Health Benefits Claimed On Nearly 70% Of Supplements Sampled In FDA Study

Almost 70% of 2,997 dietary supplement products statistically sampled from retail, catalog and Internet sources contained statements about claimed benefits, an FDA-commissioned survey says.

Eighty percent of Internet products included claims, while 71% of catalog products and 56% of purchased products made claims, according to the "Dietary Supplement Sales Information" final report released in October.

In a study contracted by FDA's Center for Food Safety & Applied Nutrition, North Carolina-based Research Triangle Institute reported that, of those 2,068 products stating claims, the most common categories were circulatory system (21%), diet supplementation (20%), mental health (17%), energy/alertness (17%) and antioxidant (16%).

Nearly one-fourth of the catalog and purchased products asserted claims for diet supplementation, while one-fourth of Internet products made circulatory system category claims.

As part of its contract to survey dietary supplement products according to a statistical sampling plan, and to create a database on supplement products, RTI sampled supplements sold in the U.S. through retail outlets, mail order catalogs and the Internet.

RTI contracted with shoppers to purchase a total of 970 products from retail stores in New York, Massachusetts, Illinois, Missouri, Maryland, South Carolina, Florida and California. Products were purchased from a total of 100 stores, evenly split between health food and other types of stores.

Researchers selected, but did not purchase, a total of 1,020 products from mail-order catalogs and 1,007 items from 77 Internet sites.

Information collected at "point-of-sale" was entered into the Dietary Supplement Product Database. The database allows users to sort the products by sales outlet, type of ingredients and type of claims made; examine whether certain categories of products tend to make particular claims; observe whether products comply with new labeling requirements; and determine whether compliance varies by manufacturer or distributor, geographic area or product category.

In all, the database contains records of supplement label information from catalogs, Internet sites and products purchased at retail obtained from a total of 32 states, with the greatest number of records across all three sources from California (526), New York (268) and Pennsylvania (186).

RTI developed 18 claims categories and 10 ingredient type categories, including amino acids, animal products, concentrates/metabolites/constituents, herbals and botanicals, herbal and botanical extracts, minerals, teas, proteins, vitamins and other ingredients.

Overall, 42% of products with identified ingredients contain herbals and botanicals, followed by vitamins (32%) and minerals (25%). "Nearly all of the purchased products listed at least one ingredient, but 5% of catalog products and 8% of Internet products did not identify a single ingredient and did not identify the primary ingredient(s) in the name of the product," the report says.

One percent of all products made the FDA-approved calcium/osteoporosis health claim, while less than 1% included FDA-approved health claims for fiber/heart disease or folic acid/birth defects.

Most of the product information was obtained prior to March 23, the date after which supplement labels must include the term "supplement," the FDA disclaimer and the Supplement Facts box. Consequently, the FDA disclaimer appeared on only 19% of all products surveyed, most frequently on Internet sites (24%) and least frequently on catalog products (13%).

The average product cost was $17.15, and Internet products were the most expensive overall, followed by catalog items and products purchased at retail. Prices ranged from 35[cents] for a single dose of a vitamin/mineral supplement taken two or more times daily, to $335 for 1,400 g of a shark cartilage supplement, for which daily dose was not indicated.

The sales report is the second of four studies FDA is undertaking to characterize the supplement industry and the reasons consumers use dietary supplements. The first report, also prepared by RTI, examined the economic characteristics of the industry (¹ (Also see "Supplement User "Demographic" Changes Not Anticipated By DSHEA - Henney" - Pink Sheet, 10 May, 1999.)).

Two internal CFSAN studies will examine consumers' views on supplements compared to OTCs and their perceptions of claims permitted on each (² (Also see "FDA Study On Dietary Supplement Industry To Be Completed by April" - Pink Sheet, 15 Mar, 1999.)).