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Final defendant pleads guilty in Hawaii liver injuries case; USPLabs to cease operations Matthew Hebert, the final defendant in the criminal case arising from a spate of liver injuries in Hawaii has pleaded guilty, according to a report in Reuters. The case involved now-defunct sports supplement manufacturer USPLabs and its OxyElite Pro product. The federal government’s case against USPlabs LLC and its co-defendants has been resolved with USPlabs agreeing to cease its business activities within 90 days of entry of the plea agreement and immediately liquidating its inventory. Read coverage: Final defendant pleads guilty in Hawaii liver injuries case→ USPLabs agrees to cease operations in plea agreement→ TOP STORY
Cancer Institute head named acting FDA chief Ned Sharpless, M.D., who is the current head of the National Cancer Institute, will be the interim head of the Food and Drug Administration when Scott Gottlieb, M.D., leaves next month. Gottlieb, whose abrupt departure announcement last week caught the industry off guard, has called Sharpless a friend to FDA and recommended that he be given the job permanently. Read more→ TOP STORY
USDA announces timeframe for adopting hemp regulations Under the new farm bill, states and Indian tribes have the option to primarily regulate the production of hemp. That’s provided USDA approves their plans. But states and Indian tribes don’t need to submit their hemp plans to USDA until the agency adopts its regulations regarding production of the crop. The agency announced last week its plans to promulgate regulations in fall 2019 regarding the commercial production of industrial hemp in the United States. The new bill solved the long debate about the legality of commercial hemp-based product by allowing farmers to grow the crop and marketers to sell the products without interference from the Drug Enforcement Administration. Read more→ TOP STORY
Forty-seven percent of consumers are familiar with CBD Nutrition Business Journal conducted what it says is one of the largest consumer studies on CBD and found that nearly half of consumers are currently familiar with this exploding supplement. However, the results also suggest that confusion is a key challenge for the industry, with the data noting that those who do know about CBD are highly likely to be confused or unaware of the science or legality behind it. Read more→ TOP STORY
FDA announces plan to modernize supplement regulation As a follow up to UNPA's Feb. 11 Member Memo, we share industry media coverage of FDA's lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, where FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency's own policies and its capacity to manage emerging risks. At the same time, FDA took action against 17 companies making illegal Alzheimer's treatment claims, and response to the announcement was mixed. The commissioner’s remarks also open the door to the industry to engage, and it should prove it is ready to do so, says NBJ Editor Rick Polito. Read coverage: FDA commissioner announces plan to modernize regulation of dietary supplements→ FDA enforcement action on Alzheimer's claims ensnares 17 companies→ FDA's willingness to explore reform of DSHEA draws mixed reactions→ Supplement industry should say yes to FDA commissioner’s invitation→ TOP STORY
Tests of CBD oils reveal three surprise chemicals, one big problem A study released last month found that samples of CBD oils from one popular manufacturer contained potentially dangerous chemicals not listed in company materials, including a synthetic cannabinoid and a chemical generally found in cough syrup. Read more→ TOP STORY
Shutdown could delay plans to block imports of fake organic products The 2018 farm bill stipulated that USDA “develop and implement regulations to reduce the amount of fake organic food being imported,” but the U.S. government shutdown is officially stalling these plans. Laura Batcha, executive director of the Organic Trade Association, believes that the shutdown will push the new USDA rules from being implemented in 2019 to 2020. Read more→ FDA supplement chief among furloughed employees in government shutdown; Industry functions on hold1/10/2019
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FDA supplement chief among furloughed employees in government shutdown; Industry functions on hold The government shutdown has affected many operations at the Food and Drug Administration, including its Office of Dietary Supplement Programs, with Steven Tave, director, among the estimated 40 percent of employees on furlough status. The federal government shutdown has thrown a wrench into the works of the agency, according to industry sources. While food safety might not be compromised, many of FDA’s more routine assignments are on hold, and it may take months to catch up. Read coverage: Nation’s dietary supplement chief among furloughed employees during government shutdown→ FDA supplement industry functions on hold during shutdown, backlog foreseen→ TOP STORY
USDA releases final GMO label disclosure specifics; reactions are mixed In its final GMO labeling rule, released Dec. 20, USDA says it will not mandate the labeling of highly refined ingredients from GMO crops if no “modified genetic material” is detectable, but it will allow manufacturers to make voluntary disclosures on products in what it says is in the interest of transparency. Industry reaction to the ruling has been mixed. The Organic Trade Association noted deep disappointment in the standard, saying that the voluntary nature of the rule keeps consumers in the dark about how their food is grown and processed. Other groups also say the rule will be confusing. Meanwhile, FoodChainID reports a record month in November for Non-GMO Project verification applications. Read coverage: Final GMO labeling rule does not require labeling of highly refined ingredients from GM crops→ National Bioengineered Food Disclosure standard→ Organic Trade Association: Deeply disappointed in the GMO labeling law→ USDA standard on bioengineered foods draws criticism, praise→ FoodChainID reports record month for non-GMO project verification→ TOP STORY
Organic Center responds to study suggesting organic farming takes environmental toll In a recently published study, Swedish scientists have revealed that the increased land needed to farm organically may be doing the planet more harm than good. The Organic Center responded to the study results, noting that misunderstandings about organic agriculture abound and can be clearly seen in a recent misleading article about the study published in US News, entitled “Organic Food Is Worse for the Climate Than Non-Organic Food.” The US News piece suggests that organic is a bigger contributor to climate change than conventional agriculture because the lower yields contribute to deforestation—a strange conviction considering that conventional agriculture, not organic, is a major contributor to deforestation, the group said. Read coverage: New study shows how organic farming takes its toll on the environment→ Organic and climate change: Look at the big picture→ |
