FDA continues crackdown on Kratom companies
The Food and Drug Administration has sent another round of warning letters to two vendors its said is marketing Kratom products with scientifically unsubstantiated claims. In particular, FDA commissioner Scott Gottlieb said the agency is concerned with companies making claims about the plant’s ability to treat opioid withdrawal and addiction, as well as other serious medical conditions.
“Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims,” Gottlieb said. “In support of the public health, we continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider. We will also continue to take action against those who put the safety of Americans at risk and who violate federal law by making unsubstantiated health claims about products that they seek to sell.”
The FDA’s efforts earned the agency praise from the Council for Responsible Nutrition.
“CRN commends the FDA’s continued actions against companies that violate federal law by making unsubstantiated disease treatment claims for products such as kratom and appreciates the agency’s commitment to public health,” CRN senior vice president of scientific and regulatory affair Duffy MacKay said. “CRN applauds FDA’s issuance of warning letters to vendors who market kratom products with scientifically unsubstantiated claims including to ‘relieve opium withdrawals.’ Consumer safety and access to safe products and ingredients are critically important to CRN. We recommend that consumers seeking treatment of an opioid use disorder or addiction talk to a qualified healthcare professional or a public health authority.”
National-scale higi study finds spike in hypertension amid guidelines change
At the recent American Heart Association Hypertension 2018 Scientific Sessions, Chicago-based population health company higi presented its analysis on a nearly 30% increase in Americans classified as having high blood pressure in the aftermath of new AHA and American College of Cardiology guidelines.
The guidelines, handed down in early 2017, classified high blood pressure as a measurement of 130/80 mmHg, a change from the previous 140/80 mmHg guidelines. In examining nearly 40 million blood pressure tests across higi’s network of more than 11,000 retail pharmacy and community-based health stations in 2017, the company found a 28.8% increase in patients with high blood pressure. This nearly doubled the rate of blood pressure nationally to 62.4% from 33.6%, higi said.
More populated, urban areas in high-income communities saw the greatest increases, according to higi’s analysis, which also found that less populated, lower-income areas still had higher incidences of high blood pressure readings.
“High blood pressure readings are widely prevalent across all population centers, impacting a diverse subset of communities and cohorts,” said higi co-founder and chief medical officer Khan Siddiqui. “While blood pressure risk may still be greatest in disadvantaged populations, occurrence is spreading to include communities deemed more healthy and with higher incomes, making prioritization and risk stratification for providers and payers more challenging.”
The new blood pressure guidelines were implemented in May 2017 by higi, which said doing so allows consumers to see how their blood pressure measures up against the new standards, and receive information about next steps based on their degree of hypertension.
Jocko Willink to keynote ECRM VMS event
ECRM’s upcoming Vitamin, Weight Management and Sports Nutrition EPPS, set to kick off Sept. 30, will feature a keynote from retired Navy SEAL and best-selling author Jocko Willink. Willink, who also has a line of supplements, will give a talk titled “Combat Leadership: Build High Performance, Winning Teams.”
The focus of his ECRM keynote will be how retailers and suppliers can lead in dynamic situations, and will take place on Sept. 30, the first day of the event, which goes until Oct. 4 in Phoenix.
Willink’s talk will be based on his experience leading SEAL Team Three’s Unit Bruiser, which became the most highly decorated special operations unit of the Iraq war. A Silver Star and Bronze Star recipient, when Willink retired from the the Navy, he co-founded Echelon Front, a leadership consulting company. Willink’s leadership principles are the subject of his New York Times best-selling book, “Extreme Ownership: How U.S. Navy SEALs Lead and Win.” His latest book, “The Dichotomy of Leadership,” is co-authored with Leif Babin and is set to be released later this month.
Willink’s line of supplements for athletes will be showcased at the ECRM event. Products include Jocko Molk protein powder, Jocko discipline Force Multiplier pre-workout, Jocko Joint Warfare for anti-inflammation and Iced Jocko White Tea.