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.”
Wisconsin becomes 15th state to restrict DXM sales
Wisconsin on Wednesday became the 15th state to restrict the sale of cough/cold products containing DXM (dextromethorphan), a cough medicine that has the potential to be abused, especially among teenagers.
Teenagers younger than 18 would need a prescription to purchase a product containing DXM, the new law states.
Authored by Wis. Sen.Duey Stroebel, R-Saukville, and Wis. Rep. Jesse Kremer, R-Kewaskum, the bill passed the Assembly on a voice vote and was concurred by the Senate on a voice vote. Wisconsin Gov. Scott Walker signed the bill into law Wednesday.
While millions of Americans use products containing DXM to safely treat their cough symptoms, according to the 2017 National Institute on Drug Abuse (NIDA) annual Monitoring the Future survey, one in 30 teens abuses OTC cough medicine containing DXM to get high.
“The Consumer Healthcare Products Association thanks Gov. Walker for signing this important bill into law as well as Sen. Stroebel and Rep. Kremer for their leadership and commitment to passing legislation aimed at addressing the issue of teen OTC cough medicine abuse,” Scott Melville, CHPA president and CEO, said.
In 2012, California became the first state to prohibit sales to minors. Since then, governors from Alaska, Arizona, Delaware, Florida, Kentucky, Louisiana, New Jersey, New York, Tennessee, Virginia, Washington, Nevada, Oregon, and now Wisconsin, have all signed similar laws.
“The two most important tools in combating teen OTC cough medicine abuse are public policy efforts and education,” said Melville. “We are confident that this new law will help raise awareness about the issue with parents, while ensuring access for the millions of families who responsibly use products containing DXM to treat common cough symptoms.”
CHPA has long supported state efforts to limit teen access to DXM and has worked to increase parental and community awareness of OTC cough medicine abuse through its StopMedicineAbuse.org campaign. As part of the campaign, CHPA launched a retailer education initiative in 2017, providing educational materials to retailers in states with age-restriction laws to improve retail employees’ understanding of the new law and how to enforce it.
Study: Supplementing with NR may improve heart health
Researchers from the University of Colorado Boulder on Thursday associated the supplement nicotinomide riboside with improved heart health, suggesting that supplementing with NR mimics the health benefits of caloric restriction.
Scientists have long known that restricting calories can fend off physiological signs of aging, with studies in fruit flies, roundworms, rodents and even people showing that chronically slashing intake by about a third can reap myriad health benefits and, in some cases, extend lifespan. But from a public health perspective, that advice is impractical for many and dangerous for some.
But new research indicates that when people consume NR daily, it mimics caloric restriction, kick-starting the same key chemical pathways responsible for the health benefits associated with that. Supplementation also tends to improve blood pressure and heart health, particularly in those with mild hypertension, the study found.
“This was the first-ever study to give this novel compound to humans over a period of time,” said senior author Doug Seals, a professor and researcher in the Department of Integrative Physiology. “We found that it is well tolerated and appears to activate some of the same key biological pathways that calorie restriction does.”
For the study, published in the journal Nature Communications, Seals and lead author Chris Martens, then a postdoctoral fellow at CU Boulder, included 24 lean and healthy men and women ages 55 to 79 from the Boulder area.
Half were given a placebo for six weeks, then took a 500 mg twice-daily dose of nicotinamide riboside chloride (Niagen). The other half took NR for the first six weeks, followed by placebo.
The researchers found that 1,000 mg daily of NR boosted levels of another compound called nicotinamide adenine dinucleotide (NAD+) by 60%. NAD+ is required for activation of enzymes called sirtuins, which have been credited with the beneficial effects of calorie restriction. It’s involved in a host of metabolic actions throughout the body, but it tends to decline with age.
Research suggests that as an evolutionary survival mechanism, the body conserves NAD+ when subjected to calorie restriction. But only recently have scientists begun to explore the idea of supplementing with so-called “NAD+-precursors” like NR to promote healthy aging.
“The idea is that by supplementing older adults with NR, we are not only restoring something that is lost with aging (NAD+), but we could potentially be ramping up the activity of enzymes responsible for helping protect our bodies from stress,” Martens said.
The new study also found that in 13 participants with elevated blood pressure or stage 1 hypertension (120-139/80-89 mmHg), systolic blood pressure was about 10 points lower after supplementation. A drop of that magnitude could translate to a 25% reduction in heart attack risk.
“If this magnitude of systolic blood pressure reduction with NR supplementation is confirmed in a larger clinical trial, such an effect could have broad biomedical implications,” the authors noted.
Ultimately, the authors say, such CR-mimicking compounds could provide an additional option–alongside the dietary changes and exercise currently recommended–for people whose blood pressure is not yet high enough to warrant medication but who are still at risk for a heart attack.
They stress that the study was small and “pilot in nature.”
“We are not able to make any definitive claims that this compound is safe or going to be effective for specific segments of the population,” said Martens, now an assistant professor at the University of Delaware. “What this paper provides us with is a really good stepping stone for future work.”
Martens and Seals have applied for a grant to conduct a larger clinical trial looking specifically at the impact of NR supplementation on blood pressure and heart health. Martens is also launching a separate trial looking at the impact NR has on older adults with mild cognitive impairment, a precursor to Alzheimer’s disease.