Burdock Lays Out Claims, Categories at SupplySide West

LAS VEGASAs companies look to ensure their marketing carries the consumer appeal they desire, they must also be sure their verbiage will classify the product in its expected regulatory category. George Burdock, Ph.D., president of the Burdock Group, spoke on Oct. 20 at SupplySide West about how FDAs definitions of different product categories specifically affect the types of claims permitted. He started out with the basics of toxicology to first help attendees understand safety can really be a matter of dosage; even water can be toxic when given in great amounts.

From there, Burdock provided a look at the lexicon of the regulator, explaining that regulations are based on intended usage instead of fanciful" or arbitrary names such as nutraceuticals and functional foods. They work in terms of drugs, food, food ingredient and dietary supplements," he said, adding the label is what drives the determination from a regulatory perspective.

He then outlined the regulatory definitions to help attendees understand the purported lines between the categories. For example, food is specifically exempt from being considered a drug, even if a therapeutic claim is made. Next, he addressed the definition of safety," which is a relative concept based on the category. While drugs, he noted, use the risk-benefit standard, foods must meet a reasonable certainty that the substance is not harmful under intended conditions of use. He added there is some distinction between food and dietary supplementswhich must reasonably be expected to be safe"though dietary supplements are technically considered foods.