FDA Alerts manufacturer of potent carcinogen found in herbal allergy formula

WELLESLEY, MA - January 19, 2001 - BMK International is voluntarily recalling Neo Concept Aller Relief after receiving notification from the FDA that the product contains trace amounts of aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain aristolochic acid have been associated with several occurrences of kidney failure in Europe. The use of aristolochic acid containing products has also been linked to the increase risk of kidney cancer in people who have consumed it.

Aller Relief was distributed nationwide to licensed health care practitioners, and retail outlets. Aller Relief is packaged in 30-ct. and 90-.ct. capsules. The lot numbers covered in this recall are 30-ct. and 90-ct.: #003480, #0006480.

No complaints or reports illnesses have been reported to date.

The recall is a result of the FDA notification that recommended manufacturers test their products that contain herbs that may be contaminated with aristolochic acid. The company was informed by the FDA that the product contains trace amounts of aristolochic acid and thus is conducting a voluntary recall. The company has reformulated the Aller Relief product to ensure that in the future no herb in the formula contains or may be adulterated with aristolochic acid. The reformulated product will available shortly.

Consumers with questions can call telephone: (781) 235-9999. Consumers should return the product to the place of purchase for a full cash refund.

Dr. Hansen’s Note: I am glad that BMK has issued a voluntary recall and that no complaints or reports illnesses have been reported from the use of this product to date. However, I am concerned by this discovery. This herb is a known adulterant and recently found to cause kidney toxicity and possibly cancer. The problem is that unless a company knows its sources, especially with respect to Chinese herbs, it may get more or less than it bargained for. The bottom line is, only buy your herbal products from a company you can trust. Be wary of cheap Chinese imports. But, don’t despair, there are safe, high quality products available.

For allergy relief, I recommend Flavinox. It contains only the highest quality herbs that we put through the most rigorous of testing. For example, Flavinox contains standardized herbs that we import from Indena, Spa., of Milan, Italy. Indena is a 70-year-old Pharmaceutical company that manufactures herbs for the pharmaceutical industry in Europe. They follow the same high standards required to make drugs, but use natural herbal / plant materials instead of synthetic chemicals.

If you want the peace of mind that you are buying the safest and the best, you can count on Dr. Hansen’s Vital Formulations to deliver. As the formulating physician, this is my credo: Purity, Potency, Safety and Effectiveness! All of Dr. Hansen’s Vital Formulations contain only the highest quality standardized ingredients, meeting or exceeding the amounts listed on the label and nothing else. No contamination, adulteration, impurities allowed. We inspect every batch to be certain so you don’t have to worry.

For more information about Flavinox for Allergies, click here: Flavinox

For more information about Vital Formulation’s Quality Control Standards, click here: Our Company