FDA Regulatory Insights
Cara Welch, PhD, acting director of the Division of Dietary Supplement Programs at FDA’s Center for Food Safety and Applied Nutrition (CFSAN) provided an overview of the agency’s current priorities for enforcement of dietary supplement regulations. Dr. Welch noted that FDA is seeing some progress in supplement manufacturer compliance with current good manufacturing practice (cGMP) requirements, but this isn’t reflected in compliance data because the data currently don’t provide sufficient detail. For example, a company that has no master manufacturing record (MMR) is recorded the same as a company that has most MMRs, but not all that are required.
Dr. Welch said the division’s immediate plans include finding a way to issue a more granular assessment of industry compliance.
Jenny Scott, senior advisor at the Office of Food Safety in CFSAN provided an overview of the new regulations that will implement the Food Safety Modernization Act (FSMA). She encouraged companies to submit specific questions about FSMA to FDA to receive personalized guidance.
Douglas Gansler, former Maryland attorney general and currently a partner at BuckleySandler LLP, delivered the keynote lunch address and stressed the need for the herbal products industry to be politically active and engaged. Mr. Gansler noted that the herbal products industry has grown too large to fly under the radar and encouraged companies to initiate relationships with their state attorney general to help get ahead of issues.
“You don’t want your first meeting with your attorney general to come after a press conference,” Mr. Gansler said.
Michael Smith, MD, the spokesperson for Life Extension and host of Healthy Talk on RadioMD.com, emphasized that the New York Attorney General’s investigation provides a great opportunity for the industry to help consumers understand the difference between drugs and supplements. He urged the industry to refrain from being defensive and instead agree with consumer concerns and then educate them.
Global Supply Chain & Market Insights
Chris Kilham, founder of Medicine Hunter Inc., used the recent boom in maca root to highlight the complexities of the global ingredient supply chain. He noted that maca’s popularity among China’s massive and growing middle class has had wide-ranging repercussions, including threatening the supply for other countries, biopiracy, violence, an increase in low-quality maca and natives unable to purchase their traditional food. This example highlights the need to enact strategies to ensure sustainable harvests of valuable botanicals.
Joseph Brinckman, vice president of sustainability at Traditional Medicinals, stressed that establishing trust and personal relationships through the supply chain can prevent most supply problems. He also stressed the importance of specifying standards, spreading risk and planning years ahead.
Amanda Hartzmark, research associate at Euromonitor International, provided an overview of global herbal product sales noting that products that combine drugs and botanicals, topical analgesics and fiber are all growing market segments.
Diane Ray, vice president of strategic innovation at Natural Marketing Institute (NMI), highlighted the recent growth of herbal supplement use and stressed there are many opportunities for additional growth, specifically among women, Millennials and Generation Xers.
Ms. Ray also noted that only 14% of all consumers heard about the NY AG investigation and only 25% of herbal supplement consumers heard about the investigation.
“Yes, this is important. Yes, this warrants a response,” she said. “But it isn’t time to panic.”
Botanical Identification Technology
A panel of experts on analytical methods for botanical identity provided several examples to explain why plants present unique challenges to accurately identify.
Dr. Antoine Bily, research and development director at Naturex, noted that a botany lab is different than a traditional chemical lab because of the complexity of plants, caused in part by diversity and hybridization, which result in complex matrices. Kurt Reynertson, chemist, botanist and pharmacologist, stressed that every plant has a unique history before it gets to a manufacturing facility, and this means there will always be variability, because every variable can’t be controlled.
To meet this challenge, James Traub, senior business development manager of natural products, pharmaceutical business at Waters Corporation, highlighted how technology has become more sophisticated, smaller, cheaper and simpler to use, making it easier for companies to verify identity and quality.
Maged Sharaf, PhD
American Herbal Products Association (AHPA)
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products. Before AHPA, Dr. Sharaf was the director, Foods, Dietary Supplements and Herbal Medicines at the United States Pharmacopeial Convention (USP). Before USP he was pharmacy associate professor and has preceding experience conducting bioanalytical assay development and validation, and human bioequivalence studies in support of the pharmaceutical industry; and quality control and manufacturing of pharmaceutical dosage forms. He can be reached at 301-588-1171; E-mail: email@example.com; Website: www.ahpa.org.