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# CDER Compliance Targets 3 Enforcement Areas
- URL: https://www.fdaweb.com/cder-compliance-targets-3-enforcement-areas/
- Published: 2021-10-14T12:00:00.000Z
- Updated: 2026-09-14T17:19:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150371

CDER’s Office of Compliance has been targeting three enforcement areas in drug advertising and promotion — fraudulent Covid-19 products, products containing hidden drug ingredients, and illegally marketed opioid products. Speaking at an enforcement update at the Food and Drug Law Institute’s annual advertising and promotion conference 10/13, CDER Office of Compliance director **Don Ashley** said that during the Covid pandemic the Center has issued more than 120 Warning Letters to firms because their illegally marketed products claimed they could treat Covid-19\. Additionally, more than 15 Warning Letters have been issued to internet pharmacies that were selling unapproved drugs for Covid-19.

One of CDER’s recent concerns, according to Ashley, is a growing trend in anti-vaccination circles that gargling povidone iodine or adding it to a nasal spray can prevent or treat Covid-19\. Povidone iodine is a water based antiseptic that's covered by a tentative final monograph as an OTC topical antiseptic. “However, there’s no data to demonstrate that povidone iodine is effective for the treatment or prevention of Covid-19,” he said.

Ashley highlighted a July Warning Letter to Halodine (Miami, FL) after discovering the firm marketing povidone iodine. The [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/halodine-llc-611150-07072021?ref=fdaweb.com) told the firm to take immediate action to correct the violations cited in the letter and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation.

Regarding products containing hidden drug ingredients that are often marketed for sexual enhancement, weight loss, and bodybuilding, and found at convenience stores, Web sites and on online marketplaces (Amazon and eBay), Ashley pointed to an [untitled letter](https://www.fda.gov/media/151096/download?ref=fdaweb.com) sent to Amazon in July telling the firm it needs to better police products containing hidden drug ingredients.

Joining Ashley in the enforcement update was Justice Department Consumer Protection Branch (CPB) assistant director **John Claud** who discussed several recent cases that were referred by FDA for prosecution. He said a new initiative between FDA and CPB has focused on clinical trial fraud. For example, a [case earlier this year](https://www.justice.gov/opa/pr/medical-doctor-and-study-coordinator-sentenced-prison-scheme-falsify-clinical-trial-data?ref=fdaweb.com) saw a Florida medical doctor sentenced to 63 months in prison after pleading guilty to her role in a scheme to falsify clinical trial data regarding an asthma drug. The doctor was the primary investigator at Unlimited Medical Research in Miami. The doctor and site director admitted that they participated in a scheme to defraud an unnamed pharmaceutical company by fabricating data and participation of subjects in a clinical trial, the government contended.

In another [recent case](https://www.justice.gov/opa/pr/doctor-clinic-owner-and-staff-charged-falsifying-clinical-trial-data?ref=fdaweb.com) involving Tellus Clinical Research, a sub-investigator and assistant study coordinator admitted that they conspired with others to falsify data in connection with two clinical trials, according to Claud. They allegedly fabricated medical records to make it appear as though trial subjects were participating in the clinical trials when they were not, he said.

Claud said the clinical trial fraud initiative is a big project for CPB and “we've got a lot of our folks working on these cases.” In fact, he said CPB is growing from 75 prosecutors to 100 by the end of the year due to increased referrals from FDA, FTC and other government clients.