Download the NYCGPA Official Comments on DOH Hemp Rules here.

The New York State Cannabis Growers and Processors Association, Inc. (“NYCGPA”) appreciates the work by the New York State Department of Health (“DOH”) on the Proposed Regulations concerning the processing, manufacturing, and retail sale of cannabinoid hemp products (the “Proposed  Regulations”). However, the Proposed Regulations create unnecessary challenges and issues for companies across the supply chain. Unfortunately, aspects of the regulations harm key interests within the industry without a justifiable public health argument.

Growers and processors entered the industry based on statements and expectations of support set by New York State. Part of soliciting farmers in 2015 to join the New York State Industrial Hemp Pilot Program, involved “creating new jobs and laying the foundation for future economic growth” (See September 20, 2017 Press Release — Governor Cuomo described the intention of the regulations in supportive terms: “These regulations are the next step toward regulating the growing hemp industry in New York in a way that protects consumers and helps ensure the industry’s long-term viability. Establishing the State’s Cannabinoid Hemp Program to regulate production and sale of hemp and hemp extract will help protect both consumers and farmers.” (See October 28, 2020 Press Release –

While the NYCGPA supports a safe and well-regulated hemp industry, portions of the regulations can better balance costs and benefits. The comments below specifically address key areas that the NYCGPA would like revised in the regulations to achieve the dual goals of protecting consumers while promoting the possibilities the hemp industry.



The Proposed Regulations significantly limit the types of cannabinoid hemp products permitted for sale at retail. The ability for farmers to access multiple streams of commerce for the products that they grow provides a key mechanism to diversify income streams in an already tight margined business. The Department of Agriculture and Markets realizes the importance of providing farmers this opportunity, stating as part of its core mission to “connect the New York’s farmers to new markets to grow the agricultural economy.” (See About Us — New York State’s proposal for an all-out ban on flower sales presents a serious threat to the success of the fledgling New York hemp industry and will be detrimental to farmers.

Hemp flower is among the most popular and fastest growing segments of the CBD market, and the prohibition cuts off the only practical and lucrative avenue for growers. By preventing retailers from carrying hemp flower, farmers must rely on selling directly to processors at a significantly reduced per pound basis than if they sold flower.

In order to make hemp farming profitable, hemp farmers must sell their high-end smokable flower at several hundred dollars per pound versus selling biomass for cannabinoid extraction at a loss due to oversupply and lack of federal regulation. The price per pound of hemp plummeted to less than $4.00 currently from a high of $40.00 as recently as summer 2019. According to data collected by Hemp Benchmarks, as of July the price for a pound of smokable hemp flower was nearly 20 times that of a pound of hemp biomass, assuming a CBD potency of 10% for the latter. With rates for hemp biomass eroding dramatically and fewer processors willing to pay cash for such raw material, smokable hemp flower has become a more prevalent production target among growers seeking higher commodity prices. The effective flower ban in the marketplace creates a significant economic strain on small farms that want to realize the full economic benefits of selling hemp.



These amendments alter Parts 1005.3 and 1005.8 to Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, regulating the processing and retail sale of cannabinoid hemp in New York State.

In order for farmers to sell directly to retailers we suggest the following change(s) (including the deletion of transdermal patch that is discussed further below):

  • Section 1005.8 outlines the cannabinoid hemp product requirements to be sold at retail. Product requirements include but are not limited to: not containing more than 0.3% total Δ9- Tetrahydrocannabinol concentration; not containing tobacco or alcohol; not being in the form of an injectable, transdermal patch, inhaler, suppository, flower product including cigarette, cigar or  pre-roll, or any other disallowed form as determined by the department; if sold as a food or beverage product, not have more than 25mg of cannabinoids per product; and, if sold as an inhalable cannabinoid hemp product, a number of additional safety measures.
  • Section 1005.3 Application for Cannabinoid Hemp Retail License.
    • (b) An application for licensure shall be submitted to the department on a form prescribed by the department, which shall include the following: . . .
      • (8) a statement that the applicant will not distribute or sell any cannabinoid hemp product in the form of an injectable, transdermal patch, inhaler, suppository, flower product including cigarette,  cigar, pre-roll or any other disallowed form as determined by the department;
  • Section 1005.8 Cannabinoid hemp product requirements
    • (a) All cannabinoid hemp products distributed or offered for retail sale in New York State shall: . . .
      • (5) not be in the form of an injectable, transdermal patch, inhaler, suppository, flower product including cigarette, cigar or pre-roll, or any other disallowed form as determined by the department;

As permitted by § 506(1) of Article 29, Growth, sale, distribution, transportation and processing of hemp and products derived from such hemp permitted, the statute opens the door for treating hemp as an agricultural product and does not restrict the type of sales permitted.¹ Furthermore, Article 33-B, in no way limits the sale of flower. The NYCGPA suggests that the Proposed Regulations allow retailers with a Cannabinoid Hemp Retail License to retail flower for sale.



In justifying the actions involving flower, State officials stated it was “In line with the Department of Health’s efforts to reduce tobacco and smoking consumption for all New Yorkers”, and that banning hemp flower will “discourage the use of this product form due to the negative health effects associated with combustible products.” On top of a lack of credible evidence to suggest smoking hemp harms public health, we know that prohibition in any form rarely leads to a decrease in use. In fact, consumer data suggests that banning hemp flower would likely increase tobacco use and move flower sales to the illicit market with no regulatory oversight.

A recent survey by Nielsen found that one in four tobacco smokers have consumed hemp flower, while being three times more likely than the general population to purchase the product. Whether this is due to familiarity of consuming the plant in its unprocessed form, accessible price point (on average one third the price of CBD oil), or the fact inhalation allows for the highest amount of absorption into the body, tobacco smokers are now spending on average $88.00 a year on hemp flower products. These consumers will most likely shift spending patterns back to tobacco products, which leads to 480,000 American deaths annually.

The prohibitive stance against hemp flower undermines the purported mission of the state to ensure that New Yorkers purchase tested, labeled, and quality-controlled hemp products. Ironically, many flower consumers will look toward the illicit market with uncertain THC levels without concomitant testing results. The DOH rightfully took a harm reduction strategy with hemp vaping products and should do so with flower. In fact, ensuring quality on unprocessed flower can utilize the approaches for other manufactured products.



The DOH regulations attempt to create a system allowing for the use of hemp-derived cannabinoids in certain foods, beverages, topicals, and dietary supplements. The required testing and labeling regulations can also apply to the sale of flower in permitted retailers. All cannabinoid hemp products must be manufactured using good practices based on the end product’s intended use. The label must contain the total number of cannabinoids in the product and per serving, a nutritional or supplement fact panel, information about whether the product contains THC, and appropriate warnings. Additionally, cannabinoid hemp products are required to be laboratory-tested before entering the market. The testing must cover the product’s cannabinoid profile, as well as screen for heavy metals, microbial impurities, mycotoxins, pesticides, and residual solvents (if necessary). This information must be accessible by the consumer in the form of a QR code or corresponding link on the product label. These regulations can apply to hemp flower and the DOH can easily limit flower sales to permitted retailers.

As discussed, the ban on flower will likely drive smokable hemp flower onto the illicit market. This will eliminate any tax benefits from flower sales that could have assisted New York State during a challenging time for its economy. Most importantly, consumers of hemp from the illicit market would not be afforded the protections provided when products are regulated strictly for quality control—the same protections mandated by New York for other hemp products.



One of the more concerning parts of Section 1005.8, Cannabinoid hemp products requirements, is the idea that the DOH will be able to impose a total THC cap in either milligrams per serving or per package based on the product or size of package. The cap chosen by the DOH could have a significant impact on the hemp marketplace and require the reformulation of otherwise legal cannabinoid hemp products. From a legal or safety perspective, the NYCGPA seriously questions why the DOH would reserve the future right to set a lower threshold of THC than the federal government, especially at a time of reasonable debate at the federal level to raise the THC limit in hemp to 1%, similar to other countries. In establishing its standards, the federal government realized that the THC content of cannabinoid hemp products that meet the 0.3% limit per serving would not be misused for its THC content or pose serious health risks to consumers. Further, consumers do not seek out hemp food and dietary supplements for THC content since access to THC is both easier and cheaper on the illicit and medical markets. From our research, the NYCGPA could not locate one reported incident in the state over the last three years to the contrary.


These amendments remove language from Part 1005.8(a)(2) to Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York, regulating the processing and retail sale of cannabinoid hemp in New York State.

Section 1005.8 (a)(2) should be removed or at least modified (added language in red):

  • (2) contain no more than three-tenths of a percent (0.3%) total Δ9-Tetrahydrocannabinol concentration per serving. The department shall have the ability to impose a total Δ9-Tetrahydrocannabinol cap in milligrams per serving and milligrams per package for cannabinoid hemp products based on the product form, volume, number of servings, and ratio of CBD to THC;



The NYCGPA agrees and applauds the path to complete and concise labeling standards that will set New York State products apart in quality and transparency, especially without guidance on hemp extracts from the United States Food and Drug Association (FDA). The anticipation of high standards by the FDA will hopefully allow New York growers and processors an opportunity to enter the national market with an advantage. Even without FDA guidance, New York companies can use the requirements as a way to distinguish their products in an already crowded market. However, the labeling requirements create unnecessary hurdles for companies and overburdensome requirements that will do the exact opposite. New York products will become sidelined as a result of impossible labeling that will nullify brand identities and spirit. This section will address the following areas involving labeling:

  1. Adding THC content to the labeling
  2. Listing cannabinoids in full spectrum products that are above 0.05% threshold
  3. THC warning on the labels should be deleted – Subsection (a)(f)(2)
  4. Remove Font size on labeling
  5. Best By date instead of Expiration Date
  6. 20% margin for testing and labeling for Supplements and Food Products
  7. Additional statements
  8. Marketing to minors


  1. Adding THC Content to Labeling (Section 1005.9 (a)(1)(i))

The NYCGPA does not believe that adding the amount of THC to the labels of finished products serves any real purpose and would create significant confusion for consumers, as well as not comporting with general FDA labeling requirements. Consumers look to the supplemental panel to provide the major cannabinoids in the products as it pertains to serving and total cannabinoids in the product. For example, for a full spectrum CBD based tincture the labeling must include CBD per serving, (e.g., 20mg per ml), providing clear and consistent messaging to consumers.


  • (i) a list of all ingredients in descending order of predominance by weight in the product, including but not limited to total Δ9-Tetrahydrocannabinol concentration, CBD and any other cannabinoids over 0.05%; and the cannabinoid in the highest concentration in the product
  • (ii) the number of servings per package or container, including the amount of measurable cannabinoids in milligrams per serving of the single cannabinoid that is in the highest concentration and the total major cannabinoid content of the package. If applicable, the amount of total Δ9-Tetrahydrocannabinol in milligrams per serving and milligrams per package shall be stated on the label;


  1. Listing Cannabinoids Above 0.05% (Section 1005.9 (a)(1)(i) and (ii))

The requirement to list all cannabinoids over 0.05% is problematic and unnecessary for a variety of reasons. From a consumer safety and knowledge perspective, 0.05% of cannabinoids is so minute that they will not have any effect in the final product. For example, on 20mg in 1ml of CBD full spectrum tincture there can be 0.05% of CBG. That equates to .5 MG of CBG per serving. On its own that trace amount of a minor cannabinoid is not significant when a consumer will be deciding what product to take or what serving size. If anything, it will only confuse consumers as the labels will have to be packed with so much information, especially on a “Full Spectrum” product that consumers could be confused as to what they are purchasing.

Moreover, labels on finished products would not be able to fit all of the information that would be required if products had to list each cannabinoid. Every company selling hemp products in New York and from out-of-state would need to completely redesign all packaging and every hemp retailer in New York would have to expand the amount of shelf space they devote to hemp products simply to fit larger packaging. Not only is this financially burdensome but it is also environmentally wasteful with more waste products in landfills. Most companies in Consumer-Packaged Goods minimize packaging with the goal of reducing their environmental footprint.

New York is trying to promote small craft companies as part of our growing hemp extract industry and this requirement hurts any small business that makes small batch products. Since minor cannabinoids can vary from batch to batch, especially on full and broad spectrum products, small companies would be required to print packaging in very small quantities increasing costs. In many cases packaging is more expensive than the actual product and forcing small businesses to keep printing packaging could dissuade them from doing business in New York. Most packaging companies also have large minimums for printing, in the thousands per unit, but many small businesses make batches in the hundreds. This disconnection of batch, labeling requirements and packaging would force many companies to generate unnecessary waste leading to lost revenue.

Importantly, the required QR code that leads to a third-party test per batch carries sufficient information for consumers if they want to see the variety of minor cannabinoids and terpenes in the product.


The NYCGPA recommends modifying the language so that only the single major cannabinoid is listed both per serving and per package. This will reduce consumer confusion and create reasonable packaging requirements. Section 1005.9 (a)(1)(i) and (ii) should be modified as follows (added language in red):

  • (i) a list of all ingredients in descending order of predominance by weight in the product, including but not limited to total Δ9-Tetrahydrocannabinol concentration, CBD and any other cannabinoids over 0.05%; and the cannabinoid in the highest concentration in the product
  • (ii) the number of servings per package or container, including the amount of measurable cannabinoids in milligrams per serving of the single cannabinoid that is in the highest concentration and the total major cannabinoid content of the package. If applicable, the amount of total Δ9-Tetrahydrocannabinol in milligrams per serving and milligrams per package shall be stated on the label;


  1. THC Warning on Labels Should Be Deleted (Section 1005.9(a)(f)(2))

This section should be deleted in its entirety, or at most acknowledge that the product is derived from hemp and may contain THC. Consumers will have access to the QR code so they can see how much THC is in a product.


  • (2) a warning stating that the product is derived from hemp and may contain THC which could result in the consumer failing a drug test for marijuana; 


  1. Font Size (Section 1005.9(a)(f))

Adding font size requirements to the already small label will cause most manufacturers to switch to larger packaging, creating unnecessary costs and waste of resources. Including the “clear and conspicuous” language provides a satisfactory standard. Below is a demonstration on how the arbitrary font requirement would affect a common 1 oz hemp oil bottle with standard 2” x 4” labeling.


  • (f) All cannabinoid hemp products offered for retail sale shall include the following warnings on the product label or packaging, in a manner that is clear and conspicuous, and be written in text no smaller than size 8-point font:


  1. Expiration Date (Section 1005.9(2)) 

To comply with general food and supplement CFR labeling requirements the NYCGPA recommends either changing from “expiration date” to a “best by” date, or allowing the manufacturer to choose.


  • (2) an expiration date, or best by date 
  1.  20% Margin for Testing and Labeling (Section 1005.8(a)(6)) 

This section should be revised to allow for more flexibility in testing results and labeling for concentration of cannabinoid content. From the experience of our members working with many accredited laboratories, the margin of error on testing combined with small batches of natural compounds staying within a 10% margin across manufacturing and testing is very difficult and ultimately for the consumer unnecessary. For your average retail product increasing to a 20% margin will only change the final serving by a few milligrams of the major cannabinoid. In addition, the FDA also permits certain naturally occurring nutrients to be present at 80% or more or 120% or less of the value declared in nutrition labeling. The NYCGPA therefore asks the DOH to take a similar approach to cannabinoid content label claims.


  • (6) accurately reflect testing results and not contain less than 90 80 percent or more than 110 120 percent of the concentration of total cannabinoid content as listed on the product label;
  1. Additional Required Statements (Section 1005.9(8))

The NYCGPA suggests deleting subsection (8) from Section 1005.9. Since packaging and labeling is such a large issue and mistakes in regulation can be detrimental to small businesses, giving the DOH unlimited power in creating label changes creates uncertainty and risk that does not serve consumers or businesses. Packaging requirements need to follow either FDA CFR standards or be done in consensus with stakeholders.


  • (8) any other marking, statement or symbol as required by the department. 


  1. Marketing (Section 1005.9(b))

The NYCGPA agrees that companies should not be targeting minors in packaging or marketing materials. However, this section is vague and should be revised to provide additional clarity as to what type of packaging the DOH would consider “attractive to anyone under 18 years of age.” The NYCGPA recommends adding details and examples as to what will not be allowed.


  • (b) No cannabinoid hemp product shall be packaged or contained in such a manner so as to be  attractive to anyone under 18 years of age including no cartoons or images popularly used to advertise to children, or the imitation of a candy label


The NYCGPA membership represents every link of the cannabinoid hemp supply chain. They realize that retailers are perhaps the most important piece to ensure a marketplace that offers economic opportunity for the hundreds of small-scale hemp farmers and processors across New York State. Retailers are also key to ensuring products sold in New York are produced to the quality standards necessary in protecting public health and ensuring a level playing field for our producers. However, current proposed regulations relating to the applications and requirements for retailers are overburdensome and onerous. We fear that without changes, the number of retailers will shrink – resulting in a significant loss of sales for New York hemp operators. We encourage the DOH to enact the proposed changes below in order to prioritize both public health and continued development of the cannabinoid hemp supply chain.

Application for Cannabinoid Hemp Retail License (Section 1005.3)

When a hemp cannabinoid retailer becomes licensed, they are committing to following the regulations set forth by the DOH including all labeling, quality, and packaging standards. It is unnecessary and impractical to require the applicant to include the manufacturer and descriptions of all cannabinoid hemp products they intend to sell. This requirement serves no public health or compliance purpose, especially when considering the first rule of Section 1005.3 specifically prohibits the sale of any products in violation of Article 33-B of the Public Health Law.


We urge the DOH to strike the following in Section 1005.3(b):

  • (3) the name of the manufacturer or cannabinoid hemp processor, and state or country of manufacture, for all cannabinoid hemp products the applicant intends to offer for sale;


  • (4) a summary and description of the types and forms of cannabinoid hemp products the applicant intends to offer for sale;


Retail Licensing Fees (Section 1005.3(5)(c))

As the marketplace continues to mature, the NYCGPA is concerned that prohibitively high license fees will deter retailers from becoming licensed, especially if they have not previously sold cannabinoid hemp products. For many retailers, hemp is only a small portion of their total sales and would represent one of the few products that require a license. In fact, tobacco license fees in New York State are $200.00, or 33% less than the cannabinoid hemp retail license fee. The $300.00 license fee for cannabinoid hemp retailers will drastically lower the amount of applicants statewide and result in lower total fee revenues for the State compared to a more manageable fee. Further, the current global pandemic has put a significant strain on all retail businesses across New York State and this new fee will hurt business owners who are facing lower sales.


We urge the department to adjust the fee to $100.00, which would be more manageable for small businesses, especially during these difficult economic times. Section 1005.3(5)(c) should be amended as follows:

  • (c) All applications under this section shall be accompanied by refundable license fee of $300 $100 for each retail facility to be licensed by the department.


Requirements for cannabinoid hemp retailers (Section 1005.11)

While we appreciate the need for enforcement of the strict quality, labeling, and packaging standards set forth in the proposed regulations, creating onerous requirements for recordkeeping would prove to be costly and unnecessary for retailers. We support the requirement to keep records relating to the source of products sold, however it is unnecessary to require the retention of such records indefinitely. We propose amending this provision to require record retention for 60 days, which would serve as an extension of 30 days past standard invoice terms and allow for a significant enough sample size to ensure compliance during a surprise inspection.


We ask the DOH to amend Section 1005.11(e) as follows (added language in red):

  • (e) Cannabinoid hemp retailers shall maintain sufficient records, for a period of 60 days from purchase, of where cannabinoid hemp products were purchased from, including the name of the cannabinoid hemp processor, and the wholesaler or permitted distributor if applicable. Where cannabinoid hemp products are purchased from an out of state manufacturer, the cannabinoid hemp retailer shall also maintain the name, address, certificate of analysis and evidence that cannabinoid hemp products meet all of the requirements of this Part.


Allowing for the Sale of Hemp Cannabinoid Products at Temporary Events


Expanding the consumer base for New York made cannabinoid hemp products is crucial to developing a hemp industry that is economically robust. Events such as farmer’s markets, craft shows, festivals, and the New York State Fair are places where consumers go to learn more about New York made products and purchase them. These temporary opportunities also offer a lower cost option for producers and brands to reach consumers while offering higher margins.

There is a rich history of temporary markets in New York including the Great New York State Fair and the hemp extract regulations should acknowledge this business opportunity by providing for a retail license that allows the licensee to travel and market their products. There is a similar permit for alcohol producers and we encourage the DOH to do the same for cannabinoid hemp retailers.



Transdermal patches have proven to be a safe and effective way to deliver small doses of cannabinoids and should be considered a topical, not an ingestible product. We would like to see patches be removed from the list of non-allowable products in Section 1005.8 (a)(5).

SUGGESTED AMENDMENTS ON TRANSDERMAL PATCHES (including previously suggested amendments to flower)

  • (5) not be in the form of an injectable, transdermal patch, inhaler, suppository, flower product including cigarette, cigar or pre-roll, or any other disallowed form as determined by the department;


We appreciate the need to adequately fund the administration of the cannabinoid hemp program, however the proposed regulations levy overly burdensome fees on processors and manufacturers. We recommend lowering the fees to be more in line with New York State Liquor Authority’s Winery License Fees.


  • (6)(f)(3) payment of licensure fee as follows:
    • (i) Cannabinoid Hemp Processor – Extraction and Manufacturing: $4,500 $2,500 per location; or
    • (ii) Cannabinoid Hemp Processor – Manufacturing Only: $2,000 $1,000 per location;


In closing, the NYCGPA appreciates the opportunity to comment on the Proposed Regulations. As a New York State Association, our membership respectfully urges the DOH to include the suggested modifications described above. By encouraging compliance and protecting consumers the New York hemp industry will lead the nation in producing safe and high-quality products. The Hemp Extract Law creates a mechanism for feedback from industry representatives. Section 545 states:

The commissioner shall appoint a New York state industrial hemp and hemp extract workgroup, composed of researchers, producers, processors, manufacturers and trade associations, to make recommendations for the industrial hemp and hemp extract programs, state and federal policies and policy initiatives, and opportunities for the     promotion and marketing of industrial hemp and hemp extract as consistent with federal and state laws, rules and regulations, which workgroup shall continue for such time as the commissioner deems appropriate.

The Governor and Legislature in their wisdom saw an opportunity in this new industry to create direct input that will only enhance the regulations and develop the industry. The NYCGPA urges the DOH to create the Working Group to continue the dialogue and continue creating a world-class hemp industry for New York State.




¹§ 506. Growth,  sale,  distribution,  transportation and processing of hemp and products derived from such hemp permitted.  1.  Notwithstanding any  provision  of  law  to the contrary, hemp and products derived from such hemp are agricultural products  which  may  be  grown,  cultivated, produced,  processed,  manufactured,  possessed  in the state, and sold, distributed, or transported in  the  state,  pursuant  to  authorization under   federal   law, the   provisions   of   this  article,  article thirty-three-B of the public health law or any other state law.