When push comes to shove
As my grandmother always used to say, "What's good for the goose is good for the gander." She used this adage to justify a lot of things, including her advice that my cousins and I should stand up for ourselves and fight back when we were being picked on by schoolyard bullies. Apparently, someone from the American Herbal Products Association (AHPA) heard this same advice somewhere along the line. Which prompted them to write to the FDA recently, asking for a little clarification on the agency's lopsided labeling policies. You see, more and more pharmaceutical companies have taken to combining their over-the-counter drugs with natural ingredients like herbs and vitamins and then marketing them with claims that no natural supplement would ever get away with. For example, Bayer's new "Heart Advantage" product combines aspirin with 400 milligrams of plant sterols. Normally, a product like this would have to go through a rigorous—and expensive—review process before hitting the market. But it's already on the shelves, bearing both drug and supplement labeling, as well as claims that are typically reserved for "approved" drugs. Essentially, the AHPA letter is asking the FDA "What gives?" They pointed to two previous instances where the FDA issued warning letters to companies marketing over- the-counter drug/natural supplement combinations before filing "new drug applications." And the AHPA also reminded the FDA of another letter the agency had issued in 2000 in which it "'strongly'" recommended companies not market such products, given possible health and policy issues." So why is Bayer getting special treatment? If pharmaceutical companies can make claims in the advertising for products that contain natural ingredients, why can't supplement manufacturers? Of course, the AHPA is only asking for "clarification" on these policy inconsistencies, which means that the FDA will likely "explain" its way out of the mess it created, rather than actually altering the skewed policy. But that didn't stop the AHPA from issuing the challenge—and that's something to be proud of in itself. The FDA is a schoolyard bully that has been masquerading as a government agency long enough. Let's hope more supplement manufacturers and natural-medicine organizations get tired of being pushed around and start standing up for themselves—and shoving back. Source:
"AHPA seeks FDA clarification on OTC/supplement combos," Natural Products Insider (www.naturalproductsinsider.com), 6/2/08 | 
