SUPPLEMENTARY INFORMATION:

I. Background

Section 306(b)(1)(D) of the FD&C Act (permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On August 6, 2025, Mr. Thies was convicted as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for the Eastern District of Pennsylvania, when the court accepted his plea of guilty and entered judgment against him on two counts for the felony offenses of trafficking in counterfeit goods in violation of 18 U.S.C. 2320(a)(1) and aiding and abetting in violation of 18 U.S.C. 2. The underlying facts supporting the conviction are as follows:

As contained in the Indictment and in the Government's Change of Plea Memorandum, from in or around 2020 through in or around January 2023, Mr. Thies operated websites, including “ sexpillshop.com,” through which he trafficked counterfeit “sex pills.” In order to obtain and manufacture the counterfeit pills, Mr. Thies smuggled counterfeit Viagra and Cialis pills and packaging and the active ingredients sildenafil and tadalafil into the United States from foreign suppliers in China and India. Viagra and Cialis are prescription drug products that are approved by FDA for distribution within the United States for certain medical conditions. Under Federal law, and in order to ensure public health safety, genuine prescription drug products must be manufactured and distributed under strict quality control standards and may be dispensed only upon a doctor's prescription and by a licensed pharmacist.

On or about December 16, 2020, a federal agent acting in an undercover capacity visited a website controlled by Mr. Thies. The website advertised for sale a large number of pills listed as “male enhancement products,” which were available for purchase in various quantities and packages. The agent placed an order for two packs of “sex pills”: “80 Pill Steal Variety Pack” and “50 Pill All Imports Variety Pack.” The agent paid a total of $99.98 to an account controlled by Mr. Thies. Two days later, on December 18, 2020, the agent received an email from sexpillshop@gmail.com that confirmed the pills were shipped by U.S. mail, provided a tracking number, and offered a cell phone number registered to Mr. Thies for any additional assistance. When the agent sent a follow-up email, Mr. Thies responded and apologized for the delay.

On or about January 13, 2021, the agent received a parcel with his order of pill packs in an undercover mailbox. The parcel sent by Mr. Thies contained a variety of pills. Some pills were in unmarked blister packs; others were in capsules and packaging with names including “Superman,” “Black Mamba,” and “Blue Rhino.” Much of the wording on the packaging was in a foreign language. The parcel also included a blue and silver box labeled “U.S.A. Viagra” with a glass vial labeled “U.S.A. Viagra,” which contained 10 blue almond-shaped tablets imprinted with “USA” on each side. Law enforcement identified fingerprints on the parcel and its contents that matched Mr. Thies's fingerprints. The Viagra packaging and pills were counterfeit.

On January 11, 2023, law enforcement executed a federal search warrant at Mr. Thies's home in Philadelphia, Pennsylvania. In his residence, agents found a pill laboratory in the basement work area where Mr. Thies manufactured, packaged, and prepared to ship counterfeit pills to consumers. Agents seized his computers, phones, and other items consistent with the trafficking of counterfeit pills, such as pill bottles, pill presses, baking flour, various packages of male enhancement pills, other packaging and shipping materials, empty capsules, and counterfeit Viagra and Cialis pills. Most of these items were found on and ( printed page 60972) around a dirty, non-sterile bench area in the basement laboratory where multiple house cats also lingered. Specifically, agents seized from Mr. Thies's residence 90 tablets purporting to be Viagra and 90 tablets purporting to be Cialis. The Viagra and Cialis packaging and pills were counterfeit. The counterfeit marks and trade names, “Viagra” and “Cialis,” used by Mr. Thies were identical or substantially indistinguishable from the genuine marks owned by Pfizer, Inc./Viatris, Inc. and Eli Lilly & Company, and Mr. Thies used the marks in connection with purported “sex pills,” which were likely to confuse or deceive consumers into believing that the product was made by the genuine owner of the trademark. Mr. Thies was present at his residence at the time of the search.

During the search, Mr. Thies admitted to law enforcement that he sold male enhancement pills on his websites, including on sexpillshop.com, sometimes receiving up to three orders a day. On January 13, 2023, Mr. Thies met with law enforcement agents and again admitted that he sold male enhancement pills on his websites for years. He also stated he previously sold pills on eBay and social media platforms, but that his accounts were closed upon being told that he could not sell counterfeit products on those platforms.

Law enforcement searched and reviewed the email accounts Mr. Thies operated, including sexpillshop@gmail.com and jeffmetthies@gmail.com. These email accounts contained lengthy correspondence between Mr. Thies and foreign suppliers of male enhancement pills, ingredients, and packaging, including suppliers from China and India, and customers who purchased pills from his website. At times, Mr. Thies faced impediments to importing counterfeit pills and packaging from foreign countries. When his shipments were seized or took longer to arrive, Mr. Thies would direct his foreign suppliers to use different names and different shipping addresses, in order to disguise or conceal the destination of the shipments. In an email on April 28, 2021, for example, Mr. Thies told a supplier, “CHANGE IT TO [an alias name] AND MAKE IT APARTMENT #3 INSTEAD OF #1.” On June 7, 2021, Mr. Thies was made aware through an email from a global shipping company that his package had been detained by United States Customs and Border Protection. Mr. Thies responded by stating, “I have 2 options[,] contesting isn't one of them.” In other emails, Mr. Thies was told by foreign suppliers that they were disguising or concealing the contents of shipments to avoid policies that prohibited the sale of certain drugs. For example, Mr. Thies received an email from a Chinese supplier stating, “[s]ince Alibaba [a Chinese e-commerce marketplace] forbids the sale of sildenafil [the active ingredient in Viagra], we drafted the credit order under the name of NMN, and the real goods are sildenafil.” Mr. Thies sold over $90,000 worth of pills to consumers throughout the United States during the relevant time period.

FDA sent Mr. Thies, by certified mail, on June 8, 2026, a notice proposing to debar him for a 10-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Thies's felony convictions under Federal law for trafficking in counterfeit goods in violation of 18 U.S.C. 2320(a)(1) and aiding and abetting in violation of 18 U.S.C. 2 were for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Thies illegally smuggled and trafficked counterfeit prescription drug products into the United States. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C that the Agency considered applicable to Mr. Thies's offenses and concluded that the offenses warranted the imposition of a 10-year period of debarment, consisting of two 5-year debarment periods for each felony count to run consecutively.

The proposal informed Mr. Thies of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Thies received the proposal and notice of opportunity for a hearing on June 11, 2026. Mr. Thies failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Jeffrey Thies has been convicted of felonies under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offenses should be accorded a debarment period of 10 years, consisting of two consecutive 5-year debarment periods as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Thies is debarred for a period of 10 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Thies during his period of debarment is a prohibited act.

91 FR 60970