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Jennifer Whetzel

Eating Your Words: How to Avoid Legal Issues Marketing Cannabis Consumables

By Jennifer Whetzel
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Jennifer Whetzel

Selling in a grey market isn’t for the faint of heart. You have to deal with the stigma surrounding your products and services, the potential for legal troubles, along with bureaucratic hurdles that all businesses face.

Acceptable marketing language surrounding consumable THC and CBD products encapsulates all of these issues, and it’s why everyone in the industry needs to pay close attention to what they’re saying. One innocent turn of phrase could have the Food & Drug Administration (FDA) shut down your business faster than you can say, “Oops.”

Avoiding this fate means making some adjustments to how you think about your marketing language, but this knowledge quickly becomes rote. Take a moment to learn how to protect yourself so that you can run your business rather than run afoul of the law.

Food, Drugs and Dietary Supplements

Scroll through Instagram for a few minutes and you’ll encounter a deluge of companies making claims about cannabis and CBD products. Many, if not most, are going about it incorrectly. Part of the confusion surrounds the fact that under the FDA’s rules, foods, drugs and dietary supplements are treated differently.

FDAlogoHow does the FDA decide what’s what? Based on how you advertise the product. If labeling suggests the substance is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or is an “article” (other than food) intended to affect the structure or any function of the body of man or other animals,” the FDA will regulate it as a drug.

The language and regulations surrounding drugs are extremely strict. On December 20, 2018, the FDA put out a statement reiterating that these rules are in effect for cannabis products. In other words, you can only make a drug claim if you have received approval from the FDA on your New Drug Application (NDA). Since approval requires hundreds of millions of dollars worth of clinical trials, this option is out of reach for most companies.

The rule states that you may not say that your product diagnoses, cures, mitigates, treats or prevents any disease, or any recognizable symptom of a disease. Disease is defined as: damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunction it (e.g. hypertension). Examples of diseases would include cancer, multiple sclerosis, epilepsy, autoimmune diseases, Lyme disease and more. In other words, you couldn’t say your product “prevents memory loss due to Alzheimer’s” or “treats symptoms of fibromyalgia.”

If you’re making any claims about curing anything in your cannabis business name, product name, packaging, web copy, advertising or marketing materials, you are at risk for breaking these rules and getting caught. The FDA’s regulations dovetail with the Federal Trade Commission’s truth-in-advertising laws, which state that your claims must be backed by legitimate research (such as peer-reviewed journal articles or double-blind studies) and must not mislead consumers. These rules are already being enforced within the cannabis industry, so pay close attention to what you’re putting out there.

An example of a warning letter the FDA sent to a CBD products company making health claims

However, you can’t avoid penalties by using this kind of language and claiming your product is a dietary supplement or food, either. According to the FDA, products that contain THC or CBD cannot be sold as dietary supplements. Their reasoning for this decision is that THC and CBD are active ingredients in FDA-approved drugs, such as Epidiolex and Dronabinol. Active ingredients in approved drugs may not be introduced into the food supply as dietary supplements or otherwise.

The language rules surrounding food can be equally complex. Foods approved by the FDA can make nutritional claims about how a nutrient impacts the structure/function of the body, such as “Calcium builds strong bones.” The problem for cannabis products is that these statements need to be authorized or qualified by the FDA and have significant scientific evidence and consensus. However, this consensus doesn’t exist for THC and CBD, meaning that you’re barred from making these kinds of claims.

Note that these rules don’t just apply to human supplements. They also apply to ones for pets. Many people don’t realize that a supplement for a pet is considered an “illegal drug of low regulatory concern.” But if you add in THC or CBD, a supplement becomes an illegal drug of—you guessed it—higher regulatory concern.

At a Loss for Words?

By now, you may be wondering what you can actually say to market your product; it may feel as though there are more restrictions than guidelines. Fortunately, the FDA hasn’t left us completely out at sea.

Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. The FDA published a final rule in the Federal Register in 2000 defining strict rules that govern the types of statements that may be used on a label without prior review of the agency. These are called structure/function claims. According to the FDA, “Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.” In contrast, statements that claim to diagnose, cure, mitigate, treat or prevent disease require prior approval by the FDA and are only for products that are approved drugs. Don’t use any of those words. Ever.

You can use the following words in your cannabis product names, advertising or marketing, as long as you’re not connecting them to a disease state: restore, support, maintain, raise, lower, promote, regulate, stimulate. You must specifically state that the claim relates to a non-disease condition; otherwise, you’ll be in trouble with the FDA. To go back to an earlier example, you cannot say that your product “prevents memory loss due to Alzheimer’s.” However, stating that your product “helps maintain a healthy brain” is fine.

Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. Following these rules does more than keep our enterprises out of trouble. It reinforces the idea that our industry is responsible, legitimate, and—perhaps most importantly—here to stay.

How Science Is Going To Save Your Cannabis Business

By Kay Smythe
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Marketing cannabis and the products that accompany recreational use is set to become one of the biggest industries in the United States. With 29 states promoting legal medical cannabis, 14 with it decriminalized and 8 having legalized it completely, you might be thinking this will be the easiest ad-campaign of all time. Unfortunately, science suggests otherwise.

The Science of Marketing

You heard correctly, marketing is a science, but almost half of what we know about the process cannot be applied to cannabis. Why? Because cannabis lives in the grey area of the American psyche. How do I know this?

Science.

In 2015, I completed and published The Safe Haven theory, a socio-demographic linguistic analysis of attitudes toward recreational drug use in the United Kingdom. I won’t bore you with the intricacies of the study, but the findings are important.

The study, using theoretical sociological trends, found that even non-recreational drug users in the United Kingdom favor cannabis legalization. A great number of police jurisdictions have chosen to not longer punish cannabis users, meaning that the law is (mostly) on our side – the side of full legalization and taxation of cannabis as a product for recreational usage, not so dissimilar from alcohol.

In the UK, we could easily put a huge billboard of someone’s grandmother smoking a spliff and make a million on the first day.

Unfortunately, the same can’t be done in the United States.

Advertising law aside, Americans just don’t have the same view of cannabis as Brits. In the last two years, I applied the same framework to a host of American demographics, and – as I hypothesized – localism rules the American market.

If you live in a Red town and you’re a recreational cannabis user, stigma will prevail over the scientific data, and changing that stigma is almost impossible without hard scientific evidence to back-up the marketing campaign.

Qualitative research is key when understanding why people buy into particular industries. This might not be the general belief held by most folks in advertising, as stats and numbers are distinctly easier to work with. However, as last year’s General Election and Brexit vote showed: numbers can lie. Therefore, the best means of understanding what people really want is to actually talk to them – and I mean in-person.

Marketing rules are shifting. More and more, the heads of marketing departments are turning to scientific and scholarly data to assess the current trends in social development, molding their campaigns around this data as a means of showing that they are industry leaders in understanding the phenomena, as well as speaking to target buyers in their own language.

Am I being too wordy? Let me put it simply.

Say your new product is an indoor indica strain with sleep/stress aid properties, this is how you should market it to three specific demographics:

  • Californian recreational smoker in the 50+ age demographic with a moderate knowledge of cannabis strains, “Indoor indica, grown locally with minimal chemical input, good as a sleep aid and positive for stress reduction.”
  • New York medical user, 30+, business background, “This strain is an excellent sleep aid, can decrease stress without taking off the edge of your day-to-day workload; highly recommended for those employed in a full-time, private sector position.”
  • Small town with predominantly low-income demographic employed in blue-collar industry, “affordable means of relaxing after a tough day at work that won’t give you the same cancer risk as tobacco.”

We market the same strain to each of these demographics, but the language used in the campaign is more important than the product itself. In the UK, the same strain would be marketed across the country using something like:

“Dank strain with sleep aid and relaxation properties, best for chilling out at the end of the day – definitely not recommended prior to work!”

What this means for the United States cannabis marketing specialist is simple: you need to invest as much as you can in getting scholarly researchers out into the field and figuring out the local socio-demographic linguistic trends for your target buyers. Luckily, this can be a fairly affordable means of research.

Marketing specialists have two options in uncovering this data:

  • Use students currently enrolled in universities and colleges, either offering paid internships or college credit for bulk research.
  • Hire an academic consultancy corporation. This is rapidly becoming a norm in for companies looking to expand their marketing by using scientific data, particularly in industries related to sport and the outdoors.

Just like how Pepsi really missed the mark with their latest failed advertising campaign, cannabis companies are at significant risk of ostracizing themselves from a wealth of demographics that would otherwise be open to recreational or medical cannabis use as an alternative to harsh pharmaceuticals, alcohol and even some forms of therapy.

Language is key, and if you can’t talk to your buyers on their level then you’ve already lost your edge over the competition.

Pennsylvania Temporary Rules for Doctors Released

By Aaron G. Biros
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Pennsylvania Department of Health Secretary Dr. Karen Murphy recently released a draft of temporary regulations for physicians, asking for feedback via a survey from the medical community. “The process for a patient to obtain medical marijuana will begin with the physician, so it’s vital to ensure that our regulatory process for those physicians is open and transparent,” says Secretary Murphy. “Our focus remains to implement a patient-focused medical marijuana program that gives help to those who need it, and these temporary regulations mark an important step forward in achieving that goal.” The temporary rules, published on April 11th, outline physician and practitioner registration, patient certifications, physician training and other key regulations.

Steve Schain, Esq. practicing at Hoban law Group

In the temporary rules lie some stipulations for doctors, which seem intended to limit corruption or financial conflicts of interest. According to Steven Schain, Esq., consumer finance litigation, banking law and cannabis law expert practicing with Hoban Law Group, the market’s growth will hinge on doctor participation. “The entire program will rise and fall based on the speed in which we involve doctors,” says Schain. “If the doctors don’t certify for medical conditions and make recommendations, the market won’t go anywhere.” Pennsylvania’s program, under the current language, requires doctors to issue patient certifications, similar to what other states might call a doctor recommendation or prescription.

According to Schain, other states with similarly worded regulations experience a lack of physician participation, and tepid market growth at best. “If you look at New York, New Jersey or Maryland, they run into issues where there just is no incentive for doctors to participate,” says Schain. “If you look at the existing language of the regulations, there is no financial incentive for doctors to get involved, they can’t charge for a recommendation, which is good and bad.”

“The good part is it reinforces that doctors can’t really be a financial backer of a grow operation or a dispensary,” says Schain. Under the current language, physicians can’t solicit, accept or offer any form of compensation from any patient, prospective patient, caregiver or anyone involved in a medical cannabis business if they intend to register with the Department to issue patient certifications for cannabis. “Some doctors thought this would be a cottage industry for them, it’s not.” Doctors are also not allowed to advertise as a practice issuing patient certifications for cannabis. “Another benefit of the language in the proposed regulations is the continuing care of a physician,” says Schain. “They want the people doing the bulk of referring or recommendations to be primary care physicians. Those are the people doing most of the recommendations, as it should be.” 

Those rules contrast starkly with what many are familiar with in California’s regulations where doctors could advertise freely and charge fees without the need for ongoing care. “Looking at previous regulations in a state like California, where there were no requirements for ongoing care, we saw doctors making a business out of writing recommendations for cannabis,” says Schain. “The PA regulations are much stricter, which I think is great.”

In addition to those preventative measures, the temporary rules require physicians to actively use the Prescription Drug Monitoring Program. This means doctors must consider a patient’s history of controlled substance prescriptions to see if that might impact their medical cannabis use. Doctors have to take this into account before issuing or modifying a patient certification. The rules also provide for a 4-hour training course, required for all physicians seeking to register as a practitioner who can certify patients for medical cannabis use. The Department of Health expects the program will be fully implemented by 2018.