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What to Know About FDA’s Recent Statements on CBD

Last week FDA issued a public release on CBD titled, “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis derived Compounds, Including CBD.”

The FDA document does not break much new ground, though it emphasizes again FDA’s concern with the safety of CBD, some of which comes from FDA’s review of the CBD-based epilepsy drug Epidiolex. FDA does not believe it has enough information about certain aspects of CBD, such as what happens if someone takes CBD daily for sustained periods. In addition, FDA specifically identifies as a potential harm the use of CBD with alcohol because of the increased risk of sedation and drowsiness, which can lead to injuries. FDA, in addition to issuing this document, sent 15 warning letters to companies marketing CBD products that FDA views as unapproved drugs primarily because of the drug like claims made for such products.

FDA appears to be on a path toward considering a regulation to allow the marketing of CBD in conventional foods or as a dietary supplement. This approach will likely take a long time—perhaps some 2-4 years—absent legislative changes that do not appear likely in an election year. In the meantime, FDA continues to view putting into interstate commerce a food to which CBD has been added or to market CBD as or in a dietary supplement as a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Labeling and Advertising Gluten-Free Beer

In the past decade, millions of Americans have converted to gluten-free diets. Originally a practice dictated solely by the medical needs of those who suffer from celiac disease, gluten-free has entered the mainstream. This article will explore the evolving and somewhat uncertain status of labeling and advertising beer as “gluten-free.”

Read the full article, originally published in the July/August 2015 issue of The New Brewer.

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Hard Cider for Brewers

Hard cider has shown phenomenal growth in the past several years.  With rising consumer demand, more and more craft brewers are entering this rapidly expanding market. Although hard cider is typically distributed and mar­keted like a beer product, the federal gov­ernment and most states actually tax and regulate cider as a type of wine.  Brewers contemplating the production of cider ac­cordingly must carefully consider the legal issues surrounding cider production and distribution that distinguish cider from beer.  This article outlines some of the most important (though certainly not all) of these issues.

This article was originally published in the May/June 2014 issue of The New Brewer.

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FDA to Propose Rules to Address Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors

On Monday, July 29, 2013, U.S. Food and Drug Administration (FDA) will publish two proposed regulations to implement parts of the Food Safety Modernization Act (FSMA).  The proposed rules will address: (A) Foreign Supplier Verification Programs (FSVP); and (B) the accreditation of third-party auditors.  The comment period for these proposed rules runs 120 days, putting the comment deadline on or about November 26, 2013.

A.  FSVP:  In brief, the FSVP proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures equivalent to those domestically under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  These processes and procedures include reasonably appropriate risk-based preventive controls, hazard analysis and risk-based preventive controls, and standards for produce safety.  Moreover, controls should ensure the food is not adulterated or misbranded.

B.  Accreditation of Third-Party Auditors:  Under the accreditation rule, FDA will recognize accreditation bodies, which would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs.  Importers will not generally be required to obtain certifications, but in certain circumstances FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the United States that FDA has determined poses a food safety risk.  FDA may also use accreditation to determine whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.

These two new proposed rules are part of several FDA initiatives to implement the FSMA.  Previously, FDA published proposed rules for produce safety and preventative controls for human food.  The comment period for those two proposed rules ends on September 16, 2013.

In addition, FDA has three other regulations to propose in connection with FSMA:  (1) preventative controls for animal feed; (2) protection against intentional adulteration; and (3) sanitary transportation of food.

By Court order, all of FDA’s FSMA rules must be proposed by November, 30, 2013, the comment period must end by March 31, 2014, and FDA must publish all final regulations no later than June 30, 2015.

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FDA “Action Level” for Arsenic in Apple Juice

On Friday, July 12, the U.S. Food and Drug Administration (FDA) proposed a new “action level” for arsenic in apple juice.  The FDA’s Federal Register notice and other supporting documents that accompanied the announcement are linked below.

An action level generally establishes the threshold at which FDA will consider a food or food ingredient “adulterated” within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act).  For apple juice, FDA proposes a 10 parts per billion (PPB) level.  This level is considerably lower than the 23 PPB “level of concern” previously established by FDA.

The FD&C Act’s ingredient safety standards apply to all “food” – a term defined broadly in the Act to encompass all alcohol beverages.  Thus, the 10 PPB standard will be applied to apple juice used to manufacture hard cider.  As such, cider producers should review the implications of the proposed standard on their own operations and give thought to implementing procedures to comply with the 10 PPB standard in the future.

Click here to read the FDA’s notice in the Federal Register.

Click here to read the draft Guidance for Industry Arsenic in Apple Juice: Action Level.

Click here to read the draft Supporting Document for Action Level for Arsenic in Apple Juice.

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