Health Canada is warning that all products manufactured by Professional Botanicals Inc. may pose serious health risks. The company is a contract manufacturer that also operates under the name Healthy Botanicals Inc.
OTTAWA, Dec. 13, 2018 /CNW/ -
Issue
Health Canada is warning that all products manufactured by Professional Botanicals Inc. may pose serious health risks. The company is a contract manufacturer that also operates under the name Healthy Botanicals Inc.
Health Canada’s assessment indicates that the company was manufacturing products under unsanitary conditions at a site that was not licensed by Health Canada at the time. During an inspection of the site (located at #16, 17075 Leslie Street, Newmarket, ON), Health Canada inspectors found that there was a lack of adequate quality control measures to ensure product quality and safety, and that no pest control measures were in place.
Health Canada has seized all of the products, prescription drug ingredients and manufacturing equipment found at the site, and suspended the 11 natural health product licences held by the company.
Products manufactured by this company may have been sold under various brand names, including Professional Botanicals Inc., either directly from the company or distributed to locations such as retail stores and weight loss clinics.
Health Canada’s actions are further to the Department’s follow-up regarding the sale of Vita-X Revitalizing Capsules, a natural health product manufactured by this company that was found to contain a prescription drug. As previously communicated, Health Canada has also suspended the licence for this product.
Unauthorized products have not been assessed by Health Canada for safety, quality or efficacy. It is illegal to sell unauthorized health products and conduct activities such as manufacturing, packaging and labelling of health products in Canada without the appropriate licensing and authorization from Health Canada. A site or establishment licence indicates that the company has met Health Canada’s requirements for having processes and procedures in place to track and recall health products, and for manufacturing, packaging and labelling products in accordance with good manufacturing practices (a standard that helps to ensure the quality of health products sold to Canadians).
Who is affected
- Consumers who have bought or used the affected products.
Affected products
List of products for which Health Canada has suspended the licence (licenced products are indicated on the label by a Natural Product Number [NPN])
| Product | NPN | Claim |
| 80029981 | Help maintain and/or support cardiovascular health in adults | |
| 80032208 | Help relieve inflammatory conditions of gastrointestinal tract and mild digestive disturbances. Traditionally used as a calmative and/or sleep aid | |
| 80032258 | Help support cognitive function and/or reduce mental fatigue. Help enhance physical capacity and performance (in case of physical stress) | |
| 80033038 | Source of antioxidants for the maintenance of good health. To be used with a program of reduced intake of dietary calories and increased physical activity (if possible) to help in weight management | |
| 80033667 | Source of antioxidants for the maintenance of good health | |
| 80032373 | Help support peripheral circulation | |
| 80032200 | Help support liver function | |
| 80032472 | A factor in the maintenance of good health | |
| 80033081 | Help reduce elevated blood lipid levels and hyperlipidaemia and maintain cardiovascular health in adults | |
| 80032564 | Provides antioxidants for the maintenance of good health | |
| 80032468 | Provides antioxidants for the maintenance of good health |
List of unauthorized products that Health Canada seized from the site (see photos below):
| Product | Size | Claim (according to the label) |
| Bulk Supplements.com Longjack Extract (Tongkat Ali) | 100g | No promoted use or claims on label |
| EU Pharma XXX-Lean | 120 capsules | Weight loss |
| Herbal Lifestyle | 20 capsules | Weight loss |
| Nature’s Clinic Happy Drops | 100 mL | No promoted use or claims on label |
| Neutrix Limbada | 10 capsules 100 capsules | Workout aid, sexual enhancement |
| Neutrix Limbada Jack | 2 capsules 20 capsules | Sexual enhancement |
| Neutrix Red Rocket | 10 capsules | Workout aid, sexual enhancement |
| Professional Botanicals Inc. Alpha Lipoic Acid | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Beta-Sitosterol Plus | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Body Slim | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Bovadrene | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. CandiaStat | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Children Dewormer | 500 mL | No promoted use or claims on label |
| Professional Botanicals Inc. Co-Enzyme Q10 | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Colostrum | 60 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. DHEA | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Diabetol | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Digizyme | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. EDTA | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Glucosamine Chondroitin and MSM | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. IB-Relieve | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. L-Arginine | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. L-Carnitine | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. L-Glutamine | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Limbada Fertility | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Lipid Formula 1 | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. MSM Cream | 30 mL | Joint pain relief |
| Professional Botanicals Inc. Nattokinase Plus | 90 capsules | Reduce blood pressure, prevent blood clots, promote vascular health |
| Professional Botanicals Inc. Oral Chelate | 90 capsules | Heavy metal removal, chelating agent |
| Professional Botanicals Inc. Paragona | 90 capsules | Targets parasites of the gastrointestinal tract |
| Professional Botanicals Inc. Phytotheanine | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Probiotics | 90 capsules | Relieve symptoms of allergy, cold, flu or arthritis, regulate digestion and fat metabolism |
| Professional Botanicals Inc. Prostasol | 90 capsules | Reduce bloating and water retention, improve sleep, promote urinary tract and prostate health |
| Professional Botanicals Inc. Rheumaplex | 90 capsules | Helps reduce pain, stiffness, inflammation and swelling in joints due to arthritis |
| Professional Botanicals Inc. Thyrone | 90 capsules | No promoted use or claims on label |
| Professional Botanicals Inc. Varicon Plus | 90 capsules | No promoted use or claims on label |
What consumers should do
- Stop using these products. Consult your health care professional if you have used any of these products and have health concerns.
- Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have a valid authorization for sale by searching Health Canada’s Drug Product Database and Licensed Natural Health Product Database.
- Report any health product-related adverse reactions or complaints to Health Canada.
What Health Canada is doing
At Health Canada’s request, the company has agreed to stop manufacturing and selling, and to recall, all health products manufactured at its facility.
Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.
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SOURCE Health Canada
