Inspections, Compliance, Enforcement, and Criminal Investigations
Oasis Consumer Healthcare, LLC 2/11/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Silver Spring, MD 20993-0002|
February 11, 2013
Mr. Brian Sokol and Mr. Afif Ghannoum
Oasis Consumer Healthcare, LLC
812 Huron Rd., Suite 235
Cleveland, Ohio 44115
Dear Mr. Sokol and Mr. Ghannoum:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your firm's marketing of your product, Halo, on your website, www.halogermdefense.com. According to information on your website, Halo is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on your website that documents these intended uses include, but are not limited to, the following:
• "Whether you're in a minivan full of knee-high sneezers, or boarding a flight aboard Secondhand Air, you can rest assured that three quick sprays of Halo™ will keep you protected from airborne germs for up to six hours."
• "Protection From the Air You Share"
• "Available in the Cough & Cold Section"
• "Protects Against Airborne Germs Offices • Public Spaces • Travel"
• "Knowing that Halo has been proven to kill 99.9% of infectious germs, you'll be ready to embrace the sneezers and coughers in your life."
• "I've been using Halo for 9 months and feel like I've dodged everything coughed, breathed or recycled at me, even through a rough germ filled winter."
• "I work on a very large hospital campus and, therefore, am exposed to both office and hospital germs on a daily basis. Throughout the course of my day, I spend time with many different people in various areas across the campus, in offices as well as patient care areas. My exposure to airborne germs throughout the day is significant. Before using Halo, I felt susceptible, but now I have a sense of security because I know that Halo can protect me!"
In addition, claims on your Twitter page (available at https://mobile.twitter.com/halogermdefense) include the following:
• "Get your #flu vaccine & keep Halo handy to help prevent the flu this season ....."
• ''Getting on a plane, train or bus to get to your Thanksgiving destination? Bring along @HaloGermDefense! Protection from the #airyoushare."
Furthermore, the "about" section of your Facebook account (at https://www.facebook.com/HaloGermDefense/info) provides:
• "Just in time for back to school and the cough and cold season, Oasis Consumer Healthcare is making it safer to breathe the air you share for up to six hours with just three sprays with their new, unique Halo™ Oral Antiseptic. Halo is the first-ever, patent-pending, oral antiseptic spray that has been scientifically proven to kill 99.9% of infectious germs, including a broad spectrum of bacteria and viruses, such as rhinovirus (the virus that causes the common cold), influenza, strep, whooping cough (Bordetella pertussis), and H1N1."
Your January 15, 2013, PR Newswire press release entitled, "Strong Flu Season Grips the Nation, Leaving Americans Scrambling for Solutions to Protect Their Families," also demonstrates the intended use of your product.
Accordingly, Halo is a drug, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man or other animals.
We note, although your product includes a Drug Facts panel with information that corresponds to conditions proposed under the Over-the-Counter (OTC) Human Use Tentative Final Monograph (TFM) for Oral Antiseptic Drug Products (59 FR 6084, Feb. 9, 1994), your product is marketed for intended uses that are not addressed under this rulemaking or any other rulemaking under the OTC Drug Review. Oral antiseptics are applied topically to the oral cavity to help prevent infection in wounds caused by cuts, scrapes, or injury following minor dental procedures. Your product's intended use under the Drug Facts Panel is as a "[f[irst aid to help prevent infection in minor oral irritations." However, as indicated by the intended uses cited above, your product labeling includes claims that are well beyond the uses covered under the TFM for Oral Antiseptic Drug Products.
Based on its labeled uses, Halo is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the 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 FDA-approved application is in effect for it. Your sale of Halo without an approved application violates these provisions of the Act.
Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use it safely for its intended uses. Thus, Halo labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).
* * *
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you and your firms comply with all requirements of federal law and FDA regulations. Please note that FDA may contact distributors listed on www.halogermdefense.com and provide a copy of this letter.
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. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Address your reply to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Attention: Sarah Burrell.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration