Industry trade organization, Organic & Natural Health Association (Organic & Natural) met with the New York attorney general’s office on April 15, in an effort to bridge communication gaps between the millions of consumers who want quality dietary supplement and herbal products and the companies that make them. The meeting was set in response to the comprehensive investigation of herbal products being led by New York Attorney General Eric Schneiderman.
“Our meeting was encouraging as it is clear we have common goals that revolve around ensuring consumers are purchasing products that can be verified for quality ingredients at the earliest possible point in the manufacturing process,” said Karen Howard, CEO and executive director of Organic & Natural. “There has been an overemphasis on scrutinizing testing methods by the natural products industry when the real issue at hand is elevating transparency to the point that consumers feel fully informed and empowered by their purchase. This can only be accomplished through honest relationships and full disclosure between companies and consumers.”
Organic & Natural formed just eight months ago by industry leaders and experts who were frustrated with the lack of true transparency between business and consumer groups when it comes to quality organic and natural products. Since officially launching in October, the group has worked towards developing a certification program for ‘natural’ products, including forging a definition of the term ‘natural’ based on consensus among business and consumer organizations; and facilitating scientific research on supplement ingredients and products that impact a person’s health and wellbeing. Organic & Natural is the first trade organization to meet with the New York attorney general’s office on his investigation into the herbal supplement industry.
During the meeting, Todd Harrison, partner at Venable, LLP, and president of Organic & Natural, agreed that there is common ground between industry and state attorneys general in regards to ensuring appropriate measures are taken to safeguard the integrity around the industry’s supply chain. He said both sides should work with each other as well as with the U.S. Food and Drug Administration (FDA) to achieve that common goal, and while there will be debates on key issues, Harrison says an open and honest communication line is the best strategy to overcome differences that will ultimately improve the natural products industry and be in the best interest of the consumer.
“Ensuring supply chain integrity must start at the earliest possible point, which means manufacturers of raw ingredients need a strong working relationship with farmers and that appropriate cGMPs (current good manufacturing practices) be instituted at the point where raw materials are manufactured,” said Harrison. “It would make sense to apply the FDA’s current cGMPs (code 21 CFR Part 111) to raw material manufacturers. Not only does it provide flexibility but would also be welcomed by branded ingredient manufactures that are already following cGMPs but are forced to compete with lower quality ingredient manufactures that have minimal, if any, cGMPs.”
Harrison believes it is also important for the FDA to clarify the obligations of private-label distributors under 21 CFR Part 111, as there is significant confusion to their responsibility evidenced in the warning letters issued by FDA.
“Applying Part 111 is necessary to supply chain integrity,” said Harrison. “We believe it is crucial to transparency and traceability when it comes to herbal and dietary supplements.”
Organic & Natural will file a citizen petition with the FDA by the end of the month, requesting the FDA amend current regulation in order to bring raw material manufacturers under 21 CFR Part 111 and to clarify the private-label distributors obligations under those standards.
“Our intention is to keep an open dialog with the attorneys general offices on supply chain integrity and to work with them on the primary goal of making sure consumers have confidence in the authenticity and purity of the products they are purchasing,” said Harrison.
Organic & Natural plans to host a supply chain integrity webinar for companies within the industry on June 24. Learn more at: http://www.organicandnatural.org.