Today, FDA issued a Public Notification (here) indicating that the supplement Alpha Male marketed with a tag line of “Knock it out of the Park with Alpha Male!” contains derivatives of both tadalafil (the active ingredient in Cialis) and derivatives of sildenafil (the active ingredient in Viagra). This is just another in a long line of supplemental products containing adulterants that makes them not only new drugs, but also dangerous.
Who makes these things and how do they think they can market them legally?
In a recent interview (here), Dr. Daniel Fabricant, Director, Division of Dietary Supplement Programs at the Agency suggested that Dietary Supplement firms still are not on board with following the dietary supplement good manufacturing practices and many companies even fail to set appropriate specifications. There are 180 million people that take dietary ingredients and people should have an expectation that the products they take “meet minimum quality standards and aren’t contaminated with things that are adulterants.” He also noted that many firms are introducing new dietary ingredients that might be similar to other previously marketed ingredients, but are not identical. He stressed that those firms must go through the New Dietary Ingredient 75-day notification process providing information demonstrating that the new ingredient is safe. Dietary supplements are supposed to be a normal part of the dietary requirements. Clearly, there are a number of firms that are not overly cautious to assure that their products meet the FDA requirements for marketing.
In yet another story reported on FDAWebview today (paid subscription required), a Puerto Rican- based firm has recalled one lot of its Adipotrim XT “natural” weight loss product because laboratory tests revealed the product contained undeclared fluoxetine (the active ingredient in Prozac).
As I have stated before, perhaps it is time for the entire dietary supplement process in this country to be reevaluated ,especially with so many cases of adulterated dietary supplement products marketed that contain either active drug substances or derivatives of active drug substances that cause the products to be misbranded.
For more information on dietary supplements, please contact Joan Janulis at Lachman Consultants (j.janulis@LachmanConsultants.com)