The Food and Drug Administration is being accused of ignoring calls to pull dietary supplements containing an unapproved ingredient from shelves.
Sen. Claire McCaskill, D-Mo., accused the agency of ignoring her requests to pull any supplements with picamilon, a synthetic drug made by the Soviets to combat a slew of ailments from depression to migraines. The criticism comes in the midst of growing questions about how supplements are regulated.
Related Story: http://www.washingtonexaminer.com/article/2575923
McCaskill took matters into her own hands Monday by writing 10 retailers, including Amazon, CVS and Walmart, asking them to voluntarily pull the product.
“So we’re at a point of relying on businesses to voluntarily take responsible steps to ensure public safety,” she said. “It’s embarrassing that it’s come to this.”
The FDA said that it will respond to McCaskill. It told the Washington Examiner that the agency prioritizes enforcement actions “based on available resources and the level of safety concern identified. The agency faces the challenge of having limited resources to monitor the marketplace for potentially harmful dietary supplements.”
Last month, the agency said in a legal filing that picamilon was not a dietary ingredient and therefore couldn’t be used in supplements. McCaskill wrote in her letter that she asked the agency late last month to review the ingredient and remove it from store shelves if it is not a proper dietary ingredient.
A dietary ingredient has to contain one or a combination of substances such as vitamins, minerals, herbs, an extract, amino acid or enzymes or tissues from organs or glands, according to the FDA’s website. There is an exception if the ingredient was sold in a supplement before October 1994, when the federal law went into effect.
The FDA does not approve a supplement before it hits the market but can pull it from store shelves if it believes the product is unsafe or doesn’t meet federal regulations for labeling or manufacturing. It is this step that McCaskill believes the agency is not doing enough on.
Picamilon is a synthetic drug that has been prescribed in Europe for decades. It is not approved in the U.S. But the drug has been used in supplements, and its use was only discovered in a lawsuit filed last month by Oregon against GNC. Oregon charged that the supplement and vitamin retailer was pushing supplements that contained illegal ingredients.
One such ingredient was picamilon, which the FDA said in an affidavit was not a dietary ingredient, McCaskill said.
Dietary supplement regulation operates in a bit of a gray area. Unlike drugs, the FDA is prohibited under federal law from reviewing a supplement before it hits the market.
The agency can pull a supplement from shelves, but only after it has enough evidence that the supplement is unsafe.
The supplement industry said that the agency is letting the states take the lead on the use of picamilon, when it in fact has the authority to act. The industry wants to ensure a uniform approach to the use of the supplement.
The FDA’s affidavit was dated Sept. 28, but the agency “has yet to use its enforcement power to restrict the ingredient,” according to the Natural Products Association, a supplement trade group.
“It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority,” CEO Dan Fabricant said. “If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”
Over the past year, the supplement industry has been beset by scandals of dietary supplements that had ingredients that weren’t on the label.
New York Attorney General Eric Schneiderman pulled supplements from Walmart, Target and GNC shelves after testing revealed they didn’t contain the ingredients on the label.
GNC pushed back and proved to Schneiderman’s office that its supplements had the ingredients it purported on the label.
