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GRAS for Grass: Is Generally Recognized as Safe a Viable Pathway for CBD Market Access?
[vc_row][vc_column][vc_column_text]If you have been following recent cannabidiol (CBD) discussions happening around the world, you'll know that the evolving regulatory landscape is leaving many brands confused about their market access options. As regulatory consultants, we field questions daily about CBD compliance and marketing, both from food and supplement brands and CBD suppliers looking to get to market quickly. To help you find an efficient pathway to market, we've put together a list of frequently asked questions about CBD marketing, sales, and compliance—including GRAS—for the U.S. market. Read on for answers, then get in touch with us to discuss options specific to your company's needs and objectives.
Q: I SEE BRANDS SELLING CANNABIDIOL (CBD) PRODUCTS EVERYWHERE. HOW ARE THEY ABLE TO DO THIS?
There's no question that CBD products are showing up all over the place, especially in foods, beverages, and dietary supplements. This is despite the FDA's clear stance that CBD cannot be legally added to foods or dietary supplements. Statements made recently from the FDA suggest that they may consider a regulatory pathway to allow CBD in food or dietary ingredients but the details are currently unclear.
However, what is clear is that safety and proof thereof will be required. It should be pointed out that this does not include hemp seed products where the CBD has not been isolated. This is because they have a history in the food supply. Moreover, recently Generally Recognized As Safe (GRAS) conclusions notified to FDA for hemp seed oil, hemp seed protein, and dehulled hemp seed received no questions letters from FDA .
So how are companies selling foods and supplements with extracted CBD in them? The short answer is that a major grey area exists regarding specific legislation and enforcement. Furthermore, cannabis is regulated differently at the federal and at the state levels, allowing state legislation to sometimes contradict federal—especially in terms of transport across state lines. While some states do permit the legal sale of cannabis-derived products with a THC content >0.3%, these remain illegal at a federal level.
This has created a paradox where some companies, typically smaller brands, are choosing to ignore FDA's regulations in the hopes of flying under the radar and selling their dietary supplements and foods in the interim.
This is certainly not advisable from a regulatory or risk standpoint, nor is it a long-term success strategy for brands.
In Spring 2019, the FDA will open discussion for public input in efforts to define legal market pathways for CBD. Our regulatory team will be closely monitoring these discussions so we can advise our clients immediately.
Q: WITH THE PASSAGE OF THE FARM BILL, WHAT OPTIONS DOES MY COMPANY HAVE TO INCLUDE CBD AS AN INGREDIENT IN FOODS AND SUPPLEMENTS?
The 2018 Farm Bill removes industrial hemp from the list of Schedule I Controlled Substances. This may open up possible pathways in the future, but it is definitely not an automatic green light for CBD.
It should be noted that it will take time for regulations and licensing to reflect the changes put forth from the 2018 Farm Bill. In fact, the USDA indicated that regulations will not be in place until 2020.
The Farm Bill does state that to meet the definition of “hemp,” and to therefore be federally legal, a product would have contain less than 0.3% THC dry weight, in the extract as well as the finished product. Therefore, companies must have a rigorous testing protocol implemented to ensure compliance.
Q: WHAT IS GRAS AND IS IT AN OPTION FOR MARKETING CBD?
Yes, GRAS is something to consider for CBD and is one of the pathways a company can take to establish two things: the safety of their product's intended use, and the longevity of their product.
GRAS is a possible regulatory compliance pathway for new food ingredients to be added into the U.S. food supply.
Validating the safety of CBD is a necessary step regardless of the regulatory pathway travelled (GRAS, New Dietary Ingredient Notification [NDIN], Food Additive Petition, or Investigational New Drug [IND]), and much of the basic pre-clinical data to adequately support the safety of a new ingredient is the same.
Q: WHAT CLAIMS, IF ANY, CAN I MAKE FOR CBD PRODUCTS?
GRAS is a means of supporting safety, not efficacy, so it does not help with claims substantiation—a major area of risk for companies making any claims on the label or in marketing (including websites and social media).
It's worth noting that FDA has issued warning letters for unsubstantiated claims for CBD products, though to date these have been for aggressive disease claims. So, whatever you do, DO NOT make disease claims.
Above all, it is the company's responsibility to make sure their CBD claims are substantiated by high-quality scientific evidence. Typically this involves clinical trials.
Q: WHAT'S THE PROCESS FOR SECURING GRAS STATUS FOR CBD?
Since GRAS is based on ingredient-specific safety evidence, we recommend conducting adequate safety testing on your product before beginning the GRAS process. This can decrease wait times and improve the likelihood of accepted GRAS status. Then, a self-affirmed GRAS can be initiated which many companies are doing as we speak.
A New Dietary Ingredient Notification (NDIN) is a similar, but distinct, route applicable to dietary ingredients. To date, FDA maintains that CBD does not qualify as a dietary ingredient. To learn more, see GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?
Q: HOW LONG DOES IT TAKE FROM SUBMISSION TO REACH A GRAS CONCLUSION?
When safety literature supporting your ingredient is available in the public domain, it can take less than a year to secure GRAS status. If a full suite of safety evidence is initiated, it can take one-and-a-half to two years to reach a GRAS conclusion.
Q: I WANT TO LEGALLY SELL A FOOD OR DIETARY SUPPLEMENT CONTAINING CBD. WHAT ARE MY OPTIONS?
The first step is validating safety. As mentioned, GRAS is a possible pathway to do this (and many brands are currently in the process). Companies can also generate evidence, such as through clinical trials, to further support product safety and to substantiate their claims (a useful marketing tool for brands looking to differentiate).
Companies should also remember that while the 2018 Farm Bill includes a provision allowing for transportation of hemp and hemp products across state lines, it includes the provision that the hemp/hemp product must be produced in accordance with the subtitle G of the Agricultural Marketing Act of 1946. Currently there are no federally approved state programs for hemp production and therefore, individual state laws still currently govern the sale and transport of these products. FDA has not yet elucidated a clear pathway for compliance on a federal level and will most likely not overstep state legislation when they do, meaning that States may still have more restrictive regulations.
Q: WHAT SHOULD RAW MATERIAL SUPPLIERS KNOW ABOUT CBD?
Raw material suppliers looking to sell CBD in the U.S. need to have documentation in place to prove their finished product is safe and qualify their raw material (and the original supplier, if applicable) which includes proof that it is compliant with the regulations.
Q: WHAT SHOULD FINISHED BRANDS KNOW ABOUT CBD?
It is very important that companies selling finished product to the consumer know that it is their responsibility to source raw CBD materials that are compliant with the regulations. Part of that is to look for CBD products with GRAS status which assures safety. They should also qualify their supplier and ask to see documentation showing the CBD is compliant and tested for quality control and contaminants. In addition, they should not make disease claims or use the words “treat” or “cure.” It is also is advised that you seek legal counsel for a final review of claims and substantiation.
If you need assistance with CBD compliance, claims, research, or testing, contact the team at Nutrasource for more information.[/vc_column_text][vc_separator][vc_column_text]Note: The views and opinions expressed here are those of the author(s) and contributor(s) and do not necessarily reflect those of the publisher and editors of WholeFoods Magazine.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Amy Mozingo, MS, is Director of Operations at GRAS Associates (a Nutrasource subsidiary). She has over 15 years of experience in industry and consulting, holds a certificate as a Preventive Control Qualified Individual (PCQI), and is trained and experienced in ingredient approvals (GRAS, NDIN, FAP, CAP), product labelling, formulation reviews, and current good manufacturing requirements for dietary supplements. Amy is also an Associate with RNI Consulting and serves as international regulatory liaison for Nutrasource and GRAS Associates. Connect with Amy on LinkedIn.
Dr. Susan J. Hewlings, Ph.D., RD, is Director of Scientific Affairs at Nutrasource. With over 20 years in nutrition, sports nutrition, and scientific consulting for the dietary supplement and medical industries, Dr. Hewlings helps clients support their global market launch strategies by substantiating claims with scientific evidence. Connect with Dr. Hewlings on LinkedIn.[/vc_column_text][/vc_column][/vc_row]
Q: I SEE BRANDS SELLING CANNABIDIOL (CBD) PRODUCTS EVERYWHERE. HOW ARE THEY ABLE TO DO THIS?
There's no question that CBD products are showing up all over the place, especially in foods, beverages, and dietary supplements. This is despite the FDA's clear stance that CBD cannot be legally added to foods or dietary supplements. Statements made recently from the FDA suggest that they may consider a regulatory pathway to allow CBD in food or dietary ingredients but the details are currently unclear.
However, what is clear is that safety and proof thereof will be required. It should be pointed out that this does not include hemp seed products where the CBD has not been isolated. This is because they have a history in the food supply. Moreover, recently Generally Recognized As Safe (GRAS) conclusions notified to FDA for hemp seed oil, hemp seed protein, and dehulled hemp seed received no questions letters from FDA .
So how are companies selling foods and supplements with extracted CBD in them? The short answer is that a major grey area exists regarding specific legislation and enforcement. Furthermore, cannabis is regulated differently at the federal and at the state levels, allowing state legislation to sometimes contradict federal—especially in terms of transport across state lines. While some states do permit the legal sale of cannabis-derived products with a THC content >0.3%, these remain illegal at a federal level.
This has created a paradox where some companies, typically smaller brands, are choosing to ignore FDA's regulations in the hopes of flying under the radar and selling their dietary supplements and foods in the interim.
This is certainly not advisable from a regulatory or risk standpoint, nor is it a long-term success strategy for brands.
In Spring 2019, the FDA will open discussion for public input in efforts to define legal market pathways for CBD. Our regulatory team will be closely monitoring these discussions so we can advise our clients immediately.
Q: WITH THE PASSAGE OF THE FARM BILL, WHAT OPTIONS DOES MY COMPANY HAVE TO INCLUDE CBD AS AN INGREDIENT IN FOODS AND SUPPLEMENTS?
The 2018 Farm Bill removes industrial hemp from the list of Schedule I Controlled Substances. This may open up possible pathways in the future, but it is definitely not an automatic green light for CBD.
It should be noted that it will take time for regulations and licensing to reflect the changes put forth from the 2018 Farm Bill. In fact, the USDA indicated that regulations will not be in place until 2020.
The Farm Bill does state that to meet the definition of “hemp,” and to therefore be federally legal, a product would have contain less than 0.3% THC dry weight, in the extract as well as the finished product. Therefore, companies must have a rigorous testing protocol implemented to ensure compliance.
Q: WHAT IS GRAS AND IS IT AN OPTION FOR MARKETING CBD?
Yes, GRAS is something to consider for CBD and is one of the pathways a company can take to establish two things: the safety of their product's intended use, and the longevity of their product.
GRAS is a possible regulatory compliance pathway for new food ingredients to be added into the U.S. food supply.
Validating the safety of CBD is a necessary step regardless of the regulatory pathway travelled (GRAS, New Dietary Ingredient Notification [NDIN], Food Additive Petition, or Investigational New Drug [IND]), and much of the basic pre-clinical data to adequately support the safety of a new ingredient is the same.
Q: WHAT CLAIMS, IF ANY, CAN I MAKE FOR CBD PRODUCTS?
GRAS is a means of supporting safety, not efficacy, so it does not help with claims substantiation—a major area of risk for companies making any claims on the label or in marketing (including websites and social media).
It's worth noting that FDA has issued warning letters for unsubstantiated claims for CBD products, though to date these have been for aggressive disease claims. So, whatever you do, DO NOT make disease claims.
Above all, it is the company's responsibility to make sure their CBD claims are substantiated by high-quality scientific evidence. Typically this involves clinical trials.
Q: WHAT'S THE PROCESS FOR SECURING GRAS STATUS FOR CBD?
Since GRAS is based on ingredient-specific safety evidence, we recommend conducting adequate safety testing on your product before beginning the GRAS process. This can decrease wait times and improve the likelihood of accepted GRAS status. Then, a self-affirmed GRAS can be initiated which many companies are doing as we speak.
A New Dietary Ingredient Notification (NDIN) is a similar, but distinct, route applicable to dietary ingredients. To date, FDA maintains that CBD does not qualify as a dietary ingredient. To learn more, see GRAS or NDIN: Which is the Right Regulatory Strategy for My Ingredient?
Q: HOW LONG DOES IT TAKE FROM SUBMISSION TO REACH A GRAS CONCLUSION?
When safety literature supporting your ingredient is available in the public domain, it can take less than a year to secure GRAS status. If a full suite of safety evidence is initiated, it can take one-and-a-half to two years to reach a GRAS conclusion.
Q: I WANT TO LEGALLY SELL A FOOD OR DIETARY SUPPLEMENT CONTAINING CBD. WHAT ARE MY OPTIONS?
The first step is validating safety. As mentioned, GRAS is a possible pathway to do this (and many brands are currently in the process). Companies can also generate evidence, such as through clinical trials, to further support product safety and to substantiate their claims (a useful marketing tool for brands looking to differentiate).
Companies should also remember that while the 2018 Farm Bill includes a provision allowing for transportation of hemp and hemp products across state lines, it includes the provision that the hemp/hemp product must be produced in accordance with the subtitle G of the Agricultural Marketing Act of 1946. Currently there are no federally approved state programs for hemp production and therefore, individual state laws still currently govern the sale and transport of these products. FDA has not yet elucidated a clear pathway for compliance on a federal level and will most likely not overstep state legislation when they do, meaning that States may still have more restrictive regulations.
Q: WHAT SHOULD RAW MATERIAL SUPPLIERS KNOW ABOUT CBD?
Raw material suppliers looking to sell CBD in the U.S. need to have documentation in place to prove their finished product is safe and qualify their raw material (and the original supplier, if applicable) which includes proof that it is compliant with the regulations.
Q: WHAT SHOULD FINISHED BRANDS KNOW ABOUT CBD?
It is very important that companies selling finished product to the consumer know that it is their responsibility to source raw CBD materials that are compliant with the regulations. Part of that is to look for CBD products with GRAS status which assures safety. They should also qualify their supplier and ask to see documentation showing the CBD is compliant and tested for quality control and contaminants. In addition, they should not make disease claims or use the words “treat” or “cure.” It is also is advised that you seek legal counsel for a final review of claims and substantiation.
If you need assistance with CBD compliance, claims, research, or testing, contact the team at Nutrasource for more information.[/vc_column_text][vc_separator][vc_column_text]Note: The views and opinions expressed here are those of the author(s) and contributor(s) and do not necessarily reflect those of the publisher and editors of WholeFoods Magazine.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_separator][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]Amy Mozingo, MS, is Director of Operations at GRAS Associates (a Nutrasource subsidiary). She has over 15 years of experience in industry and consulting, holds a certificate as a Preventive Control Qualified Individual (PCQI), and is trained and experienced in ingredient approvals (GRAS, NDIN, FAP, CAP), product labelling, formulation reviews, and current good manufacturing requirements for dietary supplements. Amy is also an Associate with RNI Consulting and serves as international regulatory liaison for Nutrasource and GRAS Associates. Connect with Amy on LinkedIn.
Dr. Susan J. Hewlings, Ph.D., RD, is Director of Scientific Affairs at Nutrasource. With over 20 years in nutrition, sports nutrition, and scientific consulting for the dietary supplement and medical industries, Dr. Hewlings helps clients support their global market launch strategies by substantiating claims with scientific evidence. Connect with Dr. Hewlings on LinkedIn.[/vc_column_text][/vc_column][/vc_row]
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