'Herbal Supplement' Marketer Faces Prison For Distributing Unapproved Drugs

Following FDA investigation, Kansas businessman Rick Shepard was indicted on charges of conspiracy and introducing misbranded drugs into interstate commerce.  In addition to purchasing the drugs from a supplier in China, indictment alleged he had the drugs in packages were labeled “healthy food samples” delivered to private shipping and mailing stores throughout the country.

Voluntarily recalling a drug-spiked product marketed as an herbal supplement didn’t keep a Kansas businessman from facing criminal charges that could result in time in prison.

Rick Shepard was operating Epic Products LLC in Overland Park and selling to “adult novelty stores” in Kansas, Missouri and Colorado products branded Euphoric Premium Male Performance Enhancer as an “all natural herbal supplements” when the Food and Drug Administration’s in 2018 found the products were spiked with undeclared sildenafil, tadalafil and oxytetracycline drug ingredients, according to the US Attorney’s Office for the District of Kansas.

Shepard on 27 January pleaded guilty in US District Court in Kansas City to importing and selling misbranded pharmaceutical-grade erectile dysfunction drugs from China and marketing them as herbal remedies. When sentenced on for April 20, Shepard could face up to five years in federal prison and a fine of up to $250,000.

Following an FDA investigation, a federal grand jury in March 2019 indicted Shepard on one count each of conspiracy and introducing misbranded drugs into interstate commerce. In addition to purchasing the drugs from a supplier in China, the indictment alleged he had the drugs delivered to private shipping and mailing stores throughout the country before the packages, which were labeled “healthy food samples,” were forwarded to him in Kansas, where he repackaged the capsules, applied his own labels and distributed them.

The first action after the FDA determined Shepard’s supplements products were spiked, though, was to ask him in April 2018 to recall the products. As a sign of the agency’s urgency, it added to its recalls database information that Epic Products was recalling its products without, as it does with the large majority of recalls, first assigning the recall a number or classifying the action. (Also see "Health, Beauty And Wellness News: UK Weight Loss Ad Claim, US GMP Warning, Recalls " - HBW Insight, 22 Nov, 2018.)

Epic Products operator was accused of having drugs delivered to private shipping and mailing stores throughout the country before the packages, which were labeled “healthy food samples,” were forwarded to him in Kansas, where he repackaged the capsules, applied his own labels and distributed them.

Additionally, the FDA at that time published a consumer alert about the products, including a statement that a voluntary recall was underway. It also added Epic Products to its “2018 Recalls - Health Fraud” list, which includes this statement:

“The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.”

Shepard’s conviction is the latest on criminal charges that followed Department of Justice reaction to an FDA investigation of manufacturing or marketing drug-spiked supplements. However, previous charges that DoJ has prosecuted from FDA investigations in the supplement marketplace targeted larger businesses and multiple defendants. (Also see "Federal Sweep Nets 40 Criminal, Civil Cases For Spiked Supplements, Disease Claims" - HBW Insight, 23 Nov, 2015.)

Still, industry stakeholders long have encouraged the FDA to seek more criminal charges against people and businesses linked to products marketed as supplements but containing undeclared drugs. Convictions on criminal charges, with the potential for prison sentences as well as fines, are a stronger deterrent against further sales of drug-spiked supplements than allowing the offended parties firms to recall the products and potentially incur financial penalties from civil complaints filed by the DoJ. (Also see "DoJ Prosecutions: USPlabs Guilty, DMBA Firm Indicted From FDA Investigations" - HBW Insight, 14 Mar, 2019.)

The FDA’s investigations of marketers of drug-spiked supplements frequently begin after agency officials find the ingredients in personal mail packages, such as those Shepard received, that enter the US through its nine international mail facilities.

The FDA commissioner's office told HBW Insight that in fiscal year 2019, across all the IMF facilities, the agency screened around 25,200 parcels containing more than 41,000 products. Officials detained more than 38,000 of the products, including 1,801 identified as dietary supplements, and the agency expected to destroy more than 17,000 subject to its administrative destruction authority. (Also see "FDA Using Ion Mobility Spectrometers In 4 IMFs, Plans Use In 4 More" - HBW Insight, 16 Oct, 2019.)