Category Archive for: Products Liability

Home / Category: Products Liability

IMG_3491

Many people have been asking about what to do if their container is too small to fit all of the required label information. Think tinctures, single-serving shots, or small edibles. Fortunately, the OLCC and OHA heard these concerns and created special rules for small containers. If your container is too small to include all required label information, you may now use additional packaging for display purposes to include this required information.

Minimum Information on Small Container

The container actually holding the marijuana item must contain:

  • Information in a minimum 8-point font, Arial, Helvetica, or Times New Roman;
  • A principal display panel containing required information (product identity, universal symbol, net weight) if required for the type of marijuana item;
  • Business or trade name and licensee or registrant number;
  • For OLCC licensees, package unique identification number;
  • For OHA registrants, batch or process lot number;
  • Concentration of THC and CBD; and
  • Required warnings.

Additional Information

All other required information must be included on:

  • a leaflet or hangtag that will accompany the marijuana item; or
  • an outer package.

If an outer package is used, all required information must be listed on the outer packaging, even if some of it has been included on the inner container.  In other words, outer packaging must have a full label.

Check back next week for more updates, including details on the registration procedure for OHA processors, what to do with unsold dispensary inventory on October 1st, and more!

Continue Reading

If you are an Oregon marijuana business owner, you will need to ensure compliance with not only new labeling rules, but also new packaging rules. The general rule to remember is that all marijuana items must comply with these packaging rules at retail sale to the end consumer. This rule applies to OLCC licensees immediately, and OHA registrants on and after October 1, 2016.

OLCC retailers and OHA-registered dispensaries will want to pay particular attention to the new packaging rules as they are ultimately responsible for ensuring that marijuana items leaving their businesses are properly packaged. With that said, any marijuana business that wants its product to be sold to consumers in their own packaging – without first being placed in “exit packaging” (which is explained below) – will also need to ensure that their products are properly packaged.

Pre-Approval

All packaging must be “pre-approved” by the OLCC. Both OLCC licensees and OHA registrants can pursue packaging pre-approval through the OLCC’s licensing portal (this is the same method used to obtain labeling pre-approval).

The OLCC will publish a list of pre-approved packaging. Any OLCC licensee or OHA registrant may use pre-approved packaging without first seeking permission from the OLCC. If you plan to use a pre-approved package from this list, be aware that:

  • the OLCC has not yet published the list;
  • once the OLCC does publish the list, there is no guarantee that the packaging you plan to use will be on the list; and
  • if you plan to use pre-approved packaging, but of a different size or color than is specified on the list, you may not use that packaging without first obtaining pre-approval from the OLCC.

General Requirements for Packaging

The general rule is that packaging used in retail sales to end consumers must:

  • protect marijuana items from contamination or exposure to toxic and harmful substances;
  • not be attractive to minors; and
  • be child-resistant.

There are three types of child-resistant packaging:

      1. Single Use. This packaging loses its child-resistance once opened; it may be used for usable marijuana (dried flower), single-serving edibles, single-serving topicals, single-serving concentrates, and single-serving extracts. singleusepackage
      2. Continual Use. This packaging maintains its child-resistance throughout the life of the marijuana item within; it may be used for usable marijuana, edibles, topicals, concentrates and extracts. continualusepackage
      3. Exit Packaging. This packaging can be used at the point of sale to enclose non-child resistant packaging. Use of exit packaging ensures that the sale to the end consumer complies with the new packaging rules. exitpackaging

For a complete list of packaging requirements and restrictions, see Oregon Administrative Rules 845-025-7000 to 845-025-7060.

Exception to the Child-Resistance Rule

Packaging does not need to be child-resistant if the product being sold is a marijuana seed or immature marijuana plant. Regardless of this exception, all packaging – including non-child resistant packaging and exit packaging – must be pre-approved by the OLCC.

Transportation Packaging

An additional rule applies to all transfers of marijuana items among OLCC licensees. In short, these transfers must use shipping containers and must be labeled with a UID tag prior to transport. For a complete list of requirements and restrictions applicable to these transfers, see Oregon Administrative Rule 845-025-7700.

For more information, please visit the OLCC’s page for packaging and labeling pre-approval. There you will find links to guides, workshop presentations, and frequently asked questions. If you have further questions, please contact one of our compliance attorneys and we will be happy to assist you with your packaging or other needs.

Tune in tomorrow for information on how small packages (e.g., 5ml plastic screw top containers) can comply with the new packaging and labeling rules.

Continue Reading

labelimage

Whether you are involved in the medical or recreational side of the Oregon cannabis industry, you will likely be required to comply with new labeling regulations on and after October 1, 2016. These regulations, contained in Oregon Administrative Rule 333-007-0010 to 333-007-0100, apply to all recreational licensees at all times during licensure, and most medical registrants. These labeling requirements do not apply to you if you are:

  • A grower providing usable marijuana or an immature plant to a patient who designated you as their grower or to the caregiver of a patient who designated you as their grower; or
  • A designated caregiver who is transferring a marijuana item to the patient who designated you as their caregiver

Generic Labels

A label that provides only the necessary information required by the rules, and no graphics, photographs, or logos, is considered a “generic” label and requires no pre-approval. You are not required to provide notice to OLCC that you will be using a generic label.

Pre-Approved Labels

All other labels require pre-approval from OLCC before they may be placed on a marijuana item. OLCC licensees and OHA registrants may submit labels for pre-approval through the OLCC’s licensing portal. Although not ideal, if you are unable to obtain pre-approval prior to October 1, 2016, you may use a generic label until you are pre-approved. Going forward, certain label information may be changed without the need for a new pre-approval. The OLCC has been working on detailing what label information this applies to (e.g. strain, net weight, test results, etc.). We will update you as we learn more.

General Requirements for Labels

A container holding a marijuana item must have a principal display panel (PDP) that provides:

  • The product’s identity;
  • The universal marijuana symbol at a minimum size of .48” x .35 inches; universalsymbol
  • If applicable, the medical grade symbol at a minimum diameter of .35 inches; and medicalsymbol
  • Net weight in US Customary and metric units.

Labels must:

Pictograms may be used in place of written label information where appropriate, such as for activation time.  activationpictogram

Specific Labeling Requirements by Product Type

Follow the links below to find administrative rules containing lists of labeling requirements for each different product type.

Prohibitions

A label may not contain any untruthful or misleading statements. These include:

  • Use of the term “organic” unless the product has been certified;
  • Claiming that the product is gluten-free, unless labeling follows FDA labeling requirements for gluten-free products; and
  • Health claims that have not been substantiated by the totality of publicly available scientific evidence, for which there is scientific agreement among experts.

A label must not be attractive to minors. This includes:

  • Brands or designs that resemble a product marketed to children;
  • Brands or designs typically marketed to children;
  • Cartoons; and
  • Images of minors.

For more information, please visit the OLCC’s page for packaging and labeling pre-approval. There you will find links to guides, workshop presentations, and frequently asked questions. If you have further questions, please contact one of our compliance attorneys and we will be happy to assist you with your labeling or other needs.

Tune in tomorrow for information on packaging requirements under the new rules.

 

Continue Reading

usda

Is there such a thing as organic marijuana? Like most things in the industry, the answer isn’t simple. Many cultivators use organic techniques. So yes, organic cannabis exists. However, can flower, concentrates, oils or edibles be marketed as organic? That answer is NO.

Federal Regulation of the Word “Organic”

Use of the word “organic” on agricultural products is regulated by the U.S. Department of Agriculture (USDA) under the Organic Food Production Act of 1990 (OFPA). Only agricultural products certified by approved agencies may be marketed as “organic”. Marijuana is considered an agricultural product under the OFPA, but the USDA will not certify marijuana as organic because the substance remains illegal under federal law.

“Organic” Marijuana Products

So where does this leave marijuana producers? Can a business name include the word “organic”? How can “organic” products be described to discerning consumers or sensitive medical patients seeking such products? Here are a few thoughts:

  • Business Name – In August 2014, the USDA issued a statement to its various certifying agencies stating that business names containing the word “organic” do not inherently constitute a false or misleading statement. Therefore, technically you can use the word “organic” in a business name BUT it may not be practical to do so (see labelling below).
  • Labelling – Remember, the key issue is to protect consumers by preventing false advertising and providing uniformity. Consequently, the USDA regulates how you can use “organic” in labeling products. There are two main product label parts: (1) the principal display panel (PDP); and (2) the information panel. The PDP portion of the package is the front, what consumers most likely see at the time of purchase. The information panel includes the list of ingredients contained in a product and other product information. We do not recommend using the term “organic” on the PDP for marijuana products. Therefore, if a business name includes “organic” it should not appear on the PDP. You may consider an assumed business name or branding product lines. However the information panel can be used to identify ingredients used in the product that have been certified organic.
  • Alternative Terms – Businesses can use other words or phrases to describe their products. Alternative terms such as “clean”, “natural”, “local”, “whole” and “sustainable” are not regulated liked the word “organic”.
  • Alternative Certification Programs – Lastly, there are alternative certification programs for the marijuana industry equivalent to organic certification. Currently two private companies have been created, Clean Green Certified and Certified Kind. Alternative certification costs approximately $1,800 to $2,000 per year. But remember, even with alternative certification, you cannot market products as “organic”.

Prior to the OFPA, organic food was regulated by the states. There were substantial differences in organic farm regulations from state to state. For example, by 1990 three states operated their own organic certification programs, four states used independent certification organizations, and fifteen states defined organic techniques but did not require certification. Organic farmers found the patchwork of state regulation to be confusing to consumers and lobbied Congress to pass federal law to provide consistent and uniform information to consumers and promote fair trade practice. My prediction is that states at the forefront of marijuana legalization will begin self-regulating, similar to the food industry. In fact, Oregon passed the nation’s first organic certification law in 1973. Maybe Oregon will lead the way again by developing marijuana industry standards.

Continue Reading