Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Starting date:
August 27, 2018
Posting date:
August 27, 2018
Type of communication:
Advisory
Subcategory:
Drugs, Natural health products, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Important Safety Information, Unauthorized products
Audience:
General Public
Identification number:
RA-67602

Issue

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11 products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Affected products

The products listed below have not been evaluated by Health Canada for safety, effectiveness or quality and may pose serious health risks.

Product Label to contain
Androtechnologies DHEA Dehydroepiandrosterone (DHEA)
Dust Extreme Pineapple Mango Dimethylamylamine (DMAA)
Ephedrine Hydrochloride Ephedrine
High Potency 4-AD Androstenediol
High Potency Vitamin D3 Vitamin D 5,000IU
Highest Potency Vitamin D3 Vitamin D 10,000IU
Lipo-Cuts Hardcore Ephedra alkaloid, caffeine and yohimbe
Muscle Systems 1-AD Androstenediol
Prime Nutrition Yohimbine Yohimbine
The Ultimate hCG Weight Loss Solution Human Chorionic Gonadotropin (HCG)
Vita Plus D.H.E.A. Dehydroepiandrosterone (DHEA)

 

What you should do

  • Stop using these products. Consult your health care professional if you have used these products and have health concerns.
  • Learn how to minimize your risks when considering health products for weight management.
  • Be skeptical about advertising claims for weight-loss products. If a product sounds too good to be true, it probably is.
  • 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), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
  • Report any health product adverse events or complaints to Health Canada.

Who is affected

  • Canadians who have bought or used these products

Background

Androstenediol is a controlled substance in Canada. It is a steroid hormone (anabolic steroid) used by the body to make testosterone and estrogen. Potential long-term adverse health effects in men include shrinking of the testicles, impotence and development of female characteristics such as breast enlargement. Women who use these products may develop male characteristics such as male pattern baldness, deepening of the voice, increased facial hair, and enlargement of the clitoris, as well as abnormal menstrual cycles, abnormal bleeding and blood clots. Women may also be at increased risk for breast cancer and endometrial cancer, as well as aggravation of endometriosis and fibroids, and depression. Children and adolescents are at risk of effects similar to those experienced by adults, as well as for early onset of puberty, and for premature cessation of growth, such that they will be short as adults.

Dehydroepiandrosterone (DHEA) is a controlled substance that can cause higher-than-normal levels of female and male hormones in the body and could increase the risk of prostate, breast, ovarian and other hormone-sensitive cancers. Potential side effects include serious cardiovascular disease, changes in fertility and sperm production. DHEA should be avoided by individuals with a history of abnormal heart rhythms, blood clotting disorders, liver disease and those who are pregnant or breast-feeding.

Dimethylamylamine (DMAA) is a drug that is not authorized for use in Canada. Side effects include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.

Ephedrine/Ephedra (and its alkaloids) is a drug and a stimulant. The use of products containing ephedra/ephedrine is not recommended in people with heart problems, hypertension, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma (serious eye disorder) and pheochromocytoma (serious gland disorder) because ephedra/ephedrine aggravates these conditions. These products should also be avoided during pregnancy and lactation. Ephedrine/Ephedra (and its alkaloids) taken in combination with caffeine can cause symptoms ranging from dizziness, tremors, headaches and irregularities in heart rate to seizures, psychosis, heart attacks and stroke.

Human Chorionic Gonadotropin (hCG) is a prescription drug authorized in Canada as an injectable for the treatment of hormone-related conditions such as infertility. It should be used only under the supervision of a healthcare professional. Risks associated with hCG—whether used for authorized indications or weight loss—include: blood clots; depression; hyper-stimulation of the ovaries (which can lead to severely enlarged and painful cysts and abdominal distension, difficulty breathing and life-threatening imbalances in blood volume), multiple pregnancy (two or more babies in the uterus) and false pregnancy tests in women; and fluid retention and gynecomastia (breast enlargement) in men.

Vitamin D is a prescription drug when the product is taken by mouth and has a recommended daily dose that is more than 1,000 International Units (IU). Excessive levels of vitamin D can lead to vitamin D "intoxication," which can cause headache, nausea, vomiting, constipation, lack of appetite, irritability, dehydration, fatigue and weight loss. Pregnant women in particular should not take vitamin D exceeding the daily tolerable upper intake level for adults (4,000 IU).

Yohimbine/yohimbe is a prescription drug and should be used only under the supervision of a health care professional. Yohimbine is derived from yohimbe, a bark extract. The use of yohimbine or yohimbe may result in serious adverse reactions, particularly in people with high blood pressure, or heart, kidney or liver disease. Side effects include increased blood pressure and heart rate, anxiety, dizziness, tremors, headache, nausea and sleep disorders. It should not be used by children, or pregnant or nursing women.


Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada seized the 11 unauthorized products from Vitality Health Foods, 5125 51st Avenue, Drayton Valley, AB. Additional actions will be taken if further unauthorized products or suppliers are identified.

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