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performance-related "research chemicals"

The ‘research chemical’ path to market for illegal sports, sex and diet ingredients

Unscrupulous supplement-related companies sell illegal drugs under the guise of “for research only” disclaimers with scant government oversight.

NEWS ANALYSIS

If your end consumers masquerade as researchers and your merchandise, sales and marketing operate under a disclaimer that the finished products are “for research purposes only” and “not fit for human consumption,” can you sell just about anything you want, including illegal performance-enhancing ingredients?

Many online-only companies think so, including those who also sell non-drug sports and dietary supplements.

This seems like an obvious rouse when sports and anabolic forums linked to such sales websites have customers seeking advice for a 200+ lb. “female bunny” who is taking SARMs (selective androgen receptor modulators), a “guinea who needs to drop 20 [lbs.]” or switching from the SARMs ostarine and ligandrol to candarine for a “monkey rat squirrel.”

It is a wink-wink tactic FDA is aware of and has acted on in some cases. But not enough for these companies to stop selling illegal “research chemicals.”

In January 2019, the Department of Justice (DOJ) announced Keith Kovaleski and Ines Maltez were arrested for a “research chemical” scheme to market and distribute misbranded drugs online as All American Peptide (aka AA Peptide LLC). The criminal complaint, developed in conjunction with FDA’s Office of Criminal Investigations (OCI), alleged the pair knowingly sold sports, diet and sex drugs to bodybuilders and other consumers engaged in weight control and performance.

“The AAP [All American Peptide] website included a bogus legal disclaimer that its products were intended for laboratory research use only, and not as drugs or food,” DOJ said in a press release. “Kovaleski employed the bogus ‘research chemicals’ disclaimer to conceal that he and others were distributing misbranded drugs and unapproved new drugs for use by their customers.”

Kovaleski and his wife, Sylvia Kovaleski, were arrested in July 2019 on a 16-count indictment related to the sale of bogus “research only” drugs to bodybuilders and other consumers via the AAP website. 

The U.S. Attorney's Office, District of New Jersey, confirmed via email this is one case, with Maltez charged by complaint and the Kovaleskis charged by Indictment. 

“The Kovaleskis, through AAP, sold products including: (1) prescription drugs, such as tadalafil, the active ingredient in Cialis; (2) SARMS, used by body-builders as an alternative to steroids; (3) peptides, also used as performance-enhancing substances; and (4) other drugs that were not peptides or SARMS, and had not been approved for human use, for example, clenbuterol, a drug sold in foreign markets but not approved by the FDA,” DOJ reported.

According to the indictment, the Kovaleskis used their basement in Perth Amboy, New Jersey, to manufacture and label the products, including homemade capsules containing baking soda and the sex drug tadalafil. They made at least US$2.5 million via this basement enterprise, according to the prosecution.

The Kovaleskis each face maximum prison time of 50 years and maximum per-charge fines of $250,000  ($4.0 million total) or twice the gross gains from the illegal activities.

Patchwork of regulations dictating research chemical sales

There are regulations (21 CFR 1301.13, 1301.18 and 1304.22) and registration and recordkeeping requirements for any entity manufacturing, distributing, dispensing, researching, importing and handling controlled substances, which would include steroids, but not SARMs and tadalafil.

All distribution for research of controlled substances requires registration with the Drug Enforcement Administration (DEA), said a DOJ spokesperson, via email.

In addition to registration, the authorized party must have an approved protocol (evaluated by the Department of Health and Human Services (HHS)/FDA for scientific merit), and all distribution/procurement details must be preapproved through the application process, the spokesperson stated. 

“This means that the distributor must include all details of who they will be distributing to and what substances (there are separate application processes for Schedule I and Schedule II-V research), and likewise, the researcher must include details of what substances they will be researching and from where they will be procuring those substances (this would require the distributor and researcher to coordinate in advance of application),” she explained. “Any changes to distribution/procurement (amounts, sources, etc.), would require notification to and approval from DEA.”

For other "research chemicals," sales fall under existing rules for drugs, foods and supplements. In the case of the Kovaleskis, the indictment alleged AAP violated the Food, Drug and Cosmetic Act (FD&C), which regulates prescription drugs sales, as well as sales of new drugs requiring new drug application (NDA) or investigational new drug application (IND) approval.

However, unlike for controlled substances, there is no pre-registration process required for selling non-controlled “research chemicals” to legitimate research entities. Thus, FDA can’t just prove lack of registration, authorization or recordkeeping, but they must show the vendor violated FDCA by selling unapproved or new drugs to consumers for human consumption.

At press time, FDA had not issued a comment per INSIDER's request.

Online ‘research chemical’ sales a true Wild West

In the absence of serious federal enforcement action, companies are marketing and selling prescription and new drugs to regular consumers, who have no guarantee what is in the products.

A November 2017 JAMA publication reported only 23 of 44 products labeled as SARMs and sourced online from “research only” websites contained one or more SARMs such as ostarine, ligandrol or andarine (JAMA. 2017 Nov 28;318(20):2004-2010).

The study, a collaboration between Harvard Medical School, the U.S. Anti-Doping Agency (USADA) and the U.S. military, further found 17 of the products contained an unapproved drug, including the growth hormone secretagogue ibutamoren, the peroxisome proliferator-activated receptor-delta agonist GW501516 (aka cardarine), and the Rev-ErbA agonist SR9009 (aka stenabolic). Only 18 products had the labeled amount of active, and four products had no active ingredient.

“These findings suggest the need for greater regulatory oversight of products sold on the internet,” the researchers concluded.

The Kovaleski case is not the first time FDA and DOJ have encountered illegal sports, diet and sex ingredients being sold under the guise of being “for research purposes only.”

In December 2017, FDA raided the Sacramento facilities of Enhanced Athlete, seizing SARMs and other items. Enhanced Athlete sold SARMs as “research only” products on the same website they sold sports supplements.

Enhanced Athlete’s European division, based in England, was convicted in UK court in February 2019 for selling DNP.

In the United States, Enhanced Athlete’s CEO Scott Cavell was arrested on probation violations in early 2017 and  sentenced to three years in May 2019 for selling the fertilizer DNP as a fat burner via a shell online company called Fertilizer Warehouse—Enhanced Athlete directed bodybuilding consumers to the fertilizer website to buy DNP.

In addition to Cavell, Enhanced Athlete was prominently associated with Anthony Hughes, aka Dr. Tony Huge, who was the face of the company on social media, including many videos documenting the use of SARMs and other drugs for body composition and performance enhancement.

Despite seizing SARMs and other materials from Enhanced Athlete and forging a plea agreement with Cavell over DNP and the probation violations, federal officials have not taken further enforcement action against the company for selling bogus research chemicals.

A federal investigation against Cavell and Enhanced Athlete for the SARMs sales was revealed in documents from a competitor lawsuit against Enhanced Athlete in 2018, but there has not yet been an indictment or criminal complaint filed by the government.

The lawsuit was filed by Nutrition Distribution against Enhanced Athlete in the absence of federal enforcement of illegal SARMs sales.

In a declaration for the lawsuit, Cavell’s attorney, Ron Peters, said, “[The federal prosecutor] informed me that Mr. Cavell is a subject of a criminal investigation involving Enhanced Athlete and its sale of supplement products including [SARMs].”

Enhanced Athlete and AAP are only two of many such companies selling sports, diet and sex drugs via this "research chemical" method. Many brazenly communicate online about these ingredients with bodybuilders and other non-research-affiliated consumers.

Newroids is run by Seth Williams, whose online presence is similar to that of Hughes, including numerous videos on his YouTube channel—YouTube has shut down several channels run by Hughes and Williams for violating terms, but they simply open new channels and/or, in the case of Hughes and Enhanced Athlete, move videos to another website.

Williams’ website, NewTriCare.com, sells “research chemicals” such as SARMs (ligandrol and andarine) and growth hormone-related substances (ibutamoren or Nutrabol), as well as other sports, sex and weight nutrition products. The website includes the “for research only” disclaimers but also features a Gains Report, which offers users “a full computerized tracking system of your gains!”

The FAQs on the Newroids website direct consumers to an Anabolic Anonymous Google forum for more information on dosing “for research.” The forum has threads on SARM science, usage and websites to buy them. Some posts slyly use terms like “my lab monkey rat squirrels” to give the appearance they are using the products for research.

At press time, Williams had not returned INSIDER's request for comment.

The many other websites selling SARMs, steroids and other drugs to U.S. and international consumers include Purple Panda Labs, Roids24 and Steroidify. Some are based overseas but sell to U.S. consumers. Likewise, there are many associated forums discussing anabolic products, dosage, usage, customer reviews and where to buy, such as Anabolic Steroid Forums, Anabolic Board and Fitness Geared.

 

 

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