Proving an Old Dietary Ingredient

FDA is likely to use it GMP (good manufacturing practice) inspections to check for new dietary ingredients (NDIs) that are on the market without FDA notification, according to Joseph M. Betz, Ph.D., Director,Office of Dietary Supplements (ODS) Analytical Methods and Reference Materials Program, at the United Natural Product Alliance’s seminar on FDA’s NDI Draft Guidance. He said if a company thinks its product contains an old dietary ingredient (ODI), which does not require FDA notification, he said it better be able to prove it.

Betz said analytical methods are one way to show an ingredient that is on the market now was sold before Oct. 15, 1994, and thus, an ODI. Such tests include indenty specifications, pattern recognition and solvent tests.

Betz walked the audience through a case example of Yohimbine (Pausinystalia yohimbe). He showed how researchers compare two or more extracts to determine if they are indeed the same ingredient.

He noted that when he was in graduate school in the late 1970s and early 1980s, he took meticulous notes on different botanical lab results; he said he also had bottles of products he found on health food stores, which shows they were sold pre 1994. He made this point to show there are ways to show an ingredient is an ODI, even if that means going through the basement of a former lab student.

ODS’s Analytical Methods and Reference Materials Program was created in 2002 to support analytical methods and reference materials that verify natural ingredient identity, as well as identify and measure contaminants. The government program provides grants to fund method development. Additionally, Betz noted the National Institute of Standards and Technology (NIST) has a Dietary Supplements Laboratory Quality Assurance Program that allows manufacturers to submit products for analysis for free. NIST will then provide feedback on the blinded results, including suggestions for method optimization.