Source: LOHAS Weekly Newsletter
Published: Wednesday, October 01, 1997

WASHINGTON—FDA’s final dietary supplement labeling regulations were published in late September, and there were few surprises. Herbal products, for example, will face some unexpected new requirements.

Most dietary supplement manufacturers contacted by Natural Business declined comment on their reception by the industry until they’ve had time to study them.

The first opportunity to do so en masse comes on Oct. 21 from the Washington, DC-based Council for Responsible Nutrition (CRN), which will hold a day-long workshop to study the regulations with FDA officials and industry counsel at the National Airport Hilton in Arlington, VA, on Oct. 21 (see Calendar, pg. 12).

“We’ll try to get some practical insight from our members to see if there are any hidden trap doors that make implementation difficult,” John Cordaro, CRN’s president and CEO, says. “We don’t really know if we are completely satisfied yet, but CRN has long advocated full nutritional labeling. We believe the consumer should have access to that information.”

Among other things, FDA regulations restrict the use of the term “high potency” and “antioxidant” and require vitamins, minerals, herbs and amino acids to be labeled as dietary supplements.

“High potency” can be used to describe a single-ingredient product only if it contains 100% or more of the ingredient’s Daily Value (DV). With a vitamin/supplement mix, for example, two-thirds of the ingredients must be present at levels of 100% DV or more to qualify. “Antioxidant” may be used in statements of nutritional support for a wide variety of substances with established antioxidant activity, the regulations say.

Labels also must indicate the supplement’s appropriate serving size or dosage and must give information about vitamin A, sodium, vitamin C, calcium and iron, among others. In all, 14 nutrients and their amounts must be described on supplement labels if they are present at “significant levels.”

Unlike food-labeling regulations, which require DVs of certain substances not present in a product to be indicated by a zero, only DVs of substances present in dietary supplements are required to be included on supplement labels.

Two surprises in the regulations greeted manufacturers of herbal supplements. Liquid herbal extracts will be required to indicate if the product is made from fresh or dried herbs, and the manufacturer must declare the solvent used to make the extract.

The cost for companies to implement the changes is expected to reach nearly $3,000 per product to cover analytical, labeling, legal and administrative costs in addition to other costs related to developing and submitting structure-function claims, if used.

“It’s the cost of doing business,” CRN’s Cordaro says. “From time to time everyone has to change their labels. We’re hopeful that, net-net, it will be a good business decision. It may even encourage more people to buy supplements.”