Call Us Toll Free (800) 688-5956

FDA to issue ‘discretion policy,’ interim rule on CBD in dietary supplements

U.S. Sen. Ron Wyden on Tuesday urged top federal health officials to announce a “formal enforcement discretion policy” by Aug. 1 regarding CBD as a food additive or dietary ingredient in supplements.

Without such a policy, “hemp producers and their customers will continue to be left in a regulatory gray zone,” Wyden, a Democrat from Oregon, wrote to the leaders of FDA and the U.S. Department of Health and Human Services (HHS).

In a letter to HHS Secretary Alex Azar and FDA Acting Commissioner Ned Sharpless, M.D., Wyden also urged FDA to publish an interim final rule to ensure CBD can be lawfully sold in food and dietary supplements, pending the agency’s publication of a final rule.

Congress in 2018 removed hemp from the federal Controlled Substances Act (CSA), but lawmakers preserved FDA’s authority to regulate cannabis-derived products.

FDA has maintained CBD cannot be lawfully added to conventional food or marketed as a dietary supplement because essentially the compound was first studied as a drug. The agency, however, has authority to create an exception, and it hosted an all-day public hearing May 31 to examine issues around its regulation of cannabis-derived products.

Wyden characterized as “fully unacceptable” a suggestion by FDA that publishing a final rule authorizing the use of hemp-derived CBD in dietary supplements could take three to five years.

“The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” the senator wrote.

Wyden also urged FDA to streamline the process for reviewing safety-related notifications for hemp-derived CBD ingredients and dedicate staff to the process.

“I feel strongly the FDA must undertake a process to make lawful a safe level for conventional foods and dietary supplements containing hemp-derived CBD,” Wyden said.

Read The Full Article HERE

FDA commissioner highlights ‘unanswered questions’ regarding safety of CBD

FDA has many “unanswered questions” when it comes to the safety of cannabidiol (CBD), a cannabis-derived compound, the agency’s top official said last week.

FDA Acting Commissioner Norman “Ned” Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements.

During a May 31 public hearing at FDA’s campus in Silver Spring, Maryland, more than 100 speakers representing myriad interests addressed CBD and THC issues, including FDA’s prospective regulation of cannabis-derived compounds.

The hearing was intended to obtain scientific data and information about the labeling, manufacturing, marketing, product quality, safety and sale of products containing cannabis or cannabis-derived compounds.

Sharpless underscored FDA has many questions about CBD that remain unanswered.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” he said.

Sharpless suggested population-based research focused on CBD was scant prior to the passage of the Agricultural Improvement Act of 2018, otherwise known as the Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).

The “lack of evidence to support CBD’s broad use in FDA regulated products—including in food and dietary supplements—has resulted in unique complexities for its regulation,” he said, “including many unanswered questions related to … safety.”

For instance, Sharpless asked a fundamental question about CBD: How much of the compound is safe to consume in a day?

“What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and also consumes some CBD oil?” Sharpless asked. “How much is too much?”

Sharpless also asked how CBD would interact with other drugs taken by a person, and he left unanswered the question of how the compound would impact the health of a pregnant women.

“What if children access CBD products like gummy edibles?” the commissioner asked. “What happens when someone chronically uses CBD for prolonged periods?”

FDA has concluded CBD and THC—the psychoactive compound responsible for the “high” from consuming marijuana—cannot be added to conventional food or marketed in a dietary supplement because the compounds were first studied as drugs. But FDA has authority to create an exception by issuing regulations, a process that could take several years.

Read The Full Article HERE

FDA urged to act swiftly to settle confusion in CBD market

“Time is of the essence.”

The statement, made by Andrew Kline of the National Cannabis Industry Association (NCIA), encapsulates the views of many people who attended a recent public hearing hosted by FDA on cannabidiol (CBD) products.

During the May 31 hearing in Silver Spring, Maryland, several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly.

“We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market,” Kline said.

FDA is mulling whether to issue regulations that would permit CBD in conventional food and dietary supplements, but its search to answer questions over safety, effectiveness and other issues could lead to a years-long proceeding.

Based on its current interpretation of federal law, FDA has opined CBD cannot be added to conventional food or marketed as a dietary supplement because, in large part, it was first studied as a drug.

“Three to five years, at a minimum for rulemaking, is too long,” Megan Olsen, assistant general counsel of the Council for Responsible Nutrition (CRN), told FDA officials during the public hearing.

The debate over safety, she added, should not hamper FDA from promulgating regulations to allow for the use of CBD in supplements.

“There is already a regulatory framework in place that is proven to ensure the safety of dietary supplements and food—one that will automatically be implemented should FDA develop a regulation permitting CBD use in food and supplements,” Olsen said.

Read The Full Article HERE

FDA official highlights noncompliance with dietary ingredient requirement, enforcement challenges

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting.

Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new dietary ingredient (NDI) into interstate commerce.

Although many companies are suspected of neglecting to comply with the notification requirement, the director of FDA’s Office of Dietary Supplement Programs (ODSP), Steven Tave, suggested his agency doesn’t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not.

Part of FDA’s challenge is the law exempted from the NDI notification (NDIN) requirement dietary ingredients marketed before Oct. 15, 1994, and those that have “been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”

Nonetheless, Tave calculated less than 25 percent of the required NDINs have been submitted to FDA. His conclusion is based, in part, on an estimated 50,000 dietary products on the market today. Tave’s figure is at the low end of FDA’s estimates of the current dietary supplement products on the market, which could number as high as 80,000.

Only 4,000 products were on the market in 1994, according to Congress’ estimates, so at least 46,000 new dietary supplement products have been introduced since 1994.

Responding to criticism that companies have failed to comply with the NDIN requirement, industry sources have pointed out many new products are exempt from the NDIN requirement because they are, for example, combinations of old ingredients grandfathered under DSHEA.

Tave acknowledged such exemptions were not subject to the NDIN requirement.

“Let’s say 90 percent of these products did not require a notification,” he said. “That still leaves 10 percent of the products that did require a notification.”

That means the distributors or manufacturers of 4,600 products were obligated to notify FDA, providing evidence that their NDI is reasonably expected to be safe. However, only about 1,100 NDINs have been submitted to FDA since the law was signed, Tave reported.

Tave noted people could “quibble with the math,” but he suggested the order of magnitude was correct.

Read The Full Article HERE

FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements

Various Dietary Supplements 2019

FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.

Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”

Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.

“While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk,” he said. “As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.”

FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.

Read The Full Article HERE

FDA dietary supplement initiatives will continue after Gottlieb’s departure

Scott Gottlieb

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.

Read The Full Article HERE

Coming soon to a supplement label near you

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).

Read The Full Article HERE

FDA Commissioner Gottlieb resigns

Link - ScottGottlieb013018--1540x800

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.”

Read The Full Article HERE

FDA official sheds light on dietary supplement working group

FDA tainted supplements 2019

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.”

Read The Full Article HERE

USDA announces time frame for adopting hemp regulations

Montana now leads country in hemp acreage

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.

Read The Full Article HERE

1 2
ncl-made-in-usa
ncl-fda
ncl-gmp-certified

For more information call (800) 688-5956 or Contact Us for a Free Quote!

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!