Boiron, Inc.
2 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
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…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Optique 1 Eye Drops is an unapproved new drug marketed for eye irritation relief without an FDA-approved application.
Supporting FDA text
Source excerpt · automated text-match checkYour “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).
The product is labeled as homeopathic but is subject to the same statutory requirements as all drugs, including approval.
Supporting FDA text
Source excerpt · automated text-match checkWe 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.
Findings extracted from the letter
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Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- 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 cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.