CFSAN’s list of priorities for 2013-14, which is available in full here, has numerous issues for companies active in the dietary supplements industry, including the finalizing guidance for new dietary ingredients (NDIs), modernizing the post-market surveillance system for dietary supplements, publishing final guidance to help determine if a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement, and publishing guidance for voluntarily labeling of foods made without GMOs.
The last priority listed above, item 4.1.11, was described as “intriguing” by Loren Israelsen, UNPA President.
“If this means that FDA will now tackle the complex and emotional subject of GMO labeling, this would signal a change of thinking within FDA,” said Israelsen. “In several recent federal court cases, the judges have decided to tackle the question of what is natural rather than deferring to FDA's administrative authority. It is well known that the issue of natural v. GMO labeling is a matter of high interest and concern within the dietary supplement industry.”
Commenting on the other priorities, Israelsen said that FDA is approaching spiking and intentional adulteration in a far more focused and coordinated way than in past years.
“CFSAN's just published 2013-14 goals clearly indicate this,” he said. “Goals 1.1.10, 2.1.4 and 2.3.2 are all in service of sniffing out geographic areas where environmental contamination is high & spiking of materials is known to occur, and testing high value dietary ingredients vulnerable to gross adulteration.”
The goals highlighted by Israelsen are:
1.1.10: Increase environmental sampling and targeted surveillance to identify violative products.
2.1.4: Publish proposed rule for intentional contamination.
2.3.2: Develop a comprehensive database and related tools that will provide a new approach for creating a standardized, all-inclusive “Catalog” of foods, agrochemicals used for growing foods, food additives, food ingredients, dietary supplements and cosmetics using the FDA’s Substance Registration System
Israelsen also said that the industry will see an increase in non-targeted testing, both at the point of entry and following Section 111 GMP inspections. “This is critical,” he said.
“By developing broad analytical screening techniques, FDA will be looking for and finding active pharmaceutical ingredients and their analogs, industrial chemicals, steroids and so on.
“FDA's testing capabilities are vastly improved and more expansive than in past years. This analytical fire power will be put to work. Suppliers and brokers should know this.”
With so many priorities, Israelsen said the industry will have to see how FDA organizes its resources in the coming months. “It will be interesting.”
To read our article with responses from CRN and AHPA, please click here.