United States: Cannabis Conflicts Part II: The Problem With State And Federal Food Labelling Requirements

Illinois' "Compassionate Use of Medical Cannabis Pilot Program Act" (the "CUMCPPA") creates an entire regime of laws, regulations and procedures by which individuals and companies are building medical cannabis growing facilities and dispensaries. These locations will be certified to grow, manufacture or sell a variety of products containing cannabis to be used for medical purposes only.

The statute defines "medical cannabis infused products," including what are commonly referred to as "edibles," or food products that contain cannabis. (See 410 ILCS 130/20.) The CUMCPPA also provides a set of labelling requirements for such edibles, combining the existing Illinois Food, Drug and Cosmetics Act (specifically, § 720.40 Food), with new requirements unique to edibles, and components of the federal food labelling requirements created and enforced by the FDA.

The statute, however, contains definitions and referenced statutes that are inherently contradictory.

For example, the CUMCPPA defines "medical cannabis infused products" by using the term "food." However, dispensaries are required by the CUMCPPA to prominently label each edible with the disclaimer, "Not a Food" on the front of the package. This contradiction evidences the difficulty legislators have had in Illinois and other states with crafting a regulatory regime that tries to avoid federal jurisdiction as much as possible.

The FDA and other federal agencies have taken the position that cannabis is a controlled substance, subject to federal jurisdiction and unfit for medical or recreational purposes unless the product complies with the FDA drug approval process. The conflict among these state and federal laws begs the question as to whether or not cannabis can be a food at all. If an edible cannabis product is marketed as a food, cultivators and dispensaries will be liable for properly labelling the products to comply with FDA food labelling and manufacturing requirements, which require more information than the CUMCPPA. These requirements include a nutrition facts panel, an ingredients listing, and an allergen statement.

To further complicate the issue, the Illinois law refers directly to the federal Food, Drug and Cosmetics Act (Federal FD&CA) and the Federal Fair Packaging and Labelling Act (FFPLA). These are the two largest pieces of federal legislation governing the labelling of all food products in the United States. The Federal FD&CA created the FDA and basic food labelling requirements, while the FFPLA created the modern food label as we see it on the average grocery store shelf. So if edible cannabis products are not foods, why refer to the federal food-labelling requirements at all?

This conflict of laws impacts the entire industry. It is a well-established principle that state laws can be more restrictive than federal laws but not less restrictive. On the face of this conflict, it appears that states, including Illinois, have moved to a less restrictive approach to cannabis than federal law requires. For example, the Illinois requirements add cannabis-specific language and a "use by date," not required by federal law. However, the Illinois requirements lack the demanding specificity of the FDA requirements, the required nutrition statement, net weight statement and any mention of a specific allergen statement.

What's more, to the extent that a cannabis producing company wants to use terms like "organic," "gluten free," and others, there are federal certification programs controlled by the FDA or the USDA. Organic claims are controlled by the USDA and require an extensive and expensive certification process, enforced by inspectors and National Organic Program Certified Agents. Manufacturers of products making claims as to their gluten content must be able to ensure that their products have less than 200 ppm gluten per the FDA's recent final rule.

In the case of Illinois, there remains a very real possibility that a cannabis business may fully comply with the state law requirements and still receive a warning letter from the FDA or be subject to other federal agency actions.

Federal food labelling regulations

The FDA, the FD&CA, and the FFPLA create a regime of federal food labelling requirements that are applicable to nearly all food products manufactured, sold, imported or distributed in the United States. Illinois' state law was clearly written in such a way as to attempt to skirt these food labelling and manufacturing regulations by requiring dispensaries to market edibles with "not a food." However, where not marketed as a drug or supplement, federal regulations still apply and will require cultivators to comply with all federal food-related regulations, from labelling to manufacturing practices.

The risks and approach

All of these federal regulatory regimes carry stiff penalties for food manufacturers that fail to comply. The USDA has the power to levy fines up to $11,000 per violation for false or uncertified organic labelling. The FDA has the power to fine manufacturers for putting misbranded (missing required label content, or using inaccurate or misleading content) or adulterated (containing a contaminant, unlisted ingredient, toxin or other substance, possibly including cannabis as an unapproved ingredient) products on the market. The FDA can also detain or confiscate mislabeled or adulterated products, a process that can take significant time and resources to address. At worst, the FDA, under the Park Doctrine can seek criminal misdemeanor charges against companies, and their officers personally, for overt or intentional violations.

Operators and investors in the cannabis industry should recognize the inherent conflict present between federal regulatory and state cannabis laws, and prepare their product labelling accordingly. Spending the time and resources to get the product labelling right before going to market can avoid significant business hurdles later.

Originally published May 20, 2015

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions