Brief of US FDA Warning Letters

CDER - Mar 2023 II

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-
investigations/compliance-actions-and-activities/warning-letters

Compiled and Presented by

Tamer Helmy, PhD
Bio-Pharma Quality - Tech Ops – CMC

LinkedIn: https://www.linkedin.com/in/tamer-helmy
 Brief of the FDA CDER Warning Letters

Posted Letter
Company Name Subject Excerpt
Date Issue Date

… RE: WL 2496 Dear Ms. Burke: The United States Food and DrugAdministration
(FDA) has reviewed your firm’s drug … electronic DrugRegistration and Listing
Procter & Gamble
System (eDRLS) for your drug product, Vicks Nyquil Severe Hot Remedy Cold …
3/21/23 3/14/23 Manufactura S. de R.L. de Failure to Register and List
should be sent to U.S.
C.V.
Food and Drug Administration, Center for Drug Evaluationand Research/Office of
…

… www.ivermectin4covid.com … FROM: The United States

Notice of Unlawful Sale of
Food and DrugAdministration RE: Notice of Unlawful Sale of Unapproved … FDA
www.ivermectin4covid.c Unapproved Drugs to United
3/21/23 3/16/23 has observed that your website offers drug products forsale in the U.S. that are
om States Consumers Over the
intended to mitigate, prevent, … Security, Integrity, and Response Office of
Internet
Compliance Center for Drug Evaluationand Research …
Company /
Producer Procter & Gamble Manufactura S. de R.L. de C.V. - 1
Subject Failure to Register and List

Observation The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and
Listing System (eDRLS) for your drug product, Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, NDC 58933-541. Our review determined that
your firm has submitted contradictory information between the labeling and the electronic listing file. As such, your firm is in violation of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as explained below.
Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug
products. In the case of, Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, NDC 58933-541, the listing includes mismatched list of active
ingredients between the labeling and the electronic listing file (SPL) as outlined below:
The listing file for Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, NDC 58933-541, must include the name and quantity of each active
pharmaceutical ingredient as required under section 510 j(1)(C) and 21 CFR 207.49(a)(4). In the listing file submitted for Vicks Nyquil Severe Hot Remedy Cold
and Flu Plus Congestion, NDC 58933-541, the active ingredients included in the labeling do not match the active ingredients included in the electronic listing
file in Structured Product Labeling (SPL) format.

Products Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion

Violation Firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, and the failure to provide any informati on required by section 510(j) is a
prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a dru g with FDA also renders it
misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 331 (a).

Action In your response to this letter: Please notify this office in writing within 15 working days of receipt of this letter describing the specific steps you have taken
or will take to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence
of any violations.
Company /
Producer www.ivermectin4covid.com
Subject Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

Observation The FDA has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation o f sections 301(a), 301(d), and
505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), and 355(a)].

Products Ivermectin marketed as “Iverheal 12mg” manufactured by Healing Pharma

Details of the www.ivermectin4covid.com offers ivermectin marketed as “Iverheal 12mg” manufactured by Healing Pharma. Your website states, “Ivermectin (Iverheal 12) is an
antiparasitic, and also an antiviral drug manufactured by Healing Pharma. It is used to kill the parasites in the body. It is also useful in Covid 19 care.” While there
Violation are FDA-approved versions of ivermectin on the market in the U.S., there are no approved drug applications pursuant to section 5 05 of the FD&C Act in effect for
the “Iverheal 12mg ” manufactured by Healing Pharma and offered by www.ivermectin4covid.com. FDA-approved ivermectin tablets are approved for the
treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis and onchocerciasis due to the nematode
parasite Onchocerca volvulus, and are only available by prescription. In addition, ivermectin has not been approved by FDA for use in the prevent ion, diagnosis,
treatment, mitigation, or cure of COVID-19.
Misbranded Drugs:
Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate
directions cannot be written such that a layperson can use the products safely for the intended uses. Consequently, the label ing for these drugs fails to bear
adequate directions for use, causing them to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because the drugs are not approved in the U.S.,
they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act.

Action In your response to this letter, provide:

• We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you are not misleadingly
representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing
misbranded products in violation of the FD&C Act.