, 2024 at 9:59 a.m. ET First Published: Sept. 27, 2024 at 11:39 a.m. ET https://www.marketwatch.com/story/harvard-scientists-say-this-25-nasal-spray-beats-flu-colds-and-covid-19-with-99-success-b63cf1ae
[4] U.S. FDA — Cosmetics Labeling Claims https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-claims
[5] C&EN (Chemical & Engineering News) The biopolymers behind a multimodal nasal spray Profi aims to stop infections without drugs, but without clinical trials, questions remain https://cen.acs.org/materials/biomaterials/biopolymers-behind-multimodal-nasal-spray/102/i30
[6] U.S. HHS NIH Toolkit for Patient-Focused Therapy Development Glossary: Drug https://toolkit.ncats.nih.gov/glossary/drug/
[7] Code of Federal Regulations Title 21 Food and Drugs Parts 100 to 169 Revised as of April 1, 2024 Containing a codification of documents of general applicability and future effect As of April 1, 2024 Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register Volume 4 https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol4/pdf/CFR-2024-title21-vol4.pdf
[8] Recent advances in biopolymer-based mucoadhesive drug delivery systems for oral application Author: Rishav Sharma,Suraj Kumar,Rishabha Malviya,Bhupendra G. Prajapati,Dinesh Puri,Sontaya Limmatvapirat,Pornsak Sriamornsak Publication: Journal of Drug Delivery Science and Technology Publisher: Elsevier Date: January 2024 https://doi.org/10.1016/j.jddst.2023.105227
[9] Code of Federal Regulations Title 21 Food and Drugs Parts 100 to 169 Revised as of April 1, 2024 Containing a codification of documents of general applicability and future effect As of April 1, 2024 Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register Volume 2 https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol2/pdf/CFR-2024-title21-vol2.pdf
[10] U.S. Environmental Protection Agency — Use of the Term “Germs” on Antimicrobial Labels The following letter, sent from EPA to the Consumer Specialty Products Association, describes EPA’s policy on the use of the term “germs” on antimicrobial pesticide product labels. January 5, 2005 https://www.epa.gov/pesticide-labels/use-term-germs-antimicrobial-labels
[11] Reddit — Profi_Nasal_Spray u/Profi_Nasal_Spray https://www.reddit.com/user/Profi_Nasal_Spray/
[12] r/Parenting • April 11, 2024 Profi_Nasal_Spray Help! My Kids Have Alexa Wrapped Around Their Little Fingers https://www.reddit.com/r/Parenting/comments/1c1koc8/help_my_kids_have_alexa_wrapped_around_their/
[13] Federal Trade Commission — Health Products Compliance Guidance https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance