FDA Recalls Dietary Supplement for Failure

Stemvida International Corporation of Ontario, California, manufacturer of StemAlive, has issued a voluntary recall of its StemAlive 90 Capsules. While dietary supplements are regulated under the 1994 Dietary Supplement Health and Education Act, responsibility for labeling, including ingredients and safe usage, is left to the manufacturer. The FDA reports that the supplement contains undeclared milk ingredients.

Those with allergy to milk who ingest the product may experience a serious and possibly life-threatening reaction. The packaging fails to include an allergen warning that milk or a by-product is in the supplement and that is required by the FDA. The FDA has not formally defined “allergens” but has specified a number of ingredients that are widely believed to be causes of allergic reactions, including milk, nuts, eggs and others.

Did you know that nearly 75% of humans worldwide have some form of lactose intolerance?

Milk allergy and lactose intolerance are often confused because they share some of the same symptoms. Lactose intolerance is the result of an enzyme deficiency while milk allergy is an immune response to the protein in milk. Stomach pain, nausea and diarrhea are common symptoms of both conditions.

Though rare, the most severe allergic reaction to milk can result in anaphylactic shock, which may cause swelling of the throat, difficulty breathing, a drop in blood pressure and can possibly lead to cardiac arrest. Other symptoms include wheezing, vomiting and hives.

Lactose intolerance increases with age, according to Dr. Amy Bartow of the Lahey Clinic in Burlington, Massachusetts, and an estimated 30 to 50 million Americans suffer from lactose intolerance. Milk allergy, however, is less common in adults; most children outgrow milk allergy by age 3, according to the Mayo Clinic.

So far, no illnesses have been reported. Consumers who have purchased StemAlive 90 Capsules are encouraged to contact the manufacturer for a refund or replacement.