FDA cracks down on tianeptine claims
The Food and Drug Administration last week issued warning letters to two companies that the agency said were illegally marketing products containing tianeptine as dietary supplements. The FDA said the companies were illegally claiming tianeptine would treat opioid use disorder, pain and anxiety, among other claims, and that the action followed reports of adverse event caused by products with the ingredient.
Scott Gottlieb, the FDA commissioner, said the letters — to Jack B Goods Outlet Store for Tianaa Red, Tianaa White and Tianna Green products, and to MA Labs for Vicaine — were part of a larger effort the agency is undertaking to focus on safety and weed out potentially harmful products making untested claims.
“The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds — often with unproven drug claims and crossing the line when it comes to what defines a dietary supplement,” Gottlieb said. “These potentially illegal activities put the entire dietary supplement industry at risk by confusing consumers, harming patients and tainting good dietary supplement products by associating them with the activities of bad actors.”
The Council for Responsible Nutrition lauded the move from the FDA.
“[The] FDA demonstrated its continued commitment to public health and the agency’s dedication to protect consumers from illegal products falsely identified and marketed as dietary supplements,” CRN senior vice president of scientific and regulatory affairs Duffy MacKay said. “Companies selling these illegal products, labeled as containing tianeptine, are in direct violation of the federal law and are putting consumers’ health at risk. FDA knows of serious adverse events associated with tianeptine, and the agency is aware that these companies selling this ingredient are making dangerous claims, such as treating opioid use disorder.”
CRN noted that it had previously alerted consumers that there is no research to support using a supplement to treat opioid addiction, and it is illegal for supplement makers to market products with such claims.
“Consumer safety and access to safe products are important to both CRN and the FDA,” MacKay said. “CRN recommends that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”
CHPA Foundation holds annual gala, adds board member
The Consumer Healthcare Products Association’s, or CHPA, Education Foundation held its third annual gala earlier in November, which was hosted by its chair Stephen Neumann.
Neumann also is the vice president of consumer insights and business intelligence at Bayer Consumer Health, and he was assisted by Anita Brikman, executive director of the CHPA Educational Foundation, and Mary Leonard, director of the CHPA Educational Foundation in his hosting duties.
“The gala is always such a great event to highlight the good work of the foundation, and we are thrilled to see participation continue to grow each year,” Neumann said. “It truly shows the level of support and dedication we have from donors across the industry.”
Highlighted throughout the night was the foundation’s work and achievements over the past year in educating consumers about the safe use, storage and disposal of over-the-counter medicines, with initiatives like the Acetaminophen Awareness Coalition’s Know Your Dose campaign and the Up and Away campaign, led by the U.S. Centers for Disease Control and Prevention and its PROTECT Initiative.
The CHPA Educational Foundation presented awards to three deserving honorees from the consumer health community:
- CVS Health received this year’s Distinguished Industry Partner of the Year Award for championing the important issue of safe medicine storage. In June, CVS Health partnered with the foundation during National Safety Month to remind customers across 8,000 of its stores about the importance of putting medicines up, away, and out of sight and reach of young children;
- The CDC Medication Safety Program won the Outstanding Community Partner of the Year Award for their ongoing leadership and commitment to keeping children safe from unintentional medication overdoses through the PROTECT Initiative and the Up and Away campaign; and
- Bayer Consumer Health’s Coppertone + BrightGuard Partnership won the Industry Leadership Award for Advancing Responsible Self-Care Award. To address the importance of sun safety, Bayer Consumer Health and its Coppertone brand partnered with BrightGuard, the first automated sunscreen dispenser company to install sunscreen dispensers across the country this summer, representing more than 375,000 sunscreen applications supplied to the public for free.
“We are thrilled to honor our award winners this year,” Brikman said. “We had spectacular partnerships to showcase through our collaborations with CVS Health and the CDC Medication Safety Program on our Up and Away program. We also had several deserving nominations for our Industry Leadership Award. There is amazing work being done to advance responsible self-care with U.S. consumers. This year, Bayer Consumer Health’s Coppertone + BrightGuard Partnership ranked highest with our judges. Congratulations to all three of our award winners!”
In addition, the organization also welcomed Tom Corley, executive vice president, chief global retail officer and president of U.S. market at Catalina, to its board of directors.
“Tom is a wonderful addition to the CHPA Educational Foundation Board of Directors,” Neumann said. “He brings a wealth of knowledge on consumer behavior in the healthcare space and strategic ideas for partnerships that will help grow the foundation’s reach and impact.”
PPOk, Ideal Protein partner on weight management program
The Pharmacy Providers of Oklahoma, or PPOk, announced a partnership with Ideal Protein that would offer a weight management program to community pharmacies.
“The program’s clinical results are outstanding, and the business model aligns with the focus of our RxSelect CPESN network, which is to provide profitable, high impact enhanced pharmacy services for patients in the community,” John Crumly, PPOk’s executive director said.
The Ideal Protein Protocol allows pharmacies to augment their income outside of medication sales, and focuses on helping patients achieve health benefits of weight loss, the companies said.
“Our combined efforts will help make Ideal Protein available to more pharmacies, and in turn align with our company mission to help as many people attain healthy and sustainable weight loss, and all of the associated health benefits,” Thomas Barus, pharmacy services at Ideal Protein, said.
The program includes weekly customer appointments and call in coaching sessions to ensure compliance and customer education, the companies said.
“We bring our expertise to their business and assist in all aspects of setting up the service in the pharmacy, and we have enjoyed helping the pharmacy bring tremendous value to their communities by providing free education, tools and support to help their patients get healthier and stay healthy,” Deborah Buchanan, national business advisor at Ideal Protein, said.
In addition, the pharmacies also will stock the necessary products and will be provided proprietary Ideal Protein tools to manage the services, the companies said.
“We all got into pharmacy to make a positive difference in our patients lives. Ideal Protein has given us another vehicle to achieve that goal,” Bill Osborn, NCPA president and PPOk member, said.