Regulatory Focus™ > News Articles > Legislation Would Create New Registration, Warning Requirements for Supplements

Legislation Would Create New Registration, Warning Requirements for Supplements

Posted 05 August 2013 | By Alexander Gaffney, RAC 

Dietary supplements have long been held to a different, more lax standard of marketing access than their pharmaceutical counterparts, which require substantial evidence of safety and efficacy to be presented to regulators before being allowed to be marketed to US consumers. But in the wake of numerous safety scandals involving supplements-which require no premarket review by the US Food and Drug Administration (FDA) and are regulated more similarly to food products-two senators are calling for supplement companies to register their products with FDA to better keep track of the products.

Background

Walk into almost any supermarket or pharmacy in the US, and you'll find myriad choices of dietary supplements. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the products basically have to meet two standards to be a supplement:

  • They must not make any claim regarding the cure, mitigation, or alleviation of any specific disease.
  • They must contain ingredients that are naturally-not synthetically-derived (e.g. vitamins, minerals, herbs, botanicals, amino acids, dietary substances, concentrates, metabolites or extracts).

This, however, is in theory. In practice, FDA has few resources with which to investigate all but the most egregious violators of DSHEA and the Federal Food, Drug and Cosmetic Act (FD&C Act), leaving many unscrupulous manufacturers to hide unpermitted ingredients in their products.

And as some critics have alleged, this problem is exacerbated by the paucity of information given to FDA by supplement manufacturers. As FDA notes on its website, supplement manufacturers do not need FDA approval to market the supplements, do not need to provide evidence to FDA regarding the safety of their products (with the exception of new dietary ingredients, or NDIs), and do not provide FDA with the labeling on their products (through the National Institutes of Health maintains a database of many of these labels).

New Legislation to Close Loopholes

And with a steady drumbeat of warnings coming out of FDA in recent years regarding supplements peddling prohibited claims, using restricted ingredients and containing unannounced prescription drugs, there have been increasing calls for regulators to do more.

And now two legislators, Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced the Dietary Supplement Labeling Act (DSLA) which would allow the agency to start requiring companies to submit proof to support various claims.

The law would specifically amend the FD&C Act, Section 350d(a) to submit to FDA a description of all dietary supplements manufactured at each facility, a list of all ingredients within each dietary supplement, and a copy of the supplement's labeling.

Under current law (the Bioterrorism Act of 2007), such companies only need to register the supplement manufacturing facility along with a list of the products manufactured at the facility. However, this information is only transmitted to FDA periodically, and the DSLA would require companies to submit this information within 30 days of a change (i.e. a new product is manufactured, a reformulation occurs, or a product is discontinued) occurring at a facility.

Black Box for Supplements

In addition, the law calls for FDA to "compile a list of dietary supplement ingredients and proprietary blends of ingredients that [it] determines could cause potentially serious adverse events, drug interactions, or contrainidications, or potential risks to subgroups such as children and pregnant or breastfeeding women."

This process, which would be aided by the Institute of Medicine, would ultimately result in mandatory warning labels for some supplement ingredients-a sort of "black box warning" for supplements, the likes of which are currently required of some prescription medications.

FDA would also be permitted to require "substantiation" for certain claims it believes could be "misleading," though the particulars of this process-specifically aimed at the "structure and function" claims permitted of general health products-is given scarce treatment in the legislation.

The legislation was previously introduced by Durbin in 2011.


Dietary Supplement Labeling Act (DSLA)


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