NY and IN AG urge FDA to ‘overhaul’ supplement regulations

In a letter dated May 26, NY AG Eric Schneiderman and IN AG Greg Zoeller urged Dr Stephen Ostroff, FDA’s acting commissioner, to “overhaul federal oversight of the dietary supplements industry” ​ and to “swiftly act” on the citizen petition the Organic and Natural Health Association​​ to extend the cGMPs (code 21 CFR Part 111) to raw material manufacturers.

“There’s no need to wait for Congressional action to drastically improve federal oversight of the dietary supplement industry,” ​said AG Schneiderman. “The FDA has the authority to rewrite the rules that govern the multibillion-dollar dietary supplement industry today. ​

“The health and safety of the tens of millions of Americans who take supplements every single day will continue to be jeopardized until these lax regulations are improved. 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.”​

The letter also calls on the FDA to revisit and strengthen its enforcement more broadly.

‘Disappointing’​

Commenting on the contents of the letter, which can be read HERE​​, Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association, told us: “Asking for more money for enforcement clearly shows the laws on the books work. What we’d like to see is a more robust use of the tools.”​

Steve Mister, president and CEO of the Council for Responsible Nutrition, said: “We find it disappointing the NY AG continues his misguided attack on the industry.​

“To begin with, he continues to hold out the tests he reported in February as if there is any validity to them. Experts from inside and outside the industry agree that the concept of DNA barcoding of extracts is inappropriate and misinformed. ​

“Even if the test was valid, his results are so random and all over the place that they say more about the inability of the testers than the products themselves.”​

Welcome​

On the other hand, Karen Howard, CEO and executive director of Organic & Natural Health Association, welcomed the letter.

“Organic & Natural is pleased that the Attorneys General of NY and Indiana are taking such a strong position in support of the Citizen Petition,” ​she told us. “Appropriate enforcement of cGMPs for ingredient suppliers is absolutely essential to ensuring the integrity of the supply chain. And, while we share the Attorneys’ General concerns regarding testing criteria, we want to ensure only effective and applicable technology is utilized. ​

“What we have now is a moment in time where the industry’s leaders can engage with policy makers in reasonable discussion on testing, definitions, traceability and transparency, from which rationale, meaningful, productive incremental change can be proposed and adopted for the good of the consumer. It’s complicated work, but it is work Organic & Natural embraces, including the effort to define ‘natural.’ Inaction can only lead to more charges of regulatory abuse, warranted or otherwise, and the devolving into class action chaos.”​  

‘Flaws’​

The letter outlines what the attorneys general see as four major flaws in the FDA’s cGMPs:

Ingredient suppliers: cGMPs do not cover ingredient suppliers. Many are located overseas and beyond the reach of effective enforcement actions, said the AGs.

Testing of label claims: According to the letter, cGMPS allow manufacturers to set their own label specifications and then choose their own tests for confirming label claims. The tests used by most manufacturers often cannot distinguish genuine products from chemically similar natural and synthetic compounds.

Testing for allergens: cGMPs do not require manufacturers to engage in any confirmatory testing to ensure that supplements are free of common allergens, even where products are marketed as containing no allergens (e.g. ‘gluten-free’), said the letter.

Labeling ambiguity: cGMPs fail to define key terms commonly used by manufacturers on labeling of dietary supplements, such as “extract” or “natural”.

“When consumers buy a ‘natural’ product—which typically features a root, a leaf, a flower, or a piece of bark on the label—they do not reasonably expect to receive a heavily processed chemical,” ​stated the letter.

Response​

“The request to extend GMPs to ingredient suppliers ignores the Food Safety Modernization Act of 2011,”​ said CRN’s Steve Mister. “FSMA is vastly overhauling all food ingredient suppliers, including dietary supplement ingredient suppliers.”​

Mister also disagreed with the comment about natural product consumers not expect to receive a heavily processed chemical. “I cannot believe that consumer buying vanilla extract expect to have the whole plant in the product. It’s the same for dietary supplements. These products are clearly labeled as extracts. This is not something of concern for consumers.”​

NPA’s Dr Fabricant also challenged the points made, explaining that, although not covered by DS cGMPs, the allergen issue is covered by other parts of the Food, Drug & Cosmetics Act.

“And with respect to expanding cGMPs to ingredient suppliers, I think we all know that isn’t going to happen, with the economics of this being a critical issue.” ​

Herbal supplements probe​

New York Attorney General Eric Schneiderman publicly launched his investigation on February 2 with cease and desist letters to four major retailers – GNC, Target, Walgreens, and Walmart – after DNA barcoding tests found 79% of the products tested did not contain the labeled substance or contained other non-listed ingredients.

As reported by NutraIngredients-USA in 2013​, DNA barcoding offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material. However, botanical extracts are particularly problematic because, while some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication.

GNC subsequently subjected its products to a fourth round of testing by an independent third-party laboratory and reviewed by an independent expert. GNC has shared the results of the third party tests with the AG.

This was then followed by an announcement that GNC had reached an agreement with AG Schneiderman that affirmed its Herbal Plus products meet FDA GMP requirements and thus validates their quality.

That agreement was described by Schneiderman’s office as “historic”​ as the AG’s office sees it as GNC ‘reforming its manufacturing process for herbal supplements’.