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Experts Support Kratom’s Accessibility as Regulated Botanical, Senate Confirms Trump's FTC Nominees

Experts this week said FDA should treat kratom as a dietary supplement and that an outbreak of salmonella tied to kratom underscored the need for compliance with cGMPs, as well as FDA enforcement—not the scheduling of kratom as a drug under the Controlled Substances Act. Meanwhile, the U.S. Senate has confirmed President Trump's nominees to serve on the Federal Trade Commission. This week also marked the one-year anniversary of a dietary supplement product registry: the Supplement OWL.

Editor’s Note: Below is a weekly roundup of health and nutrition news.

Experts Support Kratom’s Accessibility as Regulated Botanical Amid Salmonella Outbreak

Amid an outbreak of salmonella tied to kratom, herbal experts on Wednesday said it was important to keep the botanical on the U.S. market as a dietary supplement and subject to FDA regulations.

Kratom is consumed for various purposes, experts said, including treatment of minor pain, to relieve anxiety and for respite from withdrawal symptoms associated with use of opioids. The botanical has been used for more than a century in Southeast Asia, and an estimated three to five million Americans use kratom.

Some experts fear the Drug Enforcement Administration (DEA) will schedule kratom as a controlled substance based on a recommendation by FDA, driving consumers to purchase kratom on the black market, or worse, drug addicts will return to opioids like heroin and fentanyl.

FDA already has issued an import alert on kratom, granting its field personnel authority to detain the botanical without physical examination from several firms based in Canada, Indonesia, Malaysia, the Philippines and United States. Based on scientific literature, its computational modeling and adverse effects linked to humans, FDA recently described the compounds in kratom as opioids.

“We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” FDA Commissioner Scott Gottlieb, M.D., said in a Feb. 6, 2018 statement.

Meanwhile, epidemiologic and laboratory evidence indicates kratom is linked to an outbreak of salmonella that has infected 132 people in 38 states, reported the Centers for Disease Control and Prevention (CDC). Forty percent of the infected people have been hospitalized.

The cases of salmonella contamination don’t reflect the inherent dangerousness of kratom, said Paula Brown, Ph.D., Canada research chair in Phytoanalytics and director of the Natural Health and Food Products Research Group at the British Columbia Institute of Technology. Instead, she argued the outbreak highlighted the need for quality products made under FDA manufacturing regulations for dietary supplements.

“The answer here is to clean up and regulate the marketplace,” Brown said Wednesday during a press conference, alongside three other experts who favored keeping kratom on the U.S. market as a regulated botanical, “not to flood it with substandard and adulterated products under restrictions or an outright ban.”

Brown suggested the outbreak of salmonella tied to kratom “has little to do” with the botanical itself. “Rather, it’s the result of poor … agricultural and manufacturing practices,” she said.

The outbreak, Brown added, highlighted the need to comply with cGMPs (current Good Manufacturing Practices)—FDA regulations governing herbs and other dietary supplements—and for FDA to enforce its regulations.

Michael McGuffin, president of the American Herbal Products Association (AHPA), also weighed in on kratom during the press conference. He said his organization views kratom “as just one of the many herbs or other botanicals that are allowed under U.S. law to be marketed as a dietary supplement so long as products containing kratom comply with all applicable regulations.”

FDA has identified kratom as a new dietary ingredient (NDI), subject to a notification that establishes its safety as a dietary supplement. AHPA has recommended companies seeking to market kratom submit an NDI notification to FDA that complies with the agency’s regulations, McGuffin said.

“At the same time,” he added, “we encourage FDA to treat any such kratom NDI notification exactly as it would a notification for any other new herb.”

Others spoke on the call: Oliver Grundmann, Ph.D., clinical associate professor at the University of Florida’s College of Pharmacy and Jack Henningfield, Ph.D., an adjunct professor of Behavioral Biology at John Hopkins University School of Medicine, and vice president of research, Health Policy and Abuse Liability, at PinneyAssociates, a pharmaceutical and consumer healthcare consulting firm.

Grundmann and Henningfield are among the researchers who have questioned FDA’s conclusions concerning kratom. During a press conference in March, Grundmann said there’s a critical distinction between kratom binding to opioid receptors and what happens afterwards.

Opioids, like heroin and Oxycodone, activate a signaling pathway (G protein) responsible for analgesic effects and a second signaling pathway (beta-arrestin) associated with respiratory depression, Grundmann said in a follow-up phone interview. He explained the signaling pathway responsible for respiratory depression, which increases the risk of asphyxiation from lack of breathing, is not activated by mitragynine. This is the same pathway associated with other adverse effects including constipation and development of dependence on drugs like heroin.

Henningfield is concerned that scheduling kratom as a controlled substance would exacerbate the national opioid crisis. After DEA announced its plan in 2016 to schedule kratom as a Schedule I drug, Henningfield said he and his colleagues felt the ban could lead consumers to seek kratom on the black market. They also feared opioid addicts, who turned to the botanical for relief, would go back to opioids if kratom was banned.

Kratom, Henningfield suggested, is a significantly safer substitute to opioids.

“The people [who] are using kratom in place of opioids are real people,” he said Wednesday. “If FDA and DEA ban kratom, it will be like taking away the life preservers from people who are struggling in the ocean because they were not Coast Guard-approved.” 

Senate Confirms Antitrust Lawyer Joseph Simons, Other FTC Nominees

The U.S. Senate on Thursday confirmed antitrust lawyer Joseph Simons and four others to serve on the Federal Trade Commission (FTC).

The agency, which is responsible for enforcing antitrust laws and stopping deceptive practices, has been staffed with only two commissioners for more than a year. One of them—Terrell McSweeny, a Democrat—is resigning, effective Saturday, April 28.

Simons is slated to chair the FTC.

Others confirmed Thursday by the Senate and expected to join Simons include:

  • Rohit Chopra, a senior fellow at the Consumer Federation of America (the White House said he concentrates on consumer protection issues facing young individuals and military families);
  • Noah Phillips, chief counsel to Sen. John Cornyn, a Republican from Texas currently serving as majority whip;
  • Christine Wilson, senior vice president of regulatory and international affairs at Delta Air Lines and, during the George W. Bush administration, chief of staff to FTC Chairman Timothy Muris; and
  • Rebecca Slaughter, chief counsel to Sen. Chuck Schumer, a Democrat from New York (a Yale Law School-educated attorney and former associate to the law firm Sidley Austin LLP).

“I congratulate Joe, as well as Noah, Rebecca, and Rohit on their Senate confirmations,” FTC Interim Chairman Maureen Ohlhausen said in a statement. “I look forward to welcoming them to the commission once their appointments are made final by President Trump.”

She also congratulated Wilson, who she said would occupy her seat if she is confirmed by the Senate to serve as a judge on the U.S. Court of Federal Claims.

“The FTC is a critically important agency focused on ensuring both consumer protection and fair competition in the marketplace,” Sen. John Thune (R-South Dakota), chairman of the Senate Commerce Committee, said in a statement. “I am grateful to Acting Chairman Ohlhausen and Commissioner McSweeny for their leadership over the past year, and look forward to working with the new chairman and commissioners on challenging issues such as robocalling, privacy and data security as they step into their new roles.”

Regulatory lawyers who advise dietary supplement companies on FTC issues said the environment at the commission has been more business-friendly under the Trump administration’s first year. But it remains to be seen how the new commissioners will treat dietary supplement advertising issues, said Ivan Wasserman, a partner with the law firm Amin Talati Upadhye LLP, in a recent interview.

After One Year, Dietary Supplement Product Register Contains 10,000 Labels

One year after launching a dietary supplement product registry, the Council for Responsible Nutrition disclosed its Supplement OWL (Online Wellness Library) now contains more than 10,000 labels.

The product registry was introduced on April 27, 2017. A self-regulatory initiative, the Supplement OWL is intended to provide information for regulators, retailers and industry stakeholders on the diverse and growing number of dietary supplement products in the U.S. market.

“The Supplement OWL is a clear demonstration of what can happen when industry chooses to collaborate and speak with a united voice,” said Steve Mister, president and CEO of CRN, in a statement. “We all have the same goal: consumer safety. Working together to bring the OWL to fruition, we are helping regulators keep bad actors off the market, giving retailers a new tool to curate their product offerings and underscoring our industry’s accountability to consumers.”

There is no requirement in federal law to register dietary supplements with FDA or any other third party. However, the Supplement OWL could serve as a model for an eventual mandatory requirement in the law.

“Responsible companies recognize the importance of registry participation and understand what the absence of labels suggests,” Mister added in his statement. “If a company is not willing to be transparent, it’s only natural to wonder what they’re hiding. I’m confident that as the OWL enters its second year, soon the majority of responsible industry will be represented.”

In Dealing With Powdered Caffeine, FDA Favored Guidance Over Rulemaking

FDA warned in guidance earlier this month that products containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk amounts to consumers, due to the significant health risks they pose.

Although FDA had another option—issuing a formal rule banning powdered caffeine sold in bulk amounts—it believed such action wasn’t necessary. As disclosed in a blog by attorney Riëtte van Laack of the law firm Hyman Phelps & McNamara P.C., the same day FDA published its guidance, it denied a petition filed by the Center for Science in the Public Interest (CSPI), a consumer watchdog group.

In 2014, CSPI requested a formal rule banning retail distribution of pure caffeine sold in powder form as a dietary supplement. The group also requested FDA ban pure caffeine in liquid and inhalable forms.

On April 16, 2018, FDA denied the petition, saying it wasn’t necessary to ban pure and highly concentrated powdered and liquid caffeine. The agency pointed to its guidance for the industry on highly concentrated caffeine in dietary supplements, as well as related information published for consumers and the industry.

“By publishing this guidance and communicating with industry and consumers alike, we hope to bring attention to the existing legal requirements regarding these types of products,” FDA explained it its letter to CSPI denying its petition. “We think those legal requirements are sufficient to address the serious dangers that are posed by these products. However, to the extent that experience shows that this guidance does not adequately protect the public health, we remain open to considering further options.”

FDA also denied CSPI’s requests concerning inhalable caffeine because the agency said such products are not dietary supplements.

“It is reasonable to expect that the guidance will have the effect of discouraging the marketing of highly concentrated caffeine products sold in bulk form,” van Laack concluded in her April 27, 2018 blog post. “Thus, it appears that even though FDA denied the petition, CSPI effectively got what it requested, and the agency avoided having to go through notice and comment rulemaking.”

 

TAGS: Regulatory
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