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Vanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows' full bio.

As more states legalize the recreational use of marijuana, beer servers will undoubtedly face situations in which a patron is too impaired to drive due to the consumption of both cannabis and alcohol. State laws do not provide a crosswalk of breath alcohol concentration (BrAC) limits and nanograms per milliliter (ng/ml) of delta-9-tetrahydrocannabinol (THC) in a driver’s body fluids. But a few states have established limits on the nanograms per milliliter (ng/ml) of THC that may be present in a driver’s blood or urine. States will continue to create and modify statutory and regulatory schemes focused on marijuana impairment. In doing so, state legislatures will likely revisit the policy discussions on limits for alcohol consumption.

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Originally published in The New Brewer, July/August 2018.

On Friday, April 13th, Senator Cory Gardner (R-CO) announced that President Trump assured him that the Department of Justice’s decision to rescind the Obama-era guidance on marijuana enforcement would not affect Colorado’s legal marijuana industry. President Trump also promised Senator Gardner that he would support a federal legislative fix that takes into account state decisions to legalize marijuana. In turn, the senator lifted holds on all Department of Justice nominees, ending an intra-GOP standoff over the Department’s cannabis policy.

In January, Attorney General Jeff Sessions rescinded guidance that outlined eight marijuana enforcement priorities, heightening the possibility of a federal crackdown in states that legalized recreational and medical cannabis. Pro-legalization advocates feared that Sessions’ announcement granted federal prosecutors broader discretion to pursue criminal charges against marijuana businesses operating legally under state law in states like Colorado, Washington, California and elsewhere. Sen. Gardner immediately responded that he would block all DOJ nominations over the new policy. Continue Reading President Trump Commits to Protect Colorado’s Legal Marijuana Industry

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims to assist and provide recommendations to industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notifications for firm‑initiated or FDA‑requested recalls. In addition, the guidance discusses what information to include in a public warning, as well as the parties responsible for issuing it. Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages. Comments on the draft guidance are due by March 20, 2018. Continue Reading FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

Today, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance Regarding the Ogden Memo in Jurisdictions Seeking to Authorize Marijuana for Medical Use, Guidance Regarding Marijuana Enforcement and Guidance Regarding Marijuana Related Financial Crimes. These three Obama-era guidance documents were drafted by then Deputy Attorney General James M. Cole in response to state legalization initiatives. Continue Reading Cannabis Chaos: Justice Department Revokes Obama-Era Guidance on Marijuana Enforcement

In the past three years, TTB has approved an increasing number of certificate of label approvals (“COLA”) for hemp-flavored vodka, from Mill Six’s hemp, white tea and ginger flavored vodka to Olde Imperial Mystic’s hemp infused vodka. Distillers have designed labels with green smoke-like images and psychedelic sixties-style lettering to hint at their cultural connection to marijuana. As more states have legalized recreational cannabis, distillers have been thinking more ambitiously about combining their distilling business with one or more aspects of the emerging marijuana business.

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Originally published in Artisan Spirit: Winter 2017.

It’s hard to deny that marijuana has a cultural connection with craft beer, or at least with substantial segments of the craft brewing community. Many craft brewers have signaled to their fans that they know a thing or two about the rituals and lingo of marijuana consumption. But with the legalization of recreational cannabis by several states since 2012, many brewers have been thinking more ambitiously about combining their brewing business with one or more aspects of the emerging marijuana business.

Read “Government Affairs Extra | Craft Beer and Marijuana.”

This article originally appeared in The New Brewer November/December 2017.

Two consumer advocacy groups recently sued the Food and Drug Administration (FDA) for delaying the compliance deadline for the agency’s 2014 menu labeling rule for a fourth time. The menu labeling rule requires menu items offered for sale in restaurants with 20 or more locations to disclose nutritional information and the number of calories in each standard menu item. FDA and Congress previously extended or delayed compliance with the menu labeling rule three times in 2015 and 2016. Before the latest delay, the most recent “compliance date” for the menu labeling rule was May 5, 2017.

Continue Reading FDA’s Delay of the Menu Labeling Rule Challenged

The incoming Trump Administration may usher in a more hostile climate to state efforts to legalize the sale and distribution of marijuana and products that contain the drug. The Obama Administration opposed the federal legalization of marijuana, but its enforcement approach, which focused on persons and entities whose conduct interferes with eight drug enforcement priorities, is outlined in a memorandum. This guidance does not have the force and effect of law, which means that the incoming Administration may replace it with a new guidance addressing prosecutorial discretion in marijuana cases. Below we examine the positions taken by President-elect Trump and his nominee for Attorney General, Senator Jeff Sessions, on (1) medical and recreational marijuana, (2) states’ rights, (3) attitudes toward marijuana use, and (4) enforcement of federal drug laws.

Continue Reading The Trump Administration’s View on Marijuana: Reading the (Tea) Leaves

Most breweries have numerous deal­ings with the Alcohol and Tobacco Tax and Trade Bureau (TTB) and un­derstand the need to comply with TTB regulations; this includes preparation for TTB audits and inspections. But the TTB is not the only federal agency with the authority to con­duct a brewery inspection.

The Food and Drug Administration (FDA) also inspects food facilities, including breweries, to ensure they comply with FDA regulatory require­ments. The FDA may conduct inspections as the result of routine surveillance, product quality is­sues, consumer complaints, or recalls. The agen­cy also may conduct inspections to follow up on a previous inspection or an FDA enforcement ac­tion. The FDA also contracts with state and local food protection programs to conduct inspections and provide certification and training.

Read the full article, originally published in the July/August 2016 issue of The New Brewer.

This week, the Food and Drug Administration’s (FDA) Director of the Center for Food Safety and Applied Nutrition (CFSAN) formally announced that the agency will delay enforcement of its final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” The statement marked the second time the agency extended the compliance deadline.  Enforcement of the menu labeling rule was scheduled to take effect on December 1, 2016. The date that the FDA will begin enforcing menu labeling provisions is unknown at this time. The delay is the result of a provision in a federal appropriations law that prohibits the FDA from using funds to implement, administer, or enforce the menu labeling rule until one year after the agency issues its final, Level 1 guidance on nutrition labeling of standard menu items in restaurants and similar retail food establishments. FDA has yet to issue that final guidance.