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Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts

Massachusetts Rep. Kay Kahn, a Democrat from the Boston suburb of Newton, refiled a bill in January that would restrict sales of certain weight loss and muscle building dietary supplements to minors, requiring retailers to post dire warnings of potential injuries and even death, as well as placing these supplements behind the counter.

Introduced in the Democrat-controlled House last week, the new bill (H.D. 2883) is unchanged from bill H.1195, which Kahn introduced in the 2017-2018 legislative session.

It would require retailers to limit access of weight loss and muscle building supplements to any consumer under the age of 18, essentially putting the products under lock and key and permitting access by store manager only.

The bill also proposes a requirement that retailers of such supplements post a warning on the counter “that certain over-the-counter diet pills, or dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death.”

The state’s Department of Public health would determine the exact warning language and partner with FDA and key stakeholders, including the eating disorder community, to determine which weight and muscle products would be restricted for sale.

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FDA commissioner announces plan to modernize regulation of dietary supplements

The head of FDA on Monday announced a goal to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”

A quarter century after Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has thrived with tens of billions of dollars in annual sales, the majority of U.S. adults taking supplements and an estimated 80,000 products on the U.S. market.

But in a lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency’s policies and capacity to manage emerging risks.

“To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” Gottlieb said. “Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.”

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FDA commissioner announces formation of dietary supplement working group

FDA’s top official on Wednesday announced the creation of a working group within his agency to improve oversight of the dietary supplement industry, reflecting concerns over FDA’s ability to manage risks in a sector that has grown 10-fold over the last quarter century.

“I’ve formed a dietary supplement working group within FDA to take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures—and what new authorities might make sense,” Gottlieb announced during a speech in Washington at the FDLI [Food and Drug Law Institute] Enforcement, Litigation and Compliance Conference. “We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements.”

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has grown from US$4 billion to more than $40 billion, with more than 50,000 products on the market, Gottlieb observed.

“And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not,” he said. “With the growth come new opportunities for consumers to improve their health, but also a lot of new risks.”

Gottlieb added, “I’m concerned that the industry has gotten bigger and riskier faster than our policies and our capacity to manage this risk. That needs to change. And so we plan on advancing new policies that will improve our oversight in this space.”

Gottlieb reported FDA’s success working with its partners at the U.S. Department of Justice (DOJ) on civil and criminal cases involving dietary supplements, an area where he said the agency has “encountered a range of problematic conduct.”

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Can the FDA really shut down the frothy CBD market?

Amid the champagne corks popping and footballs spiking as hemp becomes legalized thanks to the 2018 Farm Bill that sailed through the U.S. Congress this week, questions remain over whether the FDA will maintain its conservative interpretation of statutes and somehow reel in the booming CBD market.

The FDA, after all, was able to successfully eliminate the billion-dollar ephedra market in 2004. It also nipped in the bud the burgeoning red yeast rice market in 1998—this is the closest analogue to the CBD market today because red yeast rice contained the lovastatin molecule, which is active ingredient in the $19 billion-dollar pharmaceutical market of statin drugs. There, the FDA ruled that red yeast rice manufacturers were concentrating levels of monacolin K, which is chemically identical to the active ingredient in the cholesterol-lowering drug lovastatin. This, by law, made the supplements into illegal patented drugs.

Hemp-derived CBD players assert that they are not concentrating CBD within the hemp plant, only growing hemp plants that naturally exude high levels of CBD with less than 0.3 percent levels of THC. And that may be true. The FDA still asserts that CBD is a drug: This past June, the FDA approved GW Pharmaceuticals’ Epidiolex CBD isolate.

According to FDA, CBD was first authorized for investigation as a new pharmaceutical drug and the subject of substantial clinical investigations that have been instituted and made public. If a drug comes first, it cannot then later become a supplement. However, a supplement can then later be made into a drug, as with the Lovaza brand pharmaceutical fish oil concentrate. Pharma trumps supplements.

More to the point, the 2018 Farm Bill that just passed both houses of Congress explicitly stated that while the law will remove hemp from the Controlled Substances Act and thus remove the Drug Enforcement Agency from any regulatory action around hemp or CBD, the FDA remains the federal regulatory authority in charge of the market.

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California joins FDA in saying no to CBD in foods, supplements

A position adopted by state officials in California has drawn criticism from companies selling cannabidiol (CBD) in conventional foods and dietary supplements.

The fresh feud brewing in The Golden State symbolizes the disparate treatment of myriad cannabis products in one of the world’s largest economies. Consumers in California can legally buy marijuana for medical and recreational use, but state officials recently said CBD products are off-limits in foods and supplements.

Relying on statements by the federal agency responsible for regulating food in interstate commerce, the Food and Drug Branch of the California Department of Public Health (CDPH) asserted in a public statement, or FAQ, “[T]he use of industrial hemp as a source of CBD to be added to food products is prohibited.”

“Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive or dietary supplement,” the state agency concluded.

According to CDPH’s statement, “California incorporates federal law regarding food additives, dietary use products, food labeling and good manufacturing practices for food.” The CDPH described CBD as “an unapproved food additive” that is not permitted “for use in human and animal foods per the FDA, and thus, it is not approved in California.”

Asked for this article to explain what prompted CDPH to issue the FAQ, the agency noted, “There has been some confusion on the legal use of CBD and CBD oil since the legalization of medicinal and adult-use cannabis in California.”

In 1996, California became the first state to legalize medicinal marijuana through Proposition 215. Earlier this year, the state began permitting recreational sales of cannabis after California, Massachusetts and Nevada in 2016 joined four other states in legalizing recreational marijuana.

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FDA Approves CBD Medicine, Signals Enforcement Priorities Against Unapproved Products

FDA on Monday announced approval of a cannabidiol (CBD)-based drug derived from marijuana, and its top official signaled where the agency will focus its enforcement priorities against companies marketing unapproved CBD products.

Epidiolex, the medicine developed by GW Pharmaceuticals plc, was approved by FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients at least two years old. Many parents who have children suffering from certain forms of epilepsy have turned to CBD, but the federal government has largely considered CBD a Schedule I controlled substance, or marijuana derivative, with no acceptable medical use—until now.

Justin Gover, GW’s chief executive officer, described FDA approval of Epidiolex as “a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies.”

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” he said in a press release. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

During a conference call with reporters, Douglas Throckmorton, M.D, an FDA official, confirmed the Drug Enforcement Administration (DEA) will need to reschedule CBD into one of the schedules other than Schedule I under the Controlled Substances Act. Barbara Carreno, an DEA spokeswoman, did not immediately respond to a request for comment on the process and timing for such action, though Throckmorton said FDA wanted to get Epidiolex available to patients “as quickly as we possibly can.”

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb, M.D., said in a news release. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”

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Supreme Court Divided on Sales Taxes for Online Purchases

A closely divided Supreme Court struggled on Tuesday to decide whether internet retailers should have to collect sales taxes in states where they have no physical presence.

Brick-and-mortar businesses have long complained that they are disadvantaged by having to charge sales taxes while many of their online competitors do not. States have said that they are missing out on tens of billions of dollars in annual revenue under a 1992 Supreme Court ruling that helped spur the rise of internet shopping.

By the end of arguments on Tuesday, it was not clear whether there were five votes to overrule the 1992 decision, Quill Corporation v. North Dakota, which said the Constitution bars states from collecting sales taxes from companies that do not have a substantial connection to the state.

Several justices expressed concerns about imposing crushing burdens on small businesses that sell goods on the internet and about making them liable for back taxes. Justice Sonia Sotomayor said the case before the court, South Dakota v. Wayfair, No. 17-494, raised “a host of questions” and “a whole new set of difficulties.”

Sounding almost plaintive, she added that Congress, rather than the Supreme Court, was the right forum in which to settle the matter.

“Is there anything we can do to give Congress a signal that it should act more affirmatively in this area?” Justice Sotomayor asked.

But Chief Justice John G. Roberts Jr. said that “it would be very strange for us to tell Congress it ought to do something in any particular area.”

Both he and Justice Elena Kagan said the fact that Congress has so far chosen not to act was itself a telling indication that it was satisfied with the current system.

The chief justice added that the marketplace may already be addressing the problem.

“The bigger e-commerce companies find themselves with a physical presence in all 50 states,” he said, “so they’re already covered.”

The tenor of the argument was a surprise, as three members of the Supreme Court had indicated that they may be ready to reconsider the Quill decision. Justices Clarence Thomas and Neil M. Gorsuch havewritten about their uneasiness with the ruling and the constitutional justifications for it.

Justice Gorsuch seemed prepared on Tuesday to reconsider the Quill decision. “Why should this court favor a particular business model?” he asked.

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