Information and Alerts

Alert

BBB opened an investigation on Zudker Medical Group to establish whether they were following Canadian government regulations. In Canada if a product is sold as a health product the company requires a product licence or a site licence. 

The company sells a product called Gynexin. Gynexin™ is a proprietary natural supplement that has been reported to show significant reduction of the fatty breast tissues (subcutaneous adipose) in the mammary glands.

Advertising on the company's website states: With Gynexin™, there is no need for further embarrassment or painful surgery! Simply make Gynexin™ part of your daily routine!Gynexin™ works by targeting the fatty cells (subcutaneous adipose tissue) in the mammary glands. This unique herbal formula, developed under the direction of leading herbalists and nutritionists, has been seen to target these fatty cells and reduce them in both size and quantity, leading the way to a more masculine and happier you
 The website http://www.gynexin.com/ gives the appearance of a US based company. They use the USPS and all of their pricing is in US dollars. On https://gynexin.secureapay.com/contact/form It indicates a US postal box for Tantrum Ltd. However, a BC Online search indicates that the company is incorporated in BC and is owned by Kevin Atkinson. Research by BBB indicates there are several legal business structures available to foreign entrepreneurs and businesses wishing to conduct business in Canada. Corporations represent the most common form of legal business structure for foreign companies seeking to establish operations in Canada. Foreign entrepreneurs and businesses can incorporate a subsidiary corporation for their Canadian operations, either federally or provincially. The two most common ways in which foreigners register to operate their businesses in Canada are through the registration of a Canadian branch or the incorporation of a Canadian subsidiary. A branch office is an extension of the parent corporation's business, while a subsidiary is a separate corporation which is controlled by the parent corporation. It should be noted that a parent company may be held liable for the actions of the subsidiary, despite the latter's self-sufficiency. The company's website states "Gynexinâ„¢ works by targeting the fatty cells (subcutaneous adipose tissue) in the mammary glands. This unique formula, developed under the direction of leading medical scientists and nutritionists, has been seen to target these fatty cells and reduce them in both size and quantity."
The FDA regulates dietary supplements and according to the FDA Gynexin would be classed as a 'structure function' claim and cannot be sold in the USA.

In Canada if a product is sold as a health product the company requires a product licence or a site licence. All Canadian manufactures, packagers, labellers, and importers of natural health products must have site licences. To get a licence, sites must maintain proper distribution records, have proper procedures in place for product recall and for the handling and delivery of their products and demonstrate that they meet good manufacturing practice requirements. Natural Health supplements/products that have been licenced for sale in Canada will bear a product number (NPN) or a homeopathic medicine number (DINHM) on the label followed by an eight-digit number. The presence of a NPN or DINHM means that the product has been authorized for sale in Canada and is safe and effective when used in accordance with instructions on the label. BBB staff contacted NNHPD asking if the product was approved for sale in Canada and have an NPH? Also does the website have site licensing? Their response is: There is no NPN assigned under Zudker Medical Group as licence holder nor under brand name of Gynexin.LNHPD- Licensed Natural Health Products Directorate NPN# database can be found at following website:https://health-products.canada.ca/lnhpd-bdpsnh/index-eng.jsp

With respect to a site licence, Zudker Medical Group at the time of this investigation does not currently hold a site licence from the Natural and Non-prescription Health Products Directorate (NNHPD), nor has there been a site licence held for the address: 883 Van Isle Way.There is also no record for a company call Tantrum in Washington state, related to a Canadian importer with a site licence. Information regarding site licence holders is available on our website at:https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/site-licensing/list-site-licence-holders/list-holders.html