Vita Breath

Starting date:

June 16, 2010

Posting date:

June 16, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Poisoning Hazard

Audience:

General Public

Identification number:

RA-120001180

• Media enquiries
• Public enquiries

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

U.S. Food and Drug Administration (FDA)

Product names

 Vita Breath

Manufacturer / Place of origin

American Herbal Lab Inc. of Rosemead, California, USA

Product description

Vita Breath is promoted as an herbal dietary supplement. According to the company's Web site, www.newvita.com, the product is promoted for improvement of health in people with asthma, and to support a healthy "lung energy" and respiratory system.

According to the FDA news release, the product is marketed at health fairs in the U.S. and on the Internet.

Reason for warning

The U.S. FDA warned consumers not to buy or consume Vita Breath because it may contain hazardous levels of lead, which is a heavy metal.

Following a report of lead poisoning in a patient using Vita Breath, the FDA analyzed samples and found it to contain lead at levels 10,000 times higher than the FDA's maximum recommended level for lead in candy.

The amount of lead in the sample exceeds Health Canada limits as well.

Ingestion of excessive amounts of heavy metals poses serious health risks because they may accumulate in vital organs of the body. Children are most susceptible to the toxic effects of heavy metals.

Possible side effects

The toxic effects of lead include abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

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