The actions of New York Attorney General Eric Schneiderman created a hothouse environment a couple of years ago, the kind in which new initiatives that meet industry needs can quickly grow and flourish. Thus it was that a decade-old AHPA document—its Good Collections Practices publication—was picked up by GNC and became the basis for it Botanical GMPs effort that AHPA has helped to coordinate.
“We started this more than a decade ago. We thought it was important at that time to bring something specific to the needs of manufacturers in the US,” said Michael McGuffin, president of AHPA. “A couple of years ago we pulled that back out of the box and extended it to include a focus on good manufacturing practice on the ingredient side.”
McGuffin said the impetus was not only because of the atmosphere of increased scrutiny that industry found itself in. The time had also come to address significant changes in the regulatory landscape, the most challenging of which is the Food Safety Modernization Act (FSMA). This is characterized as the most profound change in food law in the United States since the inception of the Food Drug and Cosmetic Act of 1938. It will profoundly affect dietary ingredient suppliers who up to now have been exempt from Part 111 requirements that apply to dietary supplement manufacturers.
“We also saw that the rules were changing with implementation of the Food Safety Modernization Act. All of the sudden the Food and Drug Administration can come onto your farm, and that is an all new idea,” he said.
The botanical GMPs document grew into a hefty tomb, more than 100 pages in all. McGuffin said AHPA intends to keep the document in an active state. In trying to answer the question of
‘what does this mean for me?’ McGuffin said the document has been broken down into its constituent parts that are relevant to agricultural operations, manufacturers, etc.
A copy of the document can be viewed here.
