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WARNING LETTER

September 11, 2023

Boiron SA
2 Avenue de l’Ouest Lyonnais
Messimy, Rhone
France
infos@boiron.fr

RE: 663402

Dear Janick Boudazin:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.boironusa.com/ in July 2023. We also reviewed your social media websites at https://www.facebook.com/BoironUSA and https://www.instagram.com/boironusa/, where you direct consumers to your website, https://www.boironusa.com/, to purchase your product. The FDA has observed that your websites offer “Optique 1 Eye Drops” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U. S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your unapproved “Optique 1 Eye Drops” drug product is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

Based on a review of your websites, your “Optique 1 Eye Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your website, https://www.boironusa.com/ your social medial websites https://www.facebook.com/BoironUSA and https://www.instagram.com/boironusa/ that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

From the website https://www.boironusa.com/product/optique-1-eye-drops/:
• “EYE IRRITATION RELIEF”
• “Dry Eyes ● Allergies ● Eyestrain”
• “Boiron Optique 1 relieves minor eye irritation due to airborne irritants, such as dust, ragweed, and other pollens.* These homeopathic eye drops also refresh fatigued eyes from long hours at a computer.*”
• “Benefits and Features:
      Soothes red, dry, itchy, gritty, burning or tired eyes.*”
• “Temporarily relieves minor eye irritation such as dry, red, itchy, and burning eyes due to:
     eyestrain and fatigue
     light and glare
     digital displays
     airborne irritants (pollens and dust)”

From your Facebook and Instagram social media websites https://www.facebook.com/BoironUSA and https://www.instagram.com/boironusa/:
• On your May 11, 2020, posts: “Optique 1 relieves minor eye irritation due to airborne irritants, such as dust, ragweed, and other pollens. . . . refresh eyes that are tired and overworked from long hours at a computer.”
• On your October 8, 2020, posts: “Optique 1 Eye Drops relieve itchy, red, dry, tired, or burning eyes from allergies, computer eyestrain, and sensitivity to light and glare. . . . soothing relief for sore eyes.
• On your June 12, 2023, post: “Struggling with dry, irritated eyes? If you're on the East Coast, the current poor air quality could be the culprit. Optique 1 eye drops offer soothing relief for red, dry or itchy eyes triggered by airborne irritants.”

Your “Optique 1 Eye Drops” product is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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 sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Optique 1 Eye Drops.” Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

We recognize that your “Optique 1 Eye Drops” product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your product. 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. In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination. For more information about detention without physical examination, see Import Alert 66-41.

Please notify FDA in writing, within fifteen 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 fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration