Advisory - Health products manufactured by Professional Botanicals Inc. may pose serious health risks

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.

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Advisory - Health products manufactured by Professional Botanicals Inc. may pose serious health risks (CNW Group/Health Canada)

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
Arterial Supreme 500 Ml	80029981	Help maintain and/or support cardiovascular health in adults
Chamomilla Supreme	80032208	Help relieve inflammatory conditions of gastrointestinal tract and mild digestive disturbances. Traditionally used as a calmative and/or sleep aid
Ginseng Herbal Medicine	80032258	Help support cognitive function and/or reduce mental fatigue. Help enhance physical capacity and performance (in case of physical stress)
Green Tea Extract	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
Green Tea Extract	80033667	Source of antioxidants for the maintenance of good health
Limbada	80032373	Help support peripheral circulation
Liversol; Liver Supreme	80032200	Help support liver function
Magnesium & Potassium	80032472	A factor in the maintenance of good health
Mega Garlic	80033081	Help reduce elevated blood lipid levels and hyperlipidaemia and maintain cardiovascular health in adults
Opc Flow	80032564	Provides antioxidants for the maintenance of good health
V Tonic	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

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709