WARNING LETTER
Walgreens Boots Alliance, Inc.
MARCS-CMS 663404 —
September 11, 2023
Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Stefano Pessina
Recipient Title
Executive Chairman
Walgreens Boots Alliance, Inc.
108 Wilmot Rd., MS# 2002
Deerfield
,
IL
60015
United States
Stefano.Pessina@walgreens.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
September 11, 2023
RE: 663404
Dear Stefano Pessina:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.walgreens.com in August 2023. The FDA has observed that your website offers “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” for sale in the United States. Based on our review, these products are unapproved new drugs 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 these products 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 “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” products are 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 “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” are drugs 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.walgreens.com, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
Walgreens Allergy Eye Drops
From the webpage www.walgreens.com/store/c/walgreens-allergy-eye-drops/ID=prod6384859-product:
• “For relief of itching, burning, watering & redness of eyes”
• “[T]emporarily relieve minor eye allergy symptoms such as: itching burning excessive watering redness of eyes and lids”
Walgreens Stye Eye Drops
From the webpage www.walgreens.com/store/c/walgreens-stye-eye-drops/ID=400394228-product:
• “Multi-symptom relief of redness, burning & tearing”
• “The purpose of this product is to provide temporary relief of stye symptoms”
• “[T]emporarily relieve minor symptoms such as: •redness •burning •eyelid redness •tearing”
• “[T]emporarily relieve minor symptoms associate with styes, such as: redness burning dryness tearing”
Walgreens Pink Eye Drops
From the webpage https://www.walgreens.com/store/c/walgreens-pink-eye-drops/ID=prod6124299-product:
• “Relieves redness, burning, watery discharge & sensation of grittiness”
• “For irritation, dryness, and burning”
• “[T]emporarily relieve minor eye symptoms: •excessive watery (clear) discharge •sensation of grittiness •redness and burning”
Your “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” 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 “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops.” Accordingly, the introduction or delivery for introduction into interstate commerce of these products 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 “Walgreens Allergy Eye Drops,” “Walgreens Stye Eye Drops,” and “Walgreens Pink Eye Drops” are labeled as homeopathic drugs 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, Walgreens is responsible for ensuring that the drug products it distributes are not adulterated. We understand that your above-listed products are produced for Walgreens 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 CGMP. 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 products. 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
cc:
(b)(4)
(b)(4)
______________________
1
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