Tag Archives: Scott Gottlieb

Cannabis, gavel

CBD Marketplace: How Should We Navigate It?

By Richard Blau
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Cannabis, gavel

Retired NFL player Rob Gronkowski, formerly of the New England Patriots, recently signed a deal with Abacus Health Products in Woonsocket, Rhode Island that includes buying a stake in the company and agreeing to promote its products. His decision reflects his belief that cannabidiol or “CBD” products made by the company under the brand CBDMEDIC can help others manage pain the way it has helped him.

Former world champion boxer Mike Tyson is developing a cannabis farm called “Cannabis Resort” for smokers and growers on his 40-acre land in California City. His company Tyson Holistic Holdings also owns Tyson Ranch, his own cannabis strain company and recently launched his CBD brand named CopperGel, which includes roll-on relief items.

Lifestyle maven Martha Stewart has entered into a deal with cannabis and CBD company Canopy Growth to be an adviser to the company. Her role will be to help it develop a new line of CBD-based products for both humans and animals.

Learn more about the direction of the cannabis industry at the 2019 Cannabis Quality Conference & Expo, which is co-located with the Food Safety Consortium Conference & Expo | October 1–3, 2019 | Schaumburg, IL The involvement of these and other celebrities in the emerging CBD industry signals an escalation in the evolution of cannabis as a legal consumer product. CBD products are sold today not only through licensed dispensaries and pharmacies, but also in specialty cafes, smoke shops, grocery stores and general retailers. This reflects the degree to which cannabis has become increasingly integrated into mainstream society.

Thirty-three states and the District of Columbia have legalized medical cannabis products, and 11 states plus D.C. have legalized cannabis for recreational use by adults. Affecting industries as diverse as cosmetics, food and beverage and pharmaceuticals, the exponentially expanding CBD market has generated analyses forecasting that the collective market for CBD sales in the United States will surpass $15–20 billion by 2025, according to the firms BDS Analytics, Arcview Market Research and Cowen & Co.

Cannabis, gavel
Legal Recreational Use of Cannabis: Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington, plus the District of Columbia
Illinois became the second most-populous state (after California) to legalize recreational marijuana in June
Vermont was the first state to legalize marijuana for recreational use through the legislative process. The state law allows for adults age 21 and over to grow and possess small amounts of cannabis. The sale of nonmedical cannabis is not allowed.

Yet, many government officials at the state and local levels, as well as industry members and consumers, justifiably question whether CBD products are legal. For example, in January 2019, New York City’s health department started prohibiting restaurants from adding any CBD supplement to food or drink, saying CBD was not approved by the federal government as a safe ingredient for human consumption. “The Health Department takes seriously its responsibility to protect New Yorkers’ health,” a spokeswoman said in a February 2019 email to media outlet CNBC. “Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD.”

Is CBD legal in America? The answer is: “It’s complicated.”

The Details Behind CBD, Legalization and Marketing

CBD is the acronym for cannabidiol, a chemical compound found in cannabis plants—both hemp and marijuana. Unlike the chemical compound tetrahydrocannabinol (THC), which also is found in those plants, CBD does not induce a “high.”

The main difference between marijuana and hemp is the amount of THC in the plants. If the cannabis plant contains more than 0.3% of THC, federal law defines the plant as “marijuana.” Hemp is a cannabis plant with less than 0.3% of THC. While CBD produced from hemp often is sold as an oil, it actually is a chemical compound.

The Agricultural Improvement Act of 2018 (commonly known as the “2018 Farm Bill”) removed industrial hemp and hemp-derived CBD from Schedule 1 of the Controlled Substances Act. Thus, by legalizing the production of hemp, the 2018 Farm Bill removed hemp and hemp seeds from the schedule of Controlled Substances maintained by the federal Drug Enforcement Administration (DEA). That change effectively legalized hemp-derived CBD, which contains only trace amounts of THC, subject to federal agency health and safety regulations that govern all foods, beverages, supplements and other consumer products marketed in the United States. The new law also allows for increased research and product development of CBD extracted from hemp.

Not waiting for the regulators or scientists, enthusiastic entrepreneurs have produced extraordinary growth in the creation of markets for hemp CBD oil tinctures, topical creams, edibles, pet oil tinctures, vaping-liquids and a host of other consumer products purportedly containing CBD. The increase in CBD-related medical research, as well as the decreasing stigma surrounding CBD, has led to an industry boom, enticing celebrities and generating mass market growth for CBD products and sales.

According to predictive analysis and market research company Brightfield Group, $620 million worth of CBD products were sold last year in the United States. The same research team is projecting year-over-year CBD product sales growth in the United States of 706% in 2019 to reach approximately $5 billion, and sales of $23.7 billion by 2023.

Similarly, cannabis industry research firm BDS Analytics is predicting a compound annual growth rate of 49% by 2024 for all cannabis products across all distribution channels. The industry researchers also project that the CBD market, combined with other cannabis products, will create a total U.S. market of $45 billion for cannabinoids by 2024.

Another data group, New York-based Nielsen, estimates total sales of all legalized cannabis, which includes CBD products, reached $8 billion in the United States in 2018. According to Nielsen, U.S. cannabis sales should reach $41 billion by 2025, with marijuana products accounting for $35 billion, presuming 75% of the U.S. adult population has consistent access to legal marijuana by 2025.

In this context, there was only limited surprise in the marketplace when U.S. cannabis retailer Curaleaf Holdings Inc. disclosed in March 2019 that big-box retailer CVS Health Corp. will carry its line of CBD products. CVS, which is the largest drugstore chain by total sales in the United States, already has started to sell CBD products in eight states, including creams, sprays, roll-ons, lotions and salves.

Follow the link below to access page 2 of the article, which covers Regulatory Oversight and Emerging Enforcement.

Scott Gottlieb, M.D., FDA

FDA Commissioner Scott Gottlieb Reportedly Resigning

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

The Washington Post is reporting that FDA Commissioner Scott Gottlieb, M.D. is resigning. Gottlieb had only been at this post since May 2017 but has been pushing a number of initiatives across the industries in which the FDA regulates. Within the food industry, he has been supportive of taking additional policy steps to improve food safety oversight, and last year he revealed concern over some food recall practices.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” said HHS Secretary Alex Azar in a statement. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. …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.”

According to the Post article, Gottlieb wants to spend more time with his family, as he has been commuting between Washington and his home in Connecticut on a weekly basis. The article also reports that President Trump did not want Gottlieb to leave his post.

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FDA Final Guidance Informs Companies on When to Notify Public about Food Recalls

By Food Safety Tech Staff
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FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.

In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.

“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA

In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.

Scott Gottlieb, M.D., FDA

FDA Commissioner Announces Steps To Support Produce Safety Rule

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

FDA Commissioner Scott Gottlieb, M.D., announced the next steps in their approach to implement the Produce Safety Rule that was established by FSMA. During the September 12th speech at the National Association of State Departments of Agriculture, Dr. Gottlieb outlined new measures the FDA will be taking, including compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.

According to the press release, Dr. Gottlieb also announced steps the FDA will take to “address concerns related to the complexity and feasibility of implementing standards for agricultural water.” One proposed rule concerning agricultural water compliance dates, if finalized, would extend compliance dates by up to four years for produce other than sprouts.

The press release states the reasoning behind this change is allowing the FDA to revisit those standards, ensuring they are implementable for farmers across the country. Sprouts are an exception here because of their high risk for contamination and will remain subject to original compliance dates.

The announcement also covered key changes to produce farm inspections, water testing methods and training opportunities for producers and regulators. For more information, see the press release here and the full text of Dr. Gottlieb’s speech here.

Scott Gottlieb, M.D., FDA

Scott Gottlieb Confirmed to Lead FDA

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner. The vote was 57 to 42.

Gottlieb has extensive experience in healthcare and has been outspoke about the long approval process, along with the Medicare coverage process. However, he has not been vocal about food safety issues, so his impact on the food industry remains to be seen.

He previously served as deputy commissioner for medical and scientific affairs during the George W. Bush administration and was most recently a fellow at the American Enterprise Institute, a venture fund that invests in life sciences, medical technology and healthcare services.