CRN calls on FDA for greater enforcement at the border
The Council for Responsible Nutrition on Tuesday commended a recent FDA announcement reporting an increase in scrutiny of potential unsafe, counterfeit or unapproved medicines from entering the country, but called on the agency to follow through with increased enforcement.
"Every year thousands of packages are found to contain FDA-regulated products and a surprising percentage of those products are illegal. These products come in all different shapes and forms – some with sophisticated packaging and others in nondescript plastic bags," Scott Gottlieb, commissioner FDA, noted in a blog posted last week. "They include unapproved products; counterfeit or substandard drugs; and purported dietary supplements being sold for weight loss, sexual enhancement, bodybuilding or pain relief. Many products promoted as dietary supplements contain potentially dangerous undeclared drug ingredients."
“We applaud FDA for increasing its efforts to prevent illegal drugs with hidden ingredients from entering the United States. The responsible industry has been adamant about the need for FDA to increase the effectiveness of its regulation of dietary supplements, and we have been fighting for more resources for the agency to achieve this," Steve Mister, president and CEO CRN, said. "Shifting the paradigm for how the agency screens products at international mail facilities is a positive step, but increased intelligence is only valuable if it is used appropriately."
Mister wants the increased scrutiny to result in recalls and import alerts so that business partners and recipients of these ingredients here in the U.S. can be on alert to discontinue their affiliations with potentially nefarious sources. "We also urge the agency to make public the identities of the perpetrators and to refer them for enforcement by the Department of Justice. Bad actors deserve public scrutiny and criminal prosecution, and FDA has the authority to take these actions," Mister said.
Gottlieb reported that, using a new screening device, as many as 65% of packages screened tested positive for the presence of undeclared pharmaceutical ingredients, results that were later confirmed in an FDA laboratory. While the packages were not randomly selected, many were identified beforehand as suspicious packages, that's still an alarming rate.
CRN also cautioned against taking FDA’s findings out of context and making generalizations about the dietary supplement industry as a whole. The percentage of samples that tested positive for the presence of undeclared pharmaceutical ingredients, while disturbing, is not generalizable to the mainstream dietary supplement market, Mister argued. "The agency was targeting high-risk packages at international mail facilities with additional surveillance; it specifically identified products it suspected of containing illegal ingredients, and unfortunately, in many of those packages, it found them. High-risk international mail packages are not a representative sample of the U.S. marketplace as a whole."
"Every year thousands of packages are found to contain FDA-regulated products and a surprising percentage of those products are illegal. These products come in all different shapes and forms – some with sophisticated packaging and others in nondescript plastic bags," Scott Gottlieb, commissioner FDA, noted in a blog posted last week. "They include unapproved products; counterfeit or substandard drugs; and purported dietary supplements being sold for weight loss, sexual enhancement, bodybuilding or pain relief. Many products promoted as dietary supplements contain potentially dangerous undeclared drug ingredients."
“We applaud FDA for increasing its efforts to prevent illegal drugs with hidden ingredients from entering the United States. The responsible industry has been adamant about the need for FDA to increase the effectiveness of its regulation of dietary supplements, and we have been fighting for more resources for the agency to achieve this," Steve Mister, president and CEO CRN, said. "Shifting the paradigm for how the agency screens products at international mail facilities is a positive step, but increased intelligence is only valuable if it is used appropriately."
Mister wants the increased scrutiny to result in recalls and import alerts so that business partners and recipients of these ingredients here in the U.S. can be on alert to discontinue their affiliations with potentially nefarious sources. "We also urge the agency to make public the identities of the perpetrators and to refer them for enforcement by the Department of Justice. Bad actors deserve public scrutiny and criminal prosecution, and FDA has the authority to take these actions," Mister said.
Gottlieb reported that, using a new screening device, as many as 65% of packages screened tested positive for the presence of undeclared pharmaceutical ingredients, results that were later confirmed in an FDA laboratory. While the packages were not randomly selected, many were identified beforehand as suspicious packages, that's still an alarming rate.
CRN also cautioned against taking FDA’s findings out of context and making generalizations about the dietary supplement industry as a whole. The percentage of samples that tested positive for the presence of undeclared pharmaceutical ingredients, while disturbing, is not generalizable to the mainstream dietary supplement market, Mister argued. "The agency was targeting high-risk packages at international mail facilities with additional surveillance; it specifically identified products it suspected of containing illegal ingredients, and unfortunately, in many of those packages, it found them. High-risk international mail packages are not a representative sample of the U.S. marketplace as a whole."