Why Solvent Change Triggers NDI

SALT LAKE CITYFDA calls for a New Dietary Ingredient (NDI) notification when solvents other than water or aqueous ethanol are used in the manufacturing process because the agency said other solvents alter the composition of the extract in significantly different ways. Industry members have challenged this point saying advanced technology has allowed solvent use, such as supercritical fluid extraction, to leave behind no residue nor cause a change to the ingredient profile.

Mark Blumenthal, founder and executive Director, the American Botanical Council (ABC), said using carbon dioxide (CO2) during supercritical fluid extraction is safe. In fact, he said CO2 is GRAS (generally recognized as safe), which may mean FDA will not object to its use in an NDI. However, the agency said its use would require a notification, per the Draft Guidance.

During Blumenthals talk at the United Natural Products Alliances (UNPA) conference on FDAs NDI Draft Guidance, Nancy Booth from SPHERIX noted processing is being looked at with regulatory scrutiny because it could introduce elements of contamination from the environment or other areas other than the solvent. Booth said even water extraction could pose a safety hazard if a contaminant entered the mix.

Blumenthal said ABC is in the process of creating a white paper on solvents in botanicals and supplements. Of the 21 solvents covered in the white paper, 17 are listed in the FDA EAFUA (everything added to food in the United States) inventory, 21 are listed as FEMA GRAS and six have International Agency for Research on Cancer (IARC) listings.

In his presentation, Blumenthal covered a few of the solvents, including acetone, n-butoanol and butyl acetate as well as commercial solvent extraction techniques such as pressurized liquid extraction and microwave assisted extraction. His said ABC research has found most of the technologies and solvents currently used for botanicals and dietary supplements are safe, which he said is what FDA is looking for with NDI notifications.

Blumenthal said ABC research has found no deaths associated with dietary supplements in 2007 or 2008 per the American Association of Poison Control Centers. He said the one death reported in 2009 was from a cancer patient taking a number of prescription drugs as well as homeopathic product used for colon cleansing.

If solvents were harmful, we would see more adverse events," Blumenthal said. In general, dietary supplements appear to be one of the safest consumer goods."