South African consumers are in the dark after Dis-Chem promptly removed the pre-workout fitness supplement Jack3d from their shelves on 26 November.
This just days after Health24 initiated an investigation into whether the version of Jack3d on sale online from a number of SA vendors, as well as the Dis-Chem group of pharmacies, contained the illegal ingredient 1-3-Dimethylamylamine - DMAA or Methylexaneamine, also known as Geranium extract (see below for other namings).
What spurred our investigation is the news that, on 17 November, USPlabs (who manufacture and distribute Jack3d) and its executives were indicted by the US Department of Justice on 11 charges relating to the manufacture and sale of, among other products, Jack3d.
The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis (COAs) and false labelling, and lied about the source and nature of the ingredients after putting them in the products.
Download the charge sheet here
The US government argues that this deception was deliberate.
"USPlabs and its principals embarked on an unmistakable course of conduct where, starting at least with DMAA, they imported numerous shipments of substances intended for human consumption using false and fraudulent COAs, and other false and fraudulent documentation and labeling."
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. In fact, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
In South Africa Jack3d is distributed by Bolus, who on its Facebook profile states that is the exclusive South African distributor of Jack3d. It is also Dis-Chem's supplier of Jack3d.
Ron Read, the Chief Operating Officer of Bolus Distribution told Health24 in an email that the Jack3d they supplied Dis-Chem was the international version, imported from USPlabs in the US. He states that the DMAA version was never supplied to Dis-Chem, and neither did Bolus ever import the DMAA version.
He assured Health24 that Jack3d sold in South Africa (by himself and Dis-Chem) is safe for consumption.
Read told Health24 "There are two versions of Jack3d, a U.S.A Version (which contains Yohimbine) and an International version. The Jack3d version which you are referring (containing DMAA) was a U.S Version which was discontinued in 2012 and was never imported by us."
Read has assured Health24 that he would forward Health24 a copy of the COA on Monday 30 November.
Health24 found that the product's description section on Bolus Distribution's website implied that Jack3d (as sold on the bolus.co.za website) contains 1-3-Dimethylamylamine HCI (DMAA), which is on the World Anti-Doping Agency's banned list.
The Description tab has since been removed. DMAA is also not listed on the Supplement facts tab, which shows the product label. When questioned about why it was removed, Read said: "The website had been revamped recently and the Web developers used information found on the net to cover the products description."
Image: Google webcache snapshot of Jack3d product description on Bolus.co.za, taken on 27 November.
Read: Lawsuits against makers of Jack3d
The original version of Jack3d came into disrepute for containing the ingredient DMAA which is banned in South Africa, the UK, US, Europe and New Zealand. It is used for attention deficit-hyperactive disorder (ADHD), weight loss, athletic performance, and body building. It is also used as a nasal decongestant and to improve cognitive function.
It was also the ingredient that saw springboks Bjorn Basson and Chilliboy Ralepele sent home from a rugby tour in 2010 when they tested positive for the chemical.
Read: Are there any 'safe' sports supplements?
It's concerning that, in the US indictment of USPlabs, the Department of Justice stated that USPLabs tried to sell as much as possible before it could be seized.
The criminal charges against USPlabs are serious enough that, as Reuters reports, nutritional products retailer GNC Holdings Inc was suspending sales of all products manufactured by the company.
So does the versions sold in SA contain DMAA or not?
Dis-Chem may be in the clear, if what's on the label is all that's in the bottle, and pending the lab results, but other vendors are not.
We found Jack3d containing 1,3-Dimethylamylamine HCI at Xtreme Nutrition in Canal Walk in Cape Town. Jack3d containing DMAA is also widely available over the Internet, including from vendors such as Ebay.com, Chromesa.co.za (containing the banned substance Yohimbe, not DMAA) and Xtremenutrition.co.za - see screenshot taken on 27 November. Xtremenutrition is based in Umhlanga, KZN and has at the time of publishing (27 November) not returned our mails requesting information other than saying that there are currently 3 versions of Jack3d available on the market. On the Jack3d product page they boldly state that the product contains DMAA.
So the three versions are: Jack3d that does not contain DMAA, Jack3d with Yohimbe, and Jack3d with DMAA.
Update 29 November: Jack3d has been removed from Xtremenutrition's website.
Screenshot of Jack3d with DMAA from Xtremenutrition.co.za
Read: Supplement manufacturers take advertising authority to court
Shortly after Health24's inquiry, Dis-Chem Pharmacies, SA’s second-biggest retail chain of chemists by number of stores, removed the products from their shelves.
"The current product has been sent to a local lab for confirmation that the ingredients per the label are same as the product. The results will be available in about 3 weeks. As a precautionary measure Dis-Chem has removed the article from its shelves awaiting the lab report," Read told Health24.
"We have never purchased or sold any of the U.S versions of USP Labs - only the toned down International Version which is also sold in Australia and Europe," said Dis-Chem Pharmacies Operations Director Brian Epstein.
UPDATE 30/10: Dis-Chem conducted an independent analysis of 4 versions of Jack3d and sent us the report. No traces of DMMA were found in any of their products. You can view the report here.
Image: Jack3d Advanced formula for sale on the Dis-Chem website.
What can be done to protect SA consumers against companies such as USPlabs?
The Medicines Control Council (MCC) told Health24 that it has initiated an investigation into Jack3d.
MCC head of inspection and law enforcement Dr Joey Gouws told Health24 the Medicines and Related Substances Act of 1965 (Act 101 of 1965) calls for substances containing in a medicine be listed in one of 9 Schedules to the Act.
Read: Methylexaneamine: the latest doping drug?
"On investigation I wish to confirm that the following substance: 1,3 Dimethylamylamine is listed as a Schedule 7 substance to the Medicine Act making it illegal to be sold."
Gouws pointed out some common names for the same ingredient:
• 1,3 DMAA/
• 1,3 dimethylpentylamine
She also noted that what often happens is that for the South African market, companies will delete a specific substance from the list of ingredients to ensure that sales are allowed in the country.
"Please be advised that our office and specifically the Unit: Law Enforcement will be requested to investigate this matter and report on the matter. Appropriate steps will be taken if indeed the product is shown to contain the said banned substance."
Gouws warned that DMAA is associated with the occurrence of high blood pressure, nausea/vomiting, cerebral haemorrhage, stroke and death.
Jack3d also contains 150g of caffeine per scoop, which more than double what's found in a regular can of cola.
"During sports activities, the sport man/woman is already putting their vital organs and specifically their heart under stress. By taking DMAA additional stress and risk to sports people increases."
The US Human Performance Resource Center reported in May 2014 that, "according to an FDA announcement in July 2013, USPLabs destroyed its remaining stock of the original Jack3d (as well as DMAA-containing OxyElite Pro). However, the original version of Jack3d may still be available from some online retail outlets.
Be sure to check the label for ingredients, as it is now considered illegal to sell the version containing DMAA.
Note: Jack3d should not be confused with Jack3d Micro or Jack3d Advanced Formula (both from the same manufacturer), which do not list DMAA as an ingredient.
As of early February 2014, the Natural Medicines Comprehensive Database (NMCD) has given both a rating of “2” — their second-lowest rating, which indicates serious concerns about the safety and/or effectiveness of these products. Visit NMCD for possible changes to formulas and ratings since then.
*Health24 will continue to update readers on this story as more facts come to light.
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Click here for a list of supplements containing DMAA