WARNING LETTER
CVS Health
MARCS-CMS 663246 —
September 11, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Karen S. Lynch
Recipient Title
President & CEO
CVS Health
One CVS Drive
Woonsocket
,
RI
02895
United States
Karen.Lynch@cvshealth.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
September 11, 2023
RE: 663246
Dear Karen S. Lynch:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.cvs.com in July 2023. The FDA has observed that your website offers “CVS Health Pink Eye Relief 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 “CVS Health Pink Eye Relief Drops” 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.
1
Based on a review of your product labeling, including on your website, your “CVS Health Pink Eye Relief Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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 product labeling, including on your website www.cvs.com, that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:
On the product webpage for “CVS Health Pink Eye Relief Drops,” https://www.cvs.com/shop/cvs-health-pink-eye-relief-drops-0-33-oz-prodid-1010883:
"Relieves •Redness •Burning •Watery discharge •Gritty sensation”
“[T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”
“CVS Health Pink Eye Drops is a homeopathic formula that stimulates the body’s ability to relieve redness, burning, watery discharge, and sensations of grittiness.”
“When your eyes are dry, itching, or burning, it can be a big problem that you want relief from right away. These Irritated Eye Drops from CVS Health can provide you with the rapid relief you need . . . They are very helpful for relieving irritation, redness, burning, and dryness. The homeopathic formula is safe for use in the eyes and easy to apply . . . These drops are gentle enough for frequent use and even for use on children.”
Your “CVS Health Pink Eye Relief Drops” 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 “CVS Health Pink Eye Relief 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 “CVS Health Pink Eye Relief Drops” 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.
Additionally, CVS is responsible for ensuring that the drug products it distributes are not adulterated. We understand that your “CVS Health Pink Eye Relief Drops” product is produced for CVS by a contract manufacturer, i.e.,
(b)(4)
. The significant violations of Current Good Manufacturing Practice (CGMP) requirements observed at
(b)(4)
, with respect to its manufacture of homeopathic ophthalmic products, are documented in the Agency’s
(b)(4)
warning letter to
(b)(4)
. Under section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), drugs are deemed adulterated if they are not manufactured in conformance with CGMPs. The CGMP violations identified at
(b)(4)
caused all drug products manufactured by
(b)(4)
to be adulterated. The introduction, delivery for introduction, or causing the introduction or delivery for introduction into interstate commerce of an adulterated drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Further, the receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c).
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 product is 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
cc:
(b)(4)
___________________________
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We note that your ophthalmic drug products utilize silver sulfate as a preservative. The Agency has significant concerns regarding the safety of silver sulfate for use as an ophthalmic preservative. Long term use of medicinal compounds containing silver may cause argyria, which is a blueish-gray discoloration of the skin and eyes that is irreversible. Additionally, granular deposits of silver in the conjunctiva and cornea may cause decreased night vision. Accordingly, we are concerned that your use of silver sulfate as a preservative in your ophthalmic products is inconsistent with 21 C.F.R. 200.50(b)(1), under which ophthalmic preservatives should be “suitable and harmless.”
Content current as of:
09/12/2023
Regulated Product(s)
Drugs