Regulatory Focus™ > News Articles > NIH Opens up Supplement Labels to Public Researchers, Industry

NIH Opens up Supplement Labels to Public Researchers, Industry

Posted 17 June 2013 | By Alexander Gaffney, RAC

Consumers and industry alike have long been able to look up the approved labeling for prescription medication using the US Food and Drug Administration's (FDA) Drugs@FDA online database. Starting today, the National Institutes of Health (NIH) is making the labeling for a related class of products available as well: Dietary supplements.

Background: Supplement Requirements

Drug and supplement labeling are different from one another, with the former strictly regulated directly by FDA, while the latter is more loosely regulated by the same, but technically similar to a food product. Accordingly, under the Dietary Supplement Health Education Act (DHEA) of 1994, the products must adhere to basic standards regarding the contents of the product (e.g. the presence of any known allergens), but in contrast to their pharmaceutical counterparts are not subject to premarket approval for labeling.

Under 21 CFR 101.36, dietary supplements are required to declare all nutritional information on the label, as well as the serving size, calories per serving size/container, a reference daily intake (RDI) or daily reference value (DRV), the weight of all dietary ingredients, the names of all ingredients, and other relevant information.

The section also lists aesthetic requirements about the layout of the labeling, requiring the use of a single "easy-to-read type style," a single color type on a white or neutral background, minimum spacing standards, the use of lines to separate sections from one another, and more.

While these requirements vary immensely from those intended for pharmaceutical products, the other primary difference until now had been the ease with which researchers could access information regarding both types of products. FDA's "Drugs@FDA" database permits access to labeling for tens of thousands of drug products, allowing researchers (and the media) to quickly look up information about a product.

Searchable Supplements

Supplements, however, had historically had no similar service. Until now, that is.

In a 17 June 2013 announcement, NIH said that it was launching the Dietary Supplement Label Database (DSLD) with the intent of allowing researchers, consumers and health care providers to access the ingredient lists and labels for around 17,000 different supplement products.

"This database will be of great value to many diverse groups of people, including nutrition researchers, healthcare providers, consumers, and others," said Paul Coates, director of NIH's Office of Dietary Supplements (ODS). "For example, research scientists might use the Dietary Supplement Label Database to determine total nutrient intakes from food and supplements in populations they study."

NIH explained that the database will allow anyone to conduct quick searches for ingredients, text on the label, dietary ingredients, specific products, contact information, manufacturer, and a combination of the above.

Consumers will also stand to benefit from an application known as "My Dietary Supplements" which allows them to keep track of the products they consume as well as "science-based, reliable information" on those products.

NIH: Dietary Supplement Label Database (DSLD)

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