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FDA dietary supplement initiatives will continue after Gottlieb’s departure

Despite the recent departure of Scott Gottlieb from FDA, the dietary supplement initiatives he set in motion are expected to continue under his successor. But it remains to be seen whether any substantive changes to supplement regulations or policies will be adopted under the current interim FDA commissioner.

Gottlieb, a physician who served as commissioner of FDA for two years and left the agency in early April, was widely regarded as a competent leader who spearheaded myriad initiatives and worked collaboratively.

National media reported the 46-year-old Gottlieb wanted to spend more time with his family after commuting weekly to Washington from his home in Connecticut. Gottlieb is currently listed as a resident fellow at the American Enterprise Institute (AEI), a conservative think tank, where he focuses on pharmaceutical policy, the cost of prescription drugs, FDA and other issues.

Under Gottlieb’s tenure in recent months, the agency announced plans to strengthen its regulation of dietary supplements and examine a potential legal pathway for the use of cannabidiol (CBD) in conventional food and dietary supplements. He also recently revealed the agency’s enforcement strategy related to CBD, which is widely sold in dietary supplements, cosmetics and other products.

“For supplements, Dr. Gottlieb’s tenure represents an era of FDA-industry collaboration that has never been observed before,” said Andrew Shao, interim senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), in an email. “Under Dr. Gottlieb’s leadership, the agency recognized for the first time the importance of dietary supplements for public health and the great impact the industry has had.”

Outside the dietary supplement industry, the physician and former venture capitalist built a reputation for leading many initiatives focused on tackling high drug prices, strengthening food safety, preventing the use of e-cigarettes by minors and other public health issues.

“Commissioner Gottlieb’s resignation is a loss for the consumer products industry because he has shown a willingness to give industry guidance in areas that you often don’t see from agencies,” Raqiyyah Pippins, a lawyer in Washington with Arnold & Porter Kaye Scholer LLP, who focuses on FDA regulatory issues, said in an email.

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Coming soon to a supplement label near you

Food and dietary supplement labels will be changing right in front of consumers’ eyes. Some already are. And that’s a good thing—but brands must be ready.

In 2016, FDA announced its Final Rule requiring both the Nutrition Facts and Supplement Facts boxes on product labels get updated to reflect new scientific information and to help consumers make more informed choices. It subsequently extended the compliance deadline, mandating that most manufacturers complete these changes by January 2020, although small producers get an extra year to comply. The labels on store shelves already are changing as manufacturers begin phasing in these new requirements.

Some of these revisions were welcomed by the industry. One of the primary changes is new percent Daily Value (%DV) for some essential nutrients to replace outdated science that was 20 to 30 years old. These updated values reflect what we know now about how much average consumers need of these nutrients and what their daily diets are likely to provide. It turns out, we need more of some nutrients than previously thought and less of others.

In some cases, the new label requirements have led brands to reformulate rather than relabel. Some brands want to be able to declare 100 percent of the DV or continue to market their products as “good” or “excellent” sources of a particular nutrient (terms that are tied to the Daily Values). So rather than change labels, manufacturers chose to change ingredient levels. New formulations mean new safety analyses and new stability tests to keep the claimed percentages constant.

FDA also is mandating additional label information and changing the required vitamins and minerals that must be disclosed on the label. For example, the amount and percent Daily Value of sugars added to a product must be disclosed. Vitamins A and C will no longer be mandatory on the label, but vitamin D and potassium will be declared along with calcium and iron. Still other changes include changing units of measurement for vitamins A, D and E from International Units, or IU, to more common measures of milligrams and micrograms. And folic acid—an important nutrient before and during pregnancy—will be listed as folate and be measured in micrograms of dietary folate equivalents (DFE).

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FDA Commissioner Gottlieb resigns

FDA Commissioner Scott Gottlieb, M.D., has resigned and will leave his post next month after almost two years at the helm. The move was a surprise, given he tweeted just two months ago that rumors of his departure were not true and he was determined to lead the agency through challenging regulatory issues.

The public health agency has taken aim at the opioid crisis, teen vaping and, most recently, dietary supplement regulation.

“I want to be very clear – I’m not leaving,” he tweeted, on Jan. 3, 2019. “We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.”

However, Gottlieb tweeted this afternoon, “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump – This has been a wonderful journey and parting is very hard.”

Gottlieb only said he was leaving, effective one month from today, to spend more time with family, whom reside in Connecticut, while Gottlieb works at FDA in the Washington D.C. area. According to the Washington Post, which broke the story, White House officials assured the move was not initiated by President Trump.

In a statement released online, Department of Health and Human Services Secretary Alex Azar praised Gottlieb as a “public health leader, aggressive advocate for American patients, and passionate promoter of innovation.” Azar said he would personally miss working with Gottlieb on policy. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

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FDA official sheds light on dietary supplement working group

In December, FDA announced the formation of a working group to improve oversight of the dietary supplement industry. The industry immediately wondered about the working group’s participants and objectives, including whether it would make substantive changes affecting dietary supplements without outside input.

In an interview, an FDA official explained the internal working group is focused on improving the agency’s internal processes and procedures, and he emphasized FDA would continue to solicit input from stakeholders on substantive policy changes.

The working group is “a simple self-reflection and acknowledgement that we have an obligation as an agency to make the best use of the resources and the authorities that we have,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs.

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the “market has evolved,” and FDA must ensure it has “evolved appropriately,” Tave added in a phone interview.

He suggested it is time to examine practices and procedures that his agency established long ago. For example, Tave noted, depending on a variety of factors, a product that contains an ingredient FDA has determined doesn’t belong in dietary supplements could fall under the jurisdiction of two different entities at FDA: the Center for Food Safety and Applied Nutrition, or the Center for Drug Evaluation and Research.

“When you have these products that label themselves as dietary supplements but actually contain unlawful drug ingredients … [under the law] that takes them out of the definition of dietary supplement and takes them out of the definition of food,” Tave explained. “Within FDA operationally, that makes them drug products, so what’s happening is we’re splitting up authority internally over the commodity.”

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USDA announces time frame for adopting hemp regulations

USDA on Wednesday announced its plans to promulgate regulations in fall 2019 regarding the commercial production of industrial hemp in the United States.

Under the Agricultural Improvement Act of 2018—otherwise known as the 2018 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 plans until the agency adopts its regulations, according to USDA’s Agricultural Marketing Service in a notice to industry.

USDA will hold onto a submission if a state happens to submit a plan before the regulations are promulged. The notice proclaimed: “USDA is committed to completing its review of plans within 60 days once regulations are effective.”

At least one state acted immediately in response to the 2018 Farm Bill. The Kentucky Department of Agriculture submitted its regulatory plan for hemp production the same day President Donald Trump signed the bill.

“Kentucky is emerging as an epicenter for the American rapidly-growing hemp industry,” Ryan Quarles, Commissioner of the Kentucky Department of Agriculture, wrote in a letter to U.S. Agriculture Secretary Sonny Perdue.

For the 2019 planting season, states, tribes and institutions of higher education can continue operating under the 2014 Farm Bill, USDA said.

The 2014 Farm Bill authorized institutions of higher education and state agricultural departments to grow or cultivate industrial hemp under certain conditions. The scope of that bill—including whether it authorized commercial production and sale of hemp and hemp-based products—was long debated.

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FDA’s willingness to explore reform of DSHEA draws mixed reactions

Consumer advocates, some Democratic lawmakers and industry trade organizations reacted differently to FDA’s willingness to examine possible reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The divergent reactions reflect stark differences of opinion over the reputation of the dietary supplement industry and its 25-year-old regulatory regime.

Peter Lurie, M.D., a former FDA associate commissioner who leads the nonprofit Center for Science in the Public Interest (CSPI), described DSHEA in a statement as a “deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today.”

Industry trade groups weighed in with a radically different perspective. DSHEA offered consumers wide access to supplements while protecting the safety of the public, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“We are intrigued and enthusiastic to hear what FDA has in mind, but we will be very careful to protect that balance between access and safety,” Mister said in an interview.

FDA’s top official supported the notion that most companies in the industry are responsible. The remarks by FDA Commissioner Scott Gottlieb, M.D., also underscored the need for FDA to rigorously enforce its authority to target “bad actors” who spike products with undeclared prescription drugs or otherwise endanger the public health.

“We know that most of players in this industry act responsibly,” Gottlieb said in a statement, revealing his plans to strengthen regulation of dietary supplements. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

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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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