For the majority of folks in the hemp CBD industry, the rules and regulations of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are new.
Not only are they new, but they are also practically another language.
In the process of learning the lingo and the ropes of these two agencies, we have learned some things. We think they will be interesting to anyone wanting to advance the hemp CBD industry—consumers and companies alike.
What Do the FDA and FTC Do?
Most people have heard of the FDA and FTC. Many people understand that they regulate and enforce policy relative to products sold in the United States. But we may not know the roles that they each play.
The Federal Trade Commission is a bipartisan federal agency with a dual mission to protect consumers and promote competition. The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. The FTC collects complaints about hundreds of issues from data security and deceptive advertising.
The Food and Drug Administration is responsible for protecting public health. They are responsible for the labeling of products.
The FTC and the FDA work together closely and share their databases—the FDA regulating labeling and the FTC regulating advertising of products.
It Starts With the FDA
When it comes to hemp CBD and other products, the truth is, enforcement really starts with the FDA.
The two primary responsibilities of the FDA include:
A. Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
B. Ensuring the safety of our nation’s food supply, supplements, and cosmetics.
A Closer Look at Group A — Drugs, Biological Products, and Medical Devices
A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. It is also a substance (other than food) intended to affect the structure or any function of the body.
A drug can also be a substance intended for use as a component of medicine.
Examples of drugs are: prescription drugs like morphine (for pain relief) and nonprescription drugs like Tylenol.
A biological product is used to diagnose, prevent, treat, and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules.
Examples of biological products are: vaccines and adalimumab (which treats arthritis). A medical device is an instrument, machine, implant, or other similar things, including a component part, or accessory.
A medical device is recognized and intended for use in the diagnosis of a disease or other conditions. They can also be intended for use in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
Examples of medical devices are: syringes and MRI machines.
Big Takeaway: The FDA defines Drugs, Biological Products and Medical Devices as items intended to diagnose, cure, mitigate or treat disease.
A Closer Look at Group B — Food, Supplements, and Cosmetics
These are a little easier to understand.
Food would be something you eat, like a jelly bean or slice of bread.
A dietary supplement is a vitamin; mineral; herb or other botanical; amino acid; or dietary substance. They are used to supplement your diet by increasing the total dietary intake of each of these substances. Hence the term “supplement”.
Examples of dietary supplements are: vitamin C and magnesium.
A cosmetic is a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. The key to cosmetics is that it is used topically, not internally.
Examples of cosmetics are: body cream and lipstick.
Big Takeaway: Food and Dietary Substances are taken internally. Cosmetics are used topically. The FDA defines them as items NOT intended to diagnose, cure, mitigate or treat disease.
Advancing Public Health
As part of all of this, the FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable. The FDA also helps the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
How Does the FDA Regulate?
How the FDA regulates a particular item depends on what type of item generally with the two groups A and B mentioned above.
The Double Life of a Jelly Bean
One of the most interesting things about the way the FDA regulates is that it all depends on how something is labeled and marketed. In other words, anything, even a jelly bean, can lead a double (or even triple!) life.
In August of this year, Lowell Schiller, from the FDA’s Office of Policy explained it this way:
“Let’s say I sell you a jelly bean and claim it will cure your cancer or relieve your pain. That jelly bean is a drug, and it’s subject to FDA’s drug authorities. But if the jelly bean is intended just as a tasty snack, and it’s not marketed with any drug claims, and there’s no other evidence that it’s intended for a drug use, then it’s not a drug.”
Big Takeaway: Words matter. It’s not the substance, but the words being used to describe the substance that matter. These words determine how the FDA categorizes a substance and therefore how they regulate that substance.
FDA Regulation of Cosmetics and Topicals
The law does not require cosmetic products and ingredients, except for color additives, to be approved by the FDA before they go on the market. However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly labeled.
How the FDA Approves Drugs
Drugs, whether they are prescription or over-the-counter, are regulated and approved by the Center for Drug Evaluation and Research (CDER). The CDER is the largest of the FDA’s six centers and is located in Silver Springs MD.
Prescription drugs must receive approval before they can be sold to the public.
Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market. It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the sponsor’s NDA containing the data and proposed labeling.
New over-the-counter (OTC) drugs can be brought to market under a similar process.
Where the Rubber Meets the Road: Health Claims
So what does it all mean? All these different ways the FDA views products? Well, probably the biggest thing that it means is what you can say about your product—the “claims” you can make about your product.
There are three types of health claims
Drug Claims are those claims which state that the product alters the physiology or function of any part of the human body. Cosmetic claims do not describe any physiological effect on the body.
A company can make a drug claim only after the FDA approves the claim. The FDA has the authority to force a company to remove its product from the store shelves if any drug claim is made about the product without prior agency approval. Or, when consumer safety is at risk, the FDA itself can seize the product.
Authorized Health Claims have been reviewed by the FDA and are allowed on food products or dietary supplements to show that a food or food component may reduce the risk of a disease or a health-related condition.
To be approved by the FDA as an authorized health claim, there must be significant scientific agreement (SSA) among qualified experts that the claim is supported. The standard for an authorized health claim is very high. There have only been 12 FDA Authorized Health Claims since 1990.
Qualified Health Claims (QHCs) are supported by scientific evidence but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. To ensure that these claims are not misleading, they must be accompanied by a disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.
Though the standard of scientific evidence for a Qualified Health Claim is not as high as for an Authorized Health Claim, it is high nonetheless. To use a QHC, one must obtain a letter from the FDA. There are only 35 such letters that have been issued and made available on the FDA’s website.
What Makes a Qualified Health Claim?
Here is an example of the Qualified Health Claims that were approved by the FDA for calcium and hypertension, pregnancy-induced hypertension, and preeclampsia.
1. Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.
2. Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during pregnancy. However, three other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension.
3. Three studies, including a large clinical trial, do not show that calcium supplements reduce the risk of preeclampsia during pregnancy. However, two other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of preeclampsia.
Structure/Function claims are different than Health Claims. These claims describe the relationship between a nutrient deficiency and disease, the effect of a nutrient or dietary ingredient on a structure of function in humans, or how the dietary ingredient maintains structure or function. They are focused on the maintenance of healthy metabolic function, not preventing disease.
The manufacturer is responsible for ensuring the accuracy and truthfulness of the claims, and they are not evaluated/approved by the FDA.
Structure/Function Claims appear on the labels of conventional foods, dietary supplements as well as drugs. Examples of this type of claim are: “calcium builds strong bones,” “fiber maintains bowel regularity,” and “antioxidants maintain cell integrity.”
Structure/Function claims on dietary supplements are not pre-approved by the FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading.
If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.
Structure/function claims for conventional foods focus on effects from the nutritional value. (Structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects.) The FDA does not require conventional food manufacturers to notify FDA about their structure/function claims, and disclaimers are not required for claims on conventional foods.
Nutrient Content Claims describe the level of a nutrient or food substance in a product, using terms like “good source,” “high in,” or “free.” Nutrient content claims are typically made for substances that have an established daily value, such as vitamins and minerals.
Financial Incentive for Comprehensive Studies of CBD Hemp?
The global pharmaceutical market is almost 1 trillion dollars with the US holding 45% of that market. The profit incentives for drug research to cure disease is high. $60 billion spent per year for industry research on drugs, biotechnology, and medical devices.
As a comparison, the fruit and vegetable industry in the US is about 100 billion dollars—20% of the US pharmaceutical industry. Total federal spending for nutrition research across all agencies is only about $1.5 billion per year.
In spite of these numbers, the truth is, our dietary habits are the leading driver of death and disability. Poor diet causes 700,000 deaths each year. Diseases like heart disease, stroke, obesity, Type 2 diabetes, cancers, immune function, brain health—all are influenced by what we eat.
We can see that research money for nutrition pales compared to the money that is poured into drugs, biotechnology, and medical devices. Will the research for CBD hemp be put at a lower echelon in the same way? That is the question.
While the amount of research done on CBD and other cannabinoids has certainly increased since the passage of the 2018 Farm Bill, the amount of research will most likely be at the same level as food and nutritional supplements.
The Wild West of the Current CBD Hemp Industry
The FDA is still in the process of determining exactly how to handle CBD products. While this is happening, it is vital that the industry takes responsibility for getting educated on existing rules and regulations and self-regulating.
An example of this was an FDA letter sent out just this week to a Florida-based Hemp CBD company warning them about marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease.
Warning letters sent are not an indication that people have not found CBD hemp products to be helpful for various health conditions. Rather, the warning letter is an indication that more studies must be done in order to obtain FDA approval and prove that health claims can be made. Meanwhile, it is up to consumers to educate themselves on their body, health, and nutrition.