Treatment with CBD

CBD product misbranding

A number of prior investigations found that CBD product misbranding a wide spread problem. The amount of CBD products claim on the label might be far from what they actually contain. We discuss the following:

Investigations to assess the true CBD content of products

Several groups (e.g. Leafly, WTHR) have conducted investigations to assess the cannabidiol (CBD) content of various products. They found that the majority of the products they tested failed by having either too little or too much CBD compared to what they claimed on the label.

For example, Leafly found 23 out of 47 CBD products (49%) misbranded (7 overperforming and 16 underperforming, with 5 containing no CBD whatsoever). Moreover, WTHR found 10 out of 20 (50%) misbranded CBD products (all underperforming, with 3 containing no CBD whatsoever). While these investigations are by far not representative of the entire CBD market, many believe that it is not an exaggeration to say that about half of CBD products currently available on the market are indeed mislabeled.

However, very few of these reports discuss the regulatory background of the labeling of CBD products, even though it is essential knowledge for compliance purposes. In this article, we are giving you a summary of the relevant FDA and FD&C Act documents.

FDA: Class I, Class II, and Third Group nutrients

The FDA differentiates between Class I and Class II nutrients.

Class I nutrients are those added in fortified or fabricated foods. They include vitamins, minerals, protein, dietary fiber, or potassium. As such, Class I nutrients must be present at 100% or more of the value declared on the label.

Class II nutrients are those that occur naturally in a food product. They include vitamins, minerals, protein, total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated and monounsaturated fat, or potassium. As such, Class II nutrients must be present at 80% or more of the value declared on the label.

The Third Group nutrients include calories, sugars, total fat, saturated fat, cholesterol, and sodium.

Based on this description, CBD appears to belong to the Class II nutrients. The above investigations also assessed the CBD content of the selected products as Class II.

Watch this 35:53 minute video by U.S. Food and Drug Administration: “FDA’s Role in Improving Nutrition: Labeling and Other Authorities”

Code of Federal Regulations: misbranding

Having established that, the Code of Federal Regulations stipulates that under section 403(a) of the Federal Food, Drug, and Cosmetic Act, the nutrient content of Class II foods must be at least equal to 80% of the value for that nutrient declared on the label. However, no regulatory action will be taken if the nutrient value is below this level by less than statistical significance. Given that statistical significance is generally accepted to be p<0.05, this apparently means: 80% – 0.05% of 80% = 76% (that’s -24%).

Furthermore, it is deemed mislabeled if the nutrient content is greater than 120% of the value on the label. Similar to the lower limit, no regulatory action will be taken if the nutrient value falls above this level by less than statistical significance. Given a statistical significance of p<0.05, this apparently means: 120% + 0.05% of 120% = 126% (that’s +26%).

The Code of Federal Regulations further notes that: “failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this paragraph (g)(11), would result in the food being misbranded under section 403(a)(1) of the act”. This means that even if a product’s nutrient content meets the labeling expectations of section 403(a), the product will be misbranded if the producer does not have appropriate record making and keeping practices.

FDA warning letters about CBD misbranding

The FDA has issued several warning letters because of compliance problems regarding CBD: altogether 18 in 2015, 22 in 2016, 4 in 2017, 1 in 2018, and 22 in 2019. In addition, in November of 2019 the FDA published a statement about cannabis and cannabis-derived compounds including CBD, which caused a huge uproar.

The FDA has received much criticism about approving dangerous drugs and approving them without proper clinical trials. Still, we have to accept that as of right now, the FDA is the only “watchdog” in the United States that has the mandate to protect consumers from bad foods and drugs.

This actually has worked in the past – and example is Contergan, a drug that wreaked havoc among pregnant women in Europe but not in the US because the FDA refused to approve it (thanks to Dr. Kelsey).

As a matter of fact, the FDA approves medications based on an array of preclinical and clinical trials that were published in peer-reviewed biomedical journals. This process is the basis of compliance and is supposed to ensure that consumers and patients receive medications that are effective and have few or manageable side effects.

Summary

We have to agree that there have to be ways to protect consumers. Federal laws and regulations exist with the aim to provide this protection (and they may achieve this to various degrees – but this is the topic of another discussion). Regardless, given that the federal agencies are the ones that set the rules, what CBD companies can do is to know the rules and play by them in order to avoid being fined, shut down, or prosecuted.

As such, the first step in the compliance process is to ensure that CBD products are labeled correctly.

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