AHPA, IASC Petition FDA To Reconsider Aloe, Cascara SagradaRule

AHPA, IASC Petition FDA To Reconsider Aloe, Cascara SagradaRule

AUSTIN, Texas--The American Herbal Products Association (AHPA)and the International Aloe Science Council (IASC) filed a petition with the Foodand Drug Administration (FDA) June 10 requesting a stay and reconsideration ofthe agency's recent move to no longer allow aloe and cascara sagrada ingredientsin over-the-counter (OTC) laxative drug products. The final rule was recentlypublished in the May 9 Federal Register.

FDA noted that one of the reasons behind this ruling was because no onefollowed through with the agency's 1998 request to conduct more studies on thesebotanicals to ensure them GRAS (Generally Recognized As Safe) status. Both AHPA(www.ahpa.org) and IASC (www.iasc.org)argue there is general recognition that aloe and cascara sagrada ingredients aresafe and effective for laxative drug use. According to the AHPA and IASCrelease, "the failure of anyone to perform further testing cannot alonecause the ingredients to be removed from OTC drugs, as the agencycontends."

According to Michael McGuffin, AHPA president, aloe and cascara sagrada havebeen recognized as safe and effective for decades. "There is a wealth ofwell-documented evidence to support their safety, which the agency eitheroverlooked or chose to ignore," he said, adding, "The main point ofthis petition is that AHPA and IASC do not believe FDA has the authority by theprocess they used to remove these ingredients from OTC drugs."

What is to be done until AHPA and FDA iron out this issue? "I don't haveany advice for AHPA members," McGuffin told INSIDER. "The mainthing members could do is to read FDA's ruling and understand what it means totheir business." According to McGuffin, 30 years ago there were dozens ofbotanicals listed for OTC drug approval. Now, there are only a few left,including psyllium, slippery elm and witch hazel.

AHPA and IASC also requested in the joint petition that FDA clarify aloe veragel--commonly used in foods and dietary supplements--is not intended in any wayto be covered by the final rule.

Calls to FDA for comment were not returned by press time.