Power Report: Shady US supplement gets green light for SA sales

The 35-page indictment reads like a movie script. Dodgy drug imports, conspiracy and fraud. Throw in sick consumers, money laundering and luxury sports cars and you have the makings of a Hollywood blockbuster.

But none of it is make-believe. Central to the drama are two bestselling dietary supplements made in the US, one of which is still on the shelves in South Africa. The other, thankfully, was pulled two years ago.

Last week, popular pre-workout supplement Jack3d was removed from Dis-Chem shelves, tested negative for a banned substance, and promptly returned to stores this week.

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In light of the US Department of Justice indictment, the decision by South Africa's second-largest chemist retail chain to continue selling the product surprises me. Here's why:

At least four executives of the company that makes Jack3d have been arrested in the US, accused of having sold so-called "natural" workout and weight-loss supplements that were actually laced with synthetic chemicals from China.

Authorities also claim the executives, including the CEO, sold products without determining their safety.

"Instead of legitimate COAs [certificates of analysis] that accurately described the ingredients they imported, USPlabs and SK Laboratories [the Californian manufacturer] frequently caused Chinese chemical suppliers to create and send fake COAs so that the COAs would match the lies USPlabs wanted to tell about the ingredients it was using," the indictment reads.

Benjamin Mizer, principal deputy assistant attorney-general in the US, told a press conference two weeks ago: "Much of the alleged fraud focused on the defendants' claims that their products were made from natural plant extracts ... in truth, as one defendant put it: 'LOL, [the] stuff is completely, 100% synthetic.'"

USPlabs has denied any wrongdoing, saying it stood behind "the safety and integrity" of its products and that the charges were not related to its current range.

It made similar denials two years ago after its other implicated product, OxyElite Pro, was associated with a deadly spate of liver damage cases in the US, prompting a US Food and Drug Administration alert.

The popular fat-burner, however, was removed from Dis-Chem and Clicks only after the Sunday Times raised the alarm following the US warning.

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At the time, I found three different versions of the product on the local market, including at independent supplement and health stores. Some contained the controversial ingredient 1.3dimethylamylamine (known as DMAA), yohimbe bark extract (banned in South Africa) and a new dietary ingredient, aegeline.

In its 2013 warning, the FDA said aegeline - a synthetic version of a chemical compound that exists in natural form in a tree in India - had no history of use or evidence of safety. The company had used the new ingredient to replace DMAA earlier in 2013 after the FDA received 86 reports of illness and death associated with the ingredient and banned it. DMAA was banned in South Africa at the end of that year.

After the new aegeline formula was linked to scores of cases of nonviral hepatitis - leading to several hospitalisations, two liver transplants and one death - US authorities told consumers to stop using it.

Now two years later, following a year-long investigation, USPlabs' corporate officers, including its CEO, are accused of having conspired to import ingredients from China using false certificates of analysis and false labelling - and then lied to retailers, wholesalers and consumers about the source and nature of those ingredients after putting them into its products.

The indictment says that despite the company assuring the FDA two years ago that it would stop distribution of OxyElite Pro, it had engaged in a "surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible".

Even more troubling is the allegation that USPlabs for several years instructed Chinese chemical sellers to "misbrand" shipments of different chemicals - once as "green coffee samples" - to avoid scrutiny by the authorities. And it's alleged that executives and staff "frequently tested" these chemicals on themselves.

The world's largest speciality health and wellness retailer, General Nutrition Corporation, has suspended sales of all USPlabs products "pending further review".

None of this, however, has prompted Dis-Chem or USPlabs' licensed distributor in South Africa, Bolus Distribution, to do the same.

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Dis-Chem operations director Brian Epstein defended its position by saying the Jack3d version it stocked was different to the US version.

"We temporarily removed the product from the shelves as a precautionary measure to verify that there were no traces of DMAA in it. Our supplier is the authorised exclusive agent for this product in South Africa and does not import the US version which is in question."

Had he not read the damning charges detailing the company's alleged modus operandi, I asked. Surely Dis-Chem, like consumers, couldn't trust the brand any more?

"We have not studied the indictment in detail or taken legal comment on this document," said Epstein.

Distributor Mike Bolus said he carried only the "international, toned-down versions" of Jack3d, without any banned substances.

Other versions of the product, allegedly grey imports, have been sold by local supplement stores.

On the face of it, Jack3d falls under the Medicines Control Council's regulations on complementary medicine (derived from plants, minerals or animals) that came out in November 2013.

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The rules are that if a complementary medicine was on the market before the regulations, it can remain on the shelf provided the makers apply for registration by stipulated deadlines and, in the interim, it carries an MCC disclaimer saying it hasn't been evaluated.

Bolus, who started distribution of Jack3d in 2010, said this week that the company was "in the process of applying the MCC disclaimers" and would comply with the "MCC's roadmap due out in the future". The application deadline for muscle-building agents such as Jack3d is May next year.

So what do consumers do in this vacuum of regulatory control?

Well, for starters, the MCC doesn't recommend buying complementary or any other medicine online. Second, if it's not yet MCC-approved (approved products carry a registration number) it means there is no safety, efficacy or quality data to rely on. Best to steer clear.

"Consumers should interrogate products as to MCC registration and seek out products that are compliant with various requirements," said registrar Dr Joey Gouws.

"More importantly, retailers and pharmacies need to become more vigilant, ask questions and remove products from the shelves that are not compliant."

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