The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements.

Background

In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance.

Despite commonly being used to support consumer health, dietary supplements are regulated very differently than pharmaceutical and biotechnology products. Instead of being regulated as drug products, which are intended to treat or cure diseases, they are treated more similarly to food products intended to supplement diets or nutrition.

As a result, supplement manufacturers are restricted in the claims they can make about a product. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), companies may not market a supplement as being effective against a specific disease or condition.

As food products, however, supplements are subject to less regulatory oversight than traditional pharmaceutical products. With the exception of New Dietary Ingredients (NDIs), most supplement products do not require FDA approval prior to being marketed.

Even still, supplements are not completely exempt from regulatory oversight. Under a 2007 regulation, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (21 CFR Part 111), FDA exercises its control over the methods used to manufacture dietary supplement products. This is meant to ensure supplements are manufactured to specified quality standards. For example, products should be free from contamination, companies should have processes in place to handle consumer complaints, the facility should be free of certain problems (like pest infestations), and there should be records of all products tested and produced at a facility.

AG Investigation

But a recent investigation by New York Attorney General (AG) Eric Schneiderman into the dietary supplement industry has called into question the effectiveness of FDA's dietary supplement oversight, as well as the quality of some of the biggest dietary supplement manufacturers' products.

According to Scheniderman, tests of store-brand supplements manufactured by GNC, Target, Walgreens and Walmart found that many products did not contain the ingredients on the label, and that "most" products contained "contaminants not identified on ingredient labels."

The dietary supplement industry was quick to take issue with the method of testing used in Schneiderman's investigation, known as DNA barcoding. “Anyone who knows anything about how these tests were conducted knows that the results are going to be fatally flawed,” said Corey Hilmas, the former chief of the Dietary Supplement Regulation Implementation Branch at FDA, in a statement by the Natural Products Association (NPA). The group has argued the process used to manufacture many of the tested supplements would have denatured the DNA in the products, rendering the DNA barcoding test useless.

But according to Schneiderman, the tests—the complete details of which have not yet been made public—indicate that stronger safeguards are needed to protect consumers against substandard supplements. “When consumers take an herbal supplement, they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity,” said Schneiderman in a statement.

AGs to FDA: Take Action

Now Schneiderman is taking his case to the FDA.

In a letter sent to Acting FDA Commissioner Stephen Ostroff on 2 June 2015, Schneiderman and Indiana AG Greg Zoeller argue the agency's current oversight of the supplement industry is 'jeopardizing' the health of US consumers.

"The quality control and safety issues facing the dietary supplements industry are a matter of grave public concern," the attorneys write in their letter.

“I urge the FDA to use every tool at its disposal to protect consumers in New York and across the country from the unnecessary risk of tainted supplements," Schneiderman said in an accompanying statement.

Schneiderman and Zoeller's letter goes on to argue for four reforms to FDA's cGMP regulations for dietary supplements:

1. Broadening the cGMP regulations to cover dietary ingredient suppliers, which the letter notes play a key role in the production of supplement products.
2. Enhancing requirements for testing. The letter explains that "tests used by most manufacturers often cannot distinguish genuine products from chemically similar natural and synthetic compounds." FDA should require a combination of testing methods, the letter states.
3. Allergen testing should be required "to ensure that supplements are free of common allergens."
4. FDA should define "key terms commonly used by manufacturers on labeling of dietary supplements," including "extract" and "natural."

"We tremendously appreciate the assistance of FDA in our ongoing efforts to rein in abuses in the dietary supplement industry," the letter concludes. "To address the fundamental problems affecting the national supplement market, however, federal leadership and oversight are needed urgently."

The letter follows a similar plea for congressional action sent by the AGs in April 2015.

Letter to FDA