AHPA, IASC Petition FDA To Reconsider Aloe, Cascara Sagrada Rule

AUSTIN, Texas--The American Herbal Products Association (AHPA) and the International Aloe Science Council (IASC) filed a petition with the Food and Drug Administration (FDA) June 10 requesting a stay and reconsideration of the agency's recent move to no longer allow aloe and cascara sagrada ingredients in over-the-counter (OTC) laxative drug products. The final rule was recently published in the May 9 Federal Register. (For the INSIDER story on FDA's final rule, visit www.naturalproductsinsider.com/hotnews/25h8142714.html.)

FDA noted that one of the reasons behind this ruling was because no one followed through with the agency's 1998 request to conduct more studies on these botanicals 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 are safe and effective for laxative drug use. According to the AHPA and IASC release, "the failure of anyone to perform further testing cannot alone cause the ingredients to be removed from OTC drugs, as the agency contends."

According to Michael McGuffin, AHPA president, aloe and cascara sagrada have been recognized as safe and effective for decades. "There is a wealth of well-documented evidence to support their safety, which the agency either overlooked or chose to ignore," he said, adding, "The main point of this petition is that AHPA and IASC do not believe FDA has the authority by the process 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 have any advice for AHPA members," McGuffin told INSIDER. "The main thing members could do is to read FDA's ruling and understand what it means to their business." According to McGuffin, 30 years ago there were dozens of botanicals 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 vera gel--commonly used in foods and dietary supplements--is not intended in any way to be covered by the final rule.

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