Everybody Else Is Doing CBD, So Why Can’t We?

Sep 27, 2019

How many times has any parent heard the familiar lament, “Everybody else is doing it!”  Usually, that feeble protest is met with a definitive response along the lines of “That doesn’t make it right.”  And, usually, that’s the best answer – especially when it comes to CBD.

Anyone who attended this year’s Natural Products Expo West in Anaheim, California or Expo East in Baltimore, Maryland knows that CBD products seemed to be just about everywhere.  Some exhibitors even claimed that their products were “fully compliant.”  That is an interesting assertion given that the FDA has expressly stated that CBD cannot be used as an ingredient in foods or dietary supplements.  With regard to food, any substance that is intended to be a component of a food is a food additive, making it subject to premarket approval by the FDA unless it is already generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use.  CBD does not enjoy GRAS status.  Similarly, the FDA has concluded that CBD products are excluded from the dietary supplement definition under the Food, Drug & Cosmetic Act (Act) because CBD is an active ingredient in an existing drug, Epidiolex, a prescription medication intended to treat seizures.

While certain states may have looser views as to whether CBD can be used in those products, they do not trump the Act or the FDA.  In other words, nothing is actually prohibiting the FDA from taking enforcement actions against manufacturers or distributors of CBD-containing food and dietary supplement products.

But, wait!  What about major retailers’ recent announcements that they would be carrying “topical” products in various states across the country?  This product category includes creams, sprays, roll-ons, lotions, salves and soap.  That doesn’t sound like a drug, food or dietary supplement.  “Topicals” sounds like … uh … cosmetics!  That must be okay, right?  Well, let’s take a look at the overarching Act to see if that conclusion holds up.

The Act defines “cosmetics” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance….”  Act, sec. 201(i).  Products generally deemed to be cosmetics include skin moisturizers, perfumes, lipsticks, shampoos, deodorants, and so on.  On the surface, this seems to be the general category that “topicals” fall into.  However, whether a product is a cosmetic or a drug under the law is determined by a product’s intended use.

The Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals….” Act, sec. 201(g)(1).  Products such as prescription medicines or flu vaccines, for example, are clear examples of drugs.

Wait, what?  Some products meet the definitions of both cosmetics and drugs?  Yes.  This happens when a product has more than one intended use.

So, how is a product’s intended use determined?  As with most straightforward questions, the legal answer is “it depends.”  The intended use can be indicated by the claims stated on the product labeling, in advertising, on the Internet, or in other marketing materials.  The intended use can also be establishing by consumer perception of what it is used for and/or the product’s marketplace reputation.  Additionally, if a product has a well-known therapeutic use, that can establish it as a drug (e.g., fluoride toothpaste).

An example provided by the FDA on its website to illustrate this point would be that of a shampoo.  It is a cosmetic because it is intended to clean hair, but if it is also formulated to treat dandruff, it would also be considered a drug.

“Okay, but so what?” you are probably asking.  Manufacturers just need to be careful about identifying their CBD products’ intended uses.  Not so fast.

If a manufacturer is not careful about the claims made on its product’s label and associated labeling (such as a website), what the manufacturer intends its products to be used for might not hold up.  Under the Act, drugs must generally either receive premarket approval by the FDA through a New Drug Application (NDA) process or conform to a monograph for a particular drug category.  These monographs specify  the conditions under which over-the-counter drug ingredients are generally recognized as safe and effective.  CBD does not currently enjoy this classification.

“Well, what about the Farm Bill?” you ask.  An overly broad reading of that legislation has not been endorsed by the FDA when it comes to CBD.  In a December 2018 statement following the passage of the Farm Bill, the FDA expressly noted:

In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.


And, we should talk about soap.  The regulatory definition of “soap” is different from the way in which people commonly use the word.  The regulated term “soap” only applies when:

  • the bulk of the non-volatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
  • the product is labeled, sold, and represented solely as soap.  (21 CFR 701.20).


“Soap” products that meet this definition are regulated by the Consumer Product Safety Commission (CPSC).  If a product intended to cleanse the human body does not meet all the criteria for soap, it is considered to be a cosmetic (and, if you are not careful, it might also be a drug).  Which puts us back in line with the regulatory chutes and ladders process that I outline above.

The takeaway?  While a major retailer may be willing to push the issue in an effort to meet consumer demand, it is important to remember that retailers have no law or rule making authority.  Whether the FDA takes more concerted action to stop or otherwise question the sale of CBD products at retail stores remains to be seen.  However, what cannot be reasonably disputed is that many of those products are not likely in compliance with the Act or FDA guidance at this time.  Therefore, just because everyone else seems to be diving in head first, doesn’t mean that you should be.

Man watching another man diving into water

FDA Continues to De(lay)Regulate Nutrition Facts: Postpones Food Manufacturing Label Deadline

May 04, 2018

We previously wrote about when the FDA postponed restaurant nutritional labeling requirements at the 11th hour. In Act II today, the FDA extended the compliance date for food manufacturers to update their nutrition labels by eighteen months.

Different Administration, Different FDA

In 2016, under the Obama Administration, the FDA published two final rules: the “Nutrition Facts Label Final Rule” and the “Serving Size Final Rule.” The Obama FDA set the deadline for compliance with these two rules for July 2018 for manufacturers with $10 million or more in annual food sales and for July 2019 for manufacturers with less than $10 million.

In June 2017, the FDA under the Trump Administration announced an indefinite delay in the launch of these initiatives. The FDA published a final rule on May 4, 2018, extending the deadline “in response to concern that companies and trade associations have shared with us regarding the time needed for implementation of the final rules and the need for FDA to provide further guidance to manufacturers subject to the final rules.” The  new compliance deadline is now January 1, 2020 for manufacturers with $10 million or more in food sales, and manufacturers with less than $10 million get even more time – until January 1, 2021 – to comply.

The Nutrition Facts Label Final Rule was intended to “improve how the nutrition information is presented to consumers” to “help consumers maintain healthy dietary practices.” It required manufacturers to make a number of changes to their labels including providing more detailed information regarding calories and nutritional context in the form of Daily Reference Values.

The Serving Size Final Rule was intended to “ensure that serving sizes are based on current consumption data and to provide consumers with information on the Nutrition Facts label related to the serving size that will assist them in maintaining healthy dietary practices.” It required all containers over a minimal threshold of Reference Amounts Customarily Consumed (in my house an entire can of Pringles or a pint of Three Twins ice cream) to be labeled as a single-serving container.

Keeping Today’s FDA Action in Perspective

While intense lobbying from some food and beverage industry trade groups has resulted in the delays to changes in the Nutrition Facts Panels and serving sizes, not every manufacturer has been sitting idly by. Manufacturers of all sizes have been early adopters in implementing these changes. When you go to the grocery store, take a little extra time to review the packages of the foods that you routinely buy. Chances are, you will see a mixture of new and old Nutrition Facts Panel formats.

While consumers and health advocates see the delays as a significant public policy gaffe by the FDA, FDA Commissioner Dr. Scott Gottlieb has stated that the FDA will be implementing other changes previously championed by the former Obama Administration such as sodium reduction targets for food products, and caloric disclosures on chain restaurant menus. According to the FDA, the changes that consumers will see are intended to educate everyone as to the link between diet and chronic diseases such as obesity and heart disease. Wherever you fall on the “need” for these rule change delays, gaining a better understanding that what we eat matters is a healthy goal for all of us.


What’s In Those Brownies Anyway? What You Need to Know About California Cannabis Edibles Regulations

Feb 14, 2018

With adult use of cannabis now legal in California as of January 1, 2018, some food companies may be considering adding “edibles” – cannabis-infused products that are intended for human consumption – to their product lines.  According to Forbes, edibles may account for more than half of the growth in the booming cannabis industry, as high-end food products infused with cannabis and cannabinoids are growing in demand for the discerning consumer who cares not only about the high, but also taste and quality.

But with legalization comes regulation, and the California Department of Public Health has issued emergency regulations detailing what is and isn’t allowed in manufacturing and selling edibles. Among the regulations are stringent requirements for THC content per serving and per package, and packaging and labeling requirements.

Here are some key things to know about manufacturing and selling edibles under the new California regulations.

Prohibited Products

There are certain things that you just can’t make into and sell as edibles.  Alcoholic beverages, dairy products, meat (other than dried meat) and seafood are out.  Products that have to be kept below 41° Fahrenheit to make them fit for human consumption are also out, as is juice that is not shelf-stable.  Products with additives such as nicotine or caffeine that would increase potency, toxicity or addictive potential, or that would create an unsafe combination with psychoactive substances, are prohibited.  But a product that has naturally-occurring caffeine, like tea, coffee or chocolate, is fine.  You can’t add cannabinoid concentrate or extract to commercially available candy or snack food with no further processing, and products that are easily confused with commercially available food products that do not normally contain cannabis are prohibited.

Don’t Make Them Appealing to Children

A big concern addressed by the regulations is preventing children from accidentally ingesting cannabis edibles.  To that end, manufacturers of cannabis edibles can’t make products that might be attractive to children.  Edibles that are shaped like a human, animal, insect or fruit are specifically prohibited.  If you are going to make cannabis gummies, for example, don’t make them look like gummy bears and don’t call them “candy.”    The terms “candy” or “candies” can’t be used.  The label and packaging can’t contain content that imitates candy packaging or labeling, or include anything that might appeal to children, such as cartoons or other images, characters, or phrases popularly used to advertise to children.  Finally, the packaging itself has to be child resistant and can’t look like packaging used for products typically marketed towards children.

THC Content and Servings

The regulations limit the amount of THC (tetrahydrocannabinol, the chemical compound in cannabis responsible for a euphoric high) that can be in edibles. Edibles may not contain more than 10 milligrams of THC per serving and 100 milligrams of THC per package.

Edibles have to be packaged so that a consumer can accurately identify a single serving.  Products that contain more than one serving have to be scored or delineated to indicate a single serving, if it is in solid form.  If it is not in solid form, it has to be packaged in such a way that a single serving is readily identifiable. For example, if selling a cannabis-infused drink, you may want to include a dosage cup similar to what comes with cough syrup. Each serving in a multi-serving package has to contain about the same amount of THC.

All product ingredients or components, other than the cannabis, cannabis concentrate, or terpenes, must be permitted by the U.S. Food and Drug Administration (FDA) for use in food or food manufacturing (Everything Added to Food in the United States).

Packaging Requirements

The packaging for edible cannabis products must:  (1) protect the product from contamination, (2) be tamper-evident, meaning that it is sealed so that it cannot be opened without obviously breaking the seal, (3) be child-resistant, (4) not imitate packaging for products typically marketed to children, (5) be opaque, and (6) if containing more than one serving, be re-sealable so that child resistance is maintained.

Labeling Requirements

If you are a food manufacturer, you know that making sure your labels are compliant with FDA regulations is important.  It is no different under the California regulations for edible cannabis products.  The labeling on packages of edibles must have two components:  a primary panel and an informational panel.

The primary panel must include:

  1. The identity of the product in a text size reasonably related to the most prominent printed matter on the panel, and the words “cannabis-infused” immediately above in a text size larger than the text size used for the identity of the product;
  2. The universal symbol as shown below, printed conspicuously and legibly, not less than a half inch by a half inch;
    CA Cannabis symbol
  3. Net weight or volume of the contents; and
  4. THC and CBD (Cannabidiol, the non-psychoactive cannabis compound) content of the package, as well as the THC and CBD content per serving, all expressed in milligrams.

The informational panel must include:

  1. Name and contact number or website address of the manufacturer;
  2. Date of manufacture and packaging;
  4. If for medicinal use, the statement “FOR MEDICAL USE ONLY”;
  5. A list of all product ingredients in descending order of predominance by weight or volume;
  6. If the product contains a major food allergen, the word “contains” followed by a list of such allergens;
  7. The names of any artificial food colorings contained in the product;
  8. The amount, in grams, of sodium, sugar, carbohydrates, and total fat per serving;
  9. Instructions for use, such as the method of consumption or application, and any preparation necessary prior to use;
  10. The product expiration date, “use by” date, or “best by” date, if any; and
  11. The UID (the unique identifier for use in the track-and-trace system established by the Department of Food and Agriculture) and, if used, the batch number.

The label can’t contain any claims that the cannabis was grown in a California county if it was not actually grown there and can only name the California county in which it was actually grown.  The label can’t have any false or misleading information, and can’t make any health-related claims that are untrue or misleading. However, the label can include a statement of effects – information on the characteristic anticipated effects if the manufacturer has substantiation that the information is truthful and not misleading, as long as there are no claims of health benefits.

Other Considerations

It’s important to note that cannabis is considered a controlled substance under the federal Controlled Substances Act, and despite legalization in California, trafficking in cannabis, including the manufacture and sale of  edible cannabis products, remains illegal under federal law.  Possible negative consequences, including federal criminal prosecution and tax liability, still exist. Along with the requirements outlined here, there are other requirements under California law with regard to obtaining a manufacturing license, testing, advertising, distribution and sales of edible cannabis products. It’s a brave new world of legalized cannabis in California, but before jumping in, it is important to first seek legal advice and to proceed with caution.


Food for Thought: 10 Considerations For Food and Beverage Companies In 2018

Jan 24, 2018

Wendel Rosen’s Food and Beverage Practice Group provides a full range of services to producers, manufacturers, distributors, suppliers, growers, retailers and investors, as well as to the broader consumer packaged goods industry. Heading into 2018, we believe that food and beverage companies should keep the following considerations in mind:

  1. Regulatory Oversight. It is still not clear what the Food and Drug Administration’s (FDA) focus will be with regard to its regulatory enforcement strategy under the Trump administration. While the FDA rolled back certain regulations to allow for greater time for industry compliance (ex. new Nutrition Facts Panel and restaurant nutritional disclosure regulations), the FDA will likely pay more attention to enforcing the Food Safety Modernization Act regulations. Therefore, a focus on your company’s compliance with food safety regulations is a must.
  2. Changing Consumer Preferences. Staying on top of shifting consumer preferences is essential for relevant food and beverage companies. Healthy snacking options and increasing convenience in both food packaging and delivery are gaining significant traction in 2018. The lack of time for meal preparation continues to drive an increase in convenient foods, but consumer awareness also demands that such foods be nutritious and delicious alternatives to the home-cooked meal. While every trend may not apply to your business, prudent food and beverage companies should prioritize analyzing available market data to ensure they  understand the driving preferences behind consumer purchasing decisions.
  3. Recalls. Recalls are time consuming and costly events. Since 2011, Class I and Class II recalls have steadily increased. Food and beverage companies should continually review their food safety programs to effectively educate and train employees, conduct internal audits, and improve their food safety/quality systems. In doing so, they will greatly reduce the risk of a voluntary market withdrawal or a mandated recall.
  4. Social Media. The genie is out of the bottle, and food and beverage companies must have a strategy to retain control of their brand image in our increasingly digital world. Food and beverage companies should proactively develop strategies to effectively communicate about their products and manage user engagement to maintain a positive consumer expression about their brands.
  5. Mergers and Acquisitions. Mergers and acquisitions will continue to serve as a growth strategy for companies looking to bring new, on trend products to the marketplace. Acquisitions of smaller companies who are leading market food and beverage trends can be done at a lower cost than spending the time and resources in experimenting with new products.
  6. E-commerce. With Amazon’s acquisition of Whole Foods, e-commerce will continue to grow in 2018 as busy consumers will likely show increasing interest in quicker and/or home delivery.  Consumers will continue to integrate ordering from their mobile devices into their monthly routine of in-store shopping.  Food and beverage companies should look to find ways to expand their direct-to-consumer sales and/or third-party e-commerce platforms to increase their sales and market position.
  7. Technology. Technological change will accelerate in our food systems from the way food is grown to the way it is purchased and delivered. At this year’s Fancy Food Show we saw how the supermarket of the future may look, as well as how technology can provide consumers with greater transparency and more complete information that they can use to inform their purchasing decisions. Food and beverage companies need to understand what such transparency could mean for their brands and how they can meaningfully communicate with consumers.
  8. Disruption. From plant-based foods challenging “traditional” food concepts in the meat and dairy categories to hydroponic farmers challenging what foods can be certified organic, disruption continues to intensify. It is no longer enough to consider “how” something is done, but also “why” it is done. Entrepreneurs are emerging who are looking to explore the beneficial intersection of food science and technology to advance the sustainability and health of our global food supply. Food and beverage companies clinging to the status quo, beware.
  9. Plant-based foods. The consumer diet is shifting to accommodate more plant-based foods. According to the market research firm Mintel, the preference for natural, simple and flexible diets will continue to drive an array of vegetarian, vegan and other plant-based food products.
  10. Have fun!  While food safety and food quality are serious concerns of any responsible food and beverage company, don’t take yourself too seriously. The food and beverage industry still affords you meaningful consumer engagement opportunities, access to innovative technologies, and the venue to introduce exciting products that will be on supermarket shelves and in consumer pantries. Throw in the industry trade shows, networking opportunities, and professional growth opportunities and you quickly realize that the industry is FUN. (So, get out there and start enjoying it – we’re right here when you need us.)

New Year’s Resolution – Avoid Class Action Lawyers

Jan 23, 2018

Is it odd for a lawyer to write a blogpost about how to avoid lawyers?  Not at all. We hate to see claims of misrepresentation made against our clients by plaintiff’s class action attorneys. Typically, their claims have little merit and mean only wasted time, money and energy.

The goal of the class action attorneys is to extract the largest ransom with the least work. Anyone with a computer can generate rafts of “cut and paste” demand letters and complaints. They usually try to exploit vagueness in the law, often using professional plaintiffs who show up in scores of copycat lawsuits.

Enough diatribe! Your New Year’s resolution should be to stay away from class action attorneys in 2018. Here are some guidelines that will help you do that. We’ll have more posts on the subject as the year progresses.

Prop. 65: California Prop. 65 requires that you make disclosures on your labels if your product contains more than specified limits of identified chemicals. If you are selling in California, look at the list of chemicals on the Prop. 65 list. Now find a qualified lab that can test samples of your product runs for Prop. 65 chemicals and get the testing done. I can assure you that if your product category (chocolate – for example) is known for having trace elements of Prop. 65 chemicals, there are plaintiff’s lawyers who are testing your product. You should know the results of those tests before they do. If your product does have amounts of these chemicals that require Prop. 65 notices, it may be cheaper to put notices on your packages than it is to reformulate. It will certainly be cheaper than settling a class action claim for failure to include a Prop. 65 notice.

“Natural”: “Natural” is an accepted term to describe the marketplace. The largest industry event is “Natural Products Expo West.” The main retail publication is the “Natural Foods Merchandiser.” Food stores, whether independent or parts of a chain,  are referred to as “Natural Food Stores.” However, just because “natural” is used by the industry and the public to describe minimally processed foods does not mean it should have a home on your label. There’s no legal definition of “natural.” In 2015, in response to industry requests, the FDA asked for comment about whether “natural” should be defined and, if so, how. After receiving many comments, the FDA did nothing then. Last year, FDA Commissioner Dr. Scott Gottlieb said that the FDA is now looking at how to define “healthy” and “natural” more uniformly. “Natural” claims are one of the largest source of class action suits. Until “natural” has a clear legal definition and you are sure that your product meets it, don’t put the word on your label. It’s as simple as that.

“Healthy”: Is your product healthy? Of course it is. Would you be selling a food product that is unhealthy?  Of course not. Would you be advertising “Now, Even More Unhealthy In Convenient Family Pak?” Of course not. Unlike “natural,” the FDA does have a definition for “healthy.” However, the definition must be used carefully. It is out of date, contrary to current nutritional science and is under review. The FDA is reconsidering the definition and, last year, agreed that KIND bar could continue using “healthy” on its labels even though KIND bars exceeded the amount of fat allowed in the FDA definition. Our best advice is not to use the word “healthy” until there is a new definition. However, it you feel compelled to use it, find out if your product satisfies the requirements.

That’s it for now. I hope this New Year’s resolution comes true for you. See you at the Specialty Food Show or EXPO West.


Where Is The Love?

Oct 24, 2017

On September 22, 2017, the U.S. Food & Drug Administration (“FDA”) issued a warning letter to Nashoba Brook Bakery for what it puts into its granola: love. The FDA was not impressed, coolly advising that “love” is not a common or usual name of an ingredient. Now, before you write the FDA off as a “hater,” let’s consider the role that food labels serve.

The primary role for food labels is to provide consumers meaningful information about a food so that they can understand what they are about to put into their bodies. Mandatory label statements include the name of the food, the amount of product in the package/container, the name and address of the manufacturer, packer or distributor, the ingredient list, nutrition labeling and any required allergy disclosure. To ensure that a consumer can readily understand a food’s attributes, the FDA requires that manufacturers always list the common or usual name for ingredients unless there is a regulation that provides for a different term.

The FDA’s strict stance on fastidious compliance with food labeling, though, should not be dismissed as an example of bureaucrats with no senses of humor. The FDA’s mission (one might even call it a passion) is to protect consumers’ health and safety. Even a cursory review of the warning letter to Nashoba Brook Bakery clearly reveals that listing “love” as an ingredient was just one of many other serious violations, including the failure to maintain the bakery in a sanitary condition.

In truth, with a better understanding of the regulations applicable to food labeling, love is not lost for Nashoba Brook Bakery. Food labels can, and often do, carry optional statements known as “romance copy.” (You didn’t see that coming, did you?)  Romance copy is comprised of the statements extolling the virtues of a product, or providing the backstory on the manufacturer. If there is any place on a label for an expression of love, that’s where this food attorney recommends food manufacturers make it. Put “Made with Love,” “Filled with Imagination,” “Packed with Magic,” or “Created with Passion” in the romance copy, just don’t list love, imagination, magic or passion as an ingredient.


FDA Recalls FDA Menu Regulations

May 18, 2017

FDA watchers may have experienced whiplash last week as the FDA did an about face and postponed restaurant nutritional disclosure regulations that were years in the making.

In 2014, under the Obama Administration, the FDA enacted regulations that required chain restaurants to disclose “certain nutritional information for standard menu items” to “enable consumers to make informed and healthful dietary choices.” The FDA noted that “two thirds of adults and a third of the children in the United States are overweight or obese” and that “[m]any people do not know, or underestimate, the calorie and nutrient content of…foods from restaurants and similar retail food establishments.” Restaurants and other covered establishments were required to comply with these regulations no later than May 5, 2017. The National Restaurant Association had supported the FDA’s efforts to create a “nationwide federal menu labeling standard….”

But at the eleventh hour, on May 4, the Trump Administration’s FDA postponed the compliance date to May 7, 2018, so the FDA could “consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives….” The Trump FDA not only postponed the compliance date, but also reopened the comment period, giving the public/other interested parties 60 days to provide public comment.

One suspects the restaurant industry must feel like high school students whose teacher just announced that tomorrow’s midterm was just rescheduled from this Friday to probably never.