Is the Department of Agricultural Resources regulating the retail market?
No. The Department is regulating the wholesale market only within Massachusetts and not the retail market (i.e. direct to consumer sales). The wholesale market includes the following transactions:
- Wholesale of industrial hemp from Massachusetts Grower to Massachusetts Grower
- Wholesale of industrial hemp from Massachusetts Grower to Massachusetts Processor
- Wholesale of industrial hemp from Massachusetts Processor to Massachusetts Retailer
Does a retail establishment need a license to sell hemp-derived products under M.G.L.c. 128 Sec 118?
No. The Department does not require a license for a retail establishment to sell hemp-derived products pursuant to the law.
What types of hemp-derived products can be wholesaled in Massachusetts?
- Hemp seed
- Hemp seed oil
- Hulled hemp seed
- Hemp seed powder
- Hemp protein
- Building material
- Items made from hemp fiber
- Non-food CBD products for human consumption that DO NOT make any medicinal/therapeutic claims on the label and are not marketed as a dietary supplement, unless the product has already been approved by the FDA.
- Flower/plant from a Massachusetts licensed Grower to a Massachusetts licensed Grower or Processor
What products cannot be wholesaled in Massachusetts?
- Any food product containing CBD;
- Any non-food product containing CBD derived from hemp that makes therapeutic and/or medicinal claims on the label, unless it has already been approved by the FDA;
- Any product containing CBD that is being marketed as dietary supplement, unless already approved by the FDA;
- Animal feed that contains any hemp products, including CBD1
- Unprocessed or raw plant hemp, including flower that is meant for end use by a consumer.
What types of products can be sold at a retail establishment?
As stated, the Department does not regulate the retail market. As a general matter, the same guidance pertaining to wholesale transactions in Questions #3-4 would apply for retail sales in Massachusetts.
Massachusetts Department of Public Health has posted a series of FAQs regarding CBD and hemp in Food Manufactured or Sold in Massachusetts which can be found here: https://www.mass.gov/info-details/cbd-in-food-manufactured-or-sold-in-massachusetts.
The FDA has issued guidance related to products under its jurisdiction: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
What is considered a “Non-Food CBD product”?
Examples of Non-Food CBD products include those products not intended for human consumption such as lotions. Other products like dietary supplements and cosmetics fall under FDA jurisdiction.
What qualifies as a medicinal/therapeutic claim?
Consistent with FDA definitions, such claims state that products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or are intended to affect the structure or any function of the body of man or other animals. This would include a characterization of any relationship between a substance and a disease (e.g., lung cancer or heart disease) or health-related condition (e.g., high blood pressure) or claims that describe the effect that a substance has on the structure or function of the body and do not make reference to a disease. An example of a structure/function claim is "Calcium builds strong bones.”
What is considered to be a “Food product”?
Please see DPH guidance at https://www.mass.gov/info-details/cbd-in-food-manufactured-or-sold-in-massachusetts.
Why can’t I sell my raw flower/whole plant hemp to a retail store for end use?
The Department has decided to prohibit retail sale of raw flower/whole plant hemp in light of the challenges in distinguishing between raw hemp and marijuana plant material. When testing hemp for THC content/program compliance, we are looking at an average across what may be a very large crop. We are not capturing the THC content of individual flowers which may be likely to test over 0.3% when sampled individually. Because of this, there would be no reasonable way to ensure that all hemp flower being sold at retail would comply with the THC limits. Any sale of raw flower/whole plant hemp on the retail level may be subject to inspection by law enforcement.
Can a Licensed MA Processor sell products out of state or online?
As a licensed Massachusetts Processor, if I can’t sell my products in MA, can I still produce them in MA and sell them out of state or online?
As noted, certain products are permitted to be sold in MA as described above. The Department does not regulate the retail market generally.
If you are shipping products over state lines or introducing them into interstate commerce by any means, the Department recommends that you contact FDA to understand any limitations or prohibitions that may exist.
|Date published:||October 15, 2019|