Pacific BioLogic Initiates Recall for Aristolochic Acid Products 30834

Pacific BioLogic Initiates Recall for Aristolochic Acid Products

WASHINGTON--Pacific BioLogic Co., based in Clayton, Calif., voluntarily recalled four products containing Akebia Trifoliata Caulis (Mu Tong) and Asarum Sieboldii Herba cum Radix (Xi Xin), both containing potentially toxic aristolochic acid. The company instigated the recall following a July 13 member e-mail by the American Herbal Products Association (AHPA), sent as a follow up to the Food and Drug Administration's (FDA) aristolochic acid advisory in April.

CurtisJacquot, owner of Pacific BioLogic (www.pacificbiologic.com), stated that the e-mail drew his attention to FDA's "B-list" of herbs containing aristolochic acid. When the company double-checked its products against the list, it found four products containing two of those herbs. Even though the company immediately recalled those products, Jacquot stated that he feels these herbs are only dangerous at extremely high levels. "I don't think enough research was done by FDA on the B-listed herbs," he stated. "However, we're working diligently with the FDA and cooperating to our absolute fullest ability."

The recall affected Herbal Masters Arpanex B (also known as Balance & Harmony Artiflex B), Herbal Masters Cys (also known as Balance & Harmony Gentiana Combination), Herbal Masters Koms A (also known as Balance & Harmony Allerhay) and Pacific Biologic Orthoflex.

"The company did the right thing," said MichaelMcGuffin, president of AHPA (www.ahpa.org). "This was a tough business decision, but it's tougher when FDA finds out on its own." In regard to AHPA having played a role in aiding this recall, he stated, "There's some satisfaction in knowing that the industry is listening to us. It would be more satisfying if FDA gave us more of a leadership role since we are a rich resource at its disposal."

No illnesses have been reported from these products, and the company plans to send letters about the recall to its distributors, retailers and wholesalers. In all, 550 bottles were destroyed by the company.