Todd Harrison, Venable06.01.16
In May the U.S. Food and Drug Administration (FDA) finalized its Compliance Policy Guide Sec. 690.150 “Labeling and Marketing of Dog and Cat Food Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent Diseases” (CPG). FDA had initially issued a draft of this compliance policy guide in September of 2012.
The final CPG, like the draft form, makes clear that marketing animal foods with disease claims is technically not permitted and renders the product an adulterated unapproved new drug, while setting forth circumstances that if met will make it less likely for the agency to seek an enforcement action against a company marketing a product with disease claims. Like the draft CPG, the final version also places a great deal of emphasis on the importance of these types of cat and dog foods being marketing only through and under the supervision of veterinarians.
Criteria for Enforcement Discretion
The criteria for enforcement discretion included in the final CPG are generally similar to those included in the draft CPG with the exception of two additional criteria: 1) that the product cannot present a known safety risk when used as labeled; and 2) the product must be manufactured in accordance with cGMPs applicable to animal foods.
Other key criteria include: 1) distribution of labeling and other communications, and electronic communications bearing disease claims solely to veterinary professionals; 2) general requirement that none of the claims be false or misleading; and 3) a prohibition on the inclusion of any disease claim on the label of the product.
Key Difference for Pet Supplement Companies
While the final CPG is similar to the draft, there are a few key differences. Most importantly for pet supplement manufacturers, the final CPG specifically states that the guidance “does not apply to products intended for nutritional supplementation of foods for animals and/or products marketed as dietary supplements for animals.” This CPG now only applies to products that are “labeled and/or marketed to provide all or most of the nutrients in support of meeting the animal’s total daily nutrient requirements by serving as the pet’s sole diet.
The draft guidance only required that the product be “marketed to provide nutrients in support of meeting the animal’s total daily nutrient requirements.” The draft language left open the possibility that the CPG applied to some animal supplements, however, the final language clearly cuts off that possibility.
CBD Update
The cannabidiol (CBD) industry continues to grow at a remarkable pace. Companies marketing CBD products are incredibly diverse and include not only human dietary supplement companies but also pet supplement, vapor and homeopathic drug industries. These companies believe that all of their products are being lawfully marketed and ignore FDA’s warnings to the contrary.
Indeed, many of the companies simply state that recent warning letters are all about claims and have nothing to do with the ingredient itself. It is true that the first batch of FDA warning letters concentrated on claims, however, the most recent warning letters clearly stated that CBD is not a permissible dietary ingredient. Yet, the same refrain continues about claims.
FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.
Those marketing CBD take the view that as a constituent of hemp, CBD has been present in the food supply prior to the institution of clinical trials. However, this ignores the plain language of the statute, which states that a new dietary ingredient is exempt from the notification provisions of the Act if it was present in the food supply as an “article” used as food (see FD&C Act § 413).
It is hemp that is the article of food, not CBD. Indeed, the levels of CBD in hemp are at trace levels similar to the level of mevinolin (the natural form of Lovastatin) in red yeast rice before creating a production process that significantly increased its level in red yeast rice. In that instance, FDA took regulatory action against Pharmanex, stating that the red yeast rice supplement whose manufacturing process has been manipulated to significantly increase its mevinolin content was precluded from being marketed due to the agency’s approval of Lovastatin as a drug. The 10th Circuit Court of appeals ultimately agreed with FDA on its interpretation. Thus, companies marketing CBD continue to take significant risk with their legal position.
Regardless, at a minimum, CBD is a new dietary ingredient subject to notification. Again, the red yeast rice scenario is instructive. In that case, FDA argued successfully that the article is not red yeast rice but the mevinolin, and mevinolin has simply never been used as an article of food. Similarly, CBD has not been used as an article of food and, thus, is subject to the notification to FDA as a new dietary ingredient; and failure to do so causes the ingredient to be adulterated as a matter of law.
My opinion is that CBD may be marketed as a dietary ingredient if two conditions are met: 1) it was marketed prior to the filing of the IND and the institution of substantial clinical trials, and 2) a notification is filed. If the CBD industry believes the ingredient is lawfully marketed, it should follow the process and see if FDA refuses to file a notification, and then take the agency to court over the issue. I would only follow this strategy if condition 1) can be satisfied as the Pharmanex red yeast rice case is a major impediment to the argument that hemp is the article of food. Of course, the 10th Circuit is only one appeals court and its jurisdiction is limited, so it’s possible another Circuit Court would have come to a different conclusion.
Regardless, I believe the case will be litigated at some point, but until that time companies that invest heavily into CBD assets are at risk until the courts resolve the legal status of CBD.
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
The final CPG, like the draft form, makes clear that marketing animal foods with disease claims is technically not permitted and renders the product an adulterated unapproved new drug, while setting forth circumstances that if met will make it less likely for the agency to seek an enforcement action against a company marketing a product with disease claims. Like the draft CPG, the final version also places a great deal of emphasis on the importance of these types of cat and dog foods being marketing only through and under the supervision of veterinarians.
Criteria for Enforcement Discretion
The criteria for enforcement discretion included in the final CPG are generally similar to those included in the draft CPG with the exception of two additional criteria: 1) that the product cannot present a known safety risk when used as labeled; and 2) the product must be manufactured in accordance with cGMPs applicable to animal foods.
Other key criteria include: 1) distribution of labeling and other communications, and electronic communications bearing disease claims solely to veterinary professionals; 2) general requirement that none of the claims be false or misleading; and 3) a prohibition on the inclusion of any disease claim on the label of the product.
Key Difference for Pet Supplement Companies
While the final CPG is similar to the draft, there are a few key differences. Most importantly for pet supplement manufacturers, the final CPG specifically states that the guidance “does not apply to products intended for nutritional supplementation of foods for animals and/or products marketed as dietary supplements for animals.” This CPG now only applies to products that are “labeled and/or marketed to provide all or most of the nutrients in support of meeting the animal’s total daily nutrient requirements by serving as the pet’s sole diet.
The draft guidance only required that the product be “marketed to provide nutrients in support of meeting the animal’s total daily nutrient requirements.” The draft language left open the possibility that the CPG applied to some animal supplements, however, the final language clearly cuts off that possibility.
CBD Update
The cannabidiol (CBD) industry continues to grow at a remarkable pace. Companies marketing CBD products are incredibly diverse and include not only human dietary supplement companies but also pet supplement, vapor and homeopathic drug industries. These companies believe that all of their products are being lawfully marketed and ignore FDA’s warnings to the contrary.
Indeed, many of the companies simply state that recent warning letters are all about claims and have nothing to do with the ingredient itself. It is true that the first batch of FDA warning letters concentrated on claims, however, the most recent warning letters clearly stated that CBD is not a permissible dietary ingredient. Yet, the same refrain continues about claims.
FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.
Those marketing CBD take the view that as a constituent of hemp, CBD has been present in the food supply prior to the institution of clinical trials. However, this ignores the plain language of the statute, which states that a new dietary ingredient is exempt from the notification provisions of the Act if it was present in the food supply as an “article” used as food (see FD&C Act § 413).
It is hemp that is the article of food, not CBD. Indeed, the levels of CBD in hemp are at trace levels similar to the level of mevinolin (the natural form of Lovastatin) in red yeast rice before creating a production process that significantly increased its level in red yeast rice. In that instance, FDA took regulatory action against Pharmanex, stating that the red yeast rice supplement whose manufacturing process has been manipulated to significantly increase its mevinolin content was precluded from being marketed due to the agency’s approval of Lovastatin as a drug. The 10th Circuit Court of appeals ultimately agreed with FDA on its interpretation. Thus, companies marketing CBD continue to take significant risk with their legal position.
Regardless, at a minimum, CBD is a new dietary ingredient subject to notification. Again, the red yeast rice scenario is instructive. In that case, FDA argued successfully that the article is not red yeast rice but the mevinolin, and mevinolin has simply never been used as an article of food. Similarly, CBD has not been used as an article of food and, thus, is subject to the notification to FDA as a new dietary ingredient; and failure to do so causes the ingredient to be adulterated as a matter of law.
My opinion is that CBD may be marketed as a dietary ingredient if two conditions are met: 1) it was marketed prior to the filing of the IND and the institution of substantial clinical trials, and 2) a notification is filed. If the CBD industry believes the ingredient is lawfully marketed, it should follow the process and see if FDA refuses to file a notification, and then take the agency to court over the issue. I would only follow this strategy if condition 1) can be satisfied as the Pharmanex red yeast rice case is a major impediment to the argument that hemp is the article of food. Of course, the 10th Circuit is only one appeals court and its jurisdiction is limited, so it’s possible another Circuit Court would have come to a different conclusion.
Regardless, I believe the case will be litigated at some point, but until that time companies that invest heavily into CBD assets are at risk until the courts resolve the legal status of CBD.
Todd Harrison
Venable
Todd Harrison is partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com.
