Black Gorilla, Big N Hard, Rize N Shine, and the likes: Fraudulent health business

November 05, 2017 – The commercial names are creative, no doubt, and we like particularly “Black Gorilla”. However, time and time again, health authorities all over have to issue foreign product alerts, warning consumers, patients, and the public at large about products that claim to be “all natural” while in fact they are plain and simple fortified, undeclared of course, with powerful prescription drugs. This is fraud at the base of big health related business and voluntarily will harm consumers and patients alike.

Black Gorilla thinking.

The point in case is the latest series of foreign product alert (FPA) communications issued by Health Canada. A first alert was concerned with products by the names of Big N Hard, Black Gorilla, Cummor, Dragon Max, Oh Baby!, Man XXX, Maxman IV, Maxman Premium, Maxman V, Monkey Business, MMC Maxman XI, MME Maxman IX capsules, New Advanced Technological, V9 Male Sexual Stimulant, Real Skill Male Sexual Stimulant, Rize N Shine, Tornado, Xrect, XXXL Penis Enlarging Ointment, Z Daily. From the product names, it will be easy for our readers to conclude at whom these products are targeted, and what the business volume in this area may be worldwide.

Taking into account the seaming worldwide obsession with male performance, it comes as no surprise that such “all natural” products need to be fortified  in order to fulfil their (most of times unsubstantiated) promises. As a consequence, they contain undeclared pharmacologically active compounds, such as sildenafil, tadalafil, N-desmethyl tadalafil, levodopa, nortadalafil, descarbonsildenafil, and homosildenafil of unknown quality and unknown dose. Of course, sildenafil and tadalafil are the pharmacologically active ingredients of the prescription drugs Viagra and Cialis, which are used to treat erectile dysfunction (ED); the other, pharmacologically similar compounds are worldwide unauthorised.

 With respect to the communication of Health Canada, we need understand that these foreign health products have been found by regulators in other countries to contain these undeclared drug ingredients. The products are not authorized for sale in Canada and have not been found in the Canadian marketplace. However, it is possible they may have been brought into the country by travellers or purchased over the Internet. In such case, you should i) contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace, ii) onsult a healthcare professional if you have health concerns related to the use of any of these products, and iii) read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM).
Similarly, a recent second and third foreign product alert (FPA) by Health Canada have been concerned with “Unauthorized “E-Fong XuDuan Concentrated Herb Tea” and “Body Con Plus capsules, Physic Candy – Define, 7-Day Slim Extreme capsules”, respectively. The former product may pose very serious health risks, including an increased risk of miscarriage and birth defects in that the tea contains trace amounts of mycophenolate, which in itself is a prescription drug. The later products may equally use serious health risks in that they may contain phenolphthalein which was previously used as a laxative, but is no longer authorized for sale in Canada because it may cause cancer, along with additional side effects including decreased blood pressure, skin rash, and gastrointestinal bleeding, and sibutramine, which was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke, along with other side effects include increased blood pressure and heart rate, dry mouth, difficulty of sleeping, and constipation.

While we have used here recent communications by Health Canada as a point in case, we have to be clear about the issue: Consumers, patients, and authorities  have to fight permanently fraudulent products appearing on the market with unsubstantiated claims of health and well being. As authorities worldwide fight against dangerous counterfeit and unapproved medical products in the “Operation Pangea“, similar operations are needed in the worldwide fight against counterfeit and fraudulent “all natural products” in the favour of protection of uninformed, or desperate, or hopeless consumers and patients whatever their motivation for craving for “all natural products” or alternative medicines may be.

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About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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