Food and beverage industry, if you haven’t already, now is the time to review your websites.  I have noticed an uptick in litigation against businesses for allegedly not having an Americans with Disabilities Act (ADA) compliant website.  Even though the ADA does not expressly mention websites, nor is there any legally established standard (yet) about what is a compliant website, the courts have interpreted the ADA to extend to websites.  However, what is known is that covered businesses must provide an accessible website that accommodates disabled users.

So, what’s a covered business?

Generally speaking, businesses falling under Title I of the ADA (i.e., companies operating 20+ weeks per year with 15+ full-time employees) or those that fall under the “public accommodation” category of Title III of the ADA (e.g., hotels, banks, public transportation, etc.) constitute covered businesses.  However, when it comes to websites, the courts are split regarding Title III’s definition of “public accommodations,” and in particular, whether that definition is limited to physical spaces.

Courts within the First, Second, and Seventh Circuit Courts of Appeals have found that a website can be a place of public accommodation independent of any connection to a physical space.  Carparts Distrib. Ctr., Inc. v. Auto. Wholesaler’s Ass’n of New England, Inc., 37 F.3d 12, 19 (1st Cir. 1994); Nat’l Ass’n of the Deaf v. Netflix, Inc., 869 F. Supp. 2d 196, 200 (D. Mass. 2012); Nat’l Fed’n of the Blind v. Scribd Inc., 97 F. Supp. 3d 565, 576 (D. Vt. 2015); Andrews v. Blick Art Materials, LLC, 268 F. Supp. 3d 381, 393 (E.D.N.Y. 2017); Morgan v. Joint Admin. Bd., Ret. Plan of Pillsbury Co. & Am. Fed’n of Grain Millers, AFL-CIO-CLC, 268 F.3d 456, 459 (7th Cir. 2001); Doe v. Mut. of Omaha Ins. Co., 179 F.3d 557, 558 (7th Cir. 1999).

On the other hand, courts within the Third, Sixth, Ninth, and Eleventh Circuits have held that places of public accommodation must be physical places, but that goods and services provided by businesses within this category by and through their websites may fall within the ADA if the websites have a sufficient nexus to a physical location.  Gil v. Winn-Dixie Stores, Inc., 257 F. Supp. 3d 1340, 1349 (S.D. Fla. 2017); Haynes v. Dunkin’ Donuts LLC, 2018 WL 3634720, at *2 (11th Cir. July 31, 2018); Robles v. Domino’s Pizza, LLC, No. 17-55504, 2019 WL 190134, at *4 (9th Cir. Jan. 15, 2019) (“This nexus between Domino’s website and app and physical restaurants…is critical to our analysis.”); Weyer v. Twentieth Century Fox Film Corp., 198 F.3d 1104, 1114 (9th Cir. 2000); Earll v. eBay, Inc., 599 F. App’x 695, 696 (9th Cir. 2015); Ford v. Schering-Plough Corp., 145 F.3d 601, 614 (3d Cir. 1998); Peoples v. Discover Fin. Servs., Inc., 387 F. App’x 179, 183 (3d Cir. 2010); Parker v. Metro. Life Ins. Co., 121 F.3d 1006, 1010 (6th Cir. 1997)).

Regardless of the legal differences among the circuit courts, my recommendation is to get in compliance without delay.  Voluntary compliance in keeping with the spirit of the law (i.e., providing access) can help you avoid costly litigation later on and it’s smart business.  Indeed, why wouldn’t you want more consumers being able to access your website?

Okay – so how do you comply?

As I mentioned above, there is a regulatory gap here.  However, the Web Content Accessibility Guidelines (“WCAG”) established by the World Wide Web Consortium is a private set of guidelines that set forth methods to improve the accessibility of a website or mobile app.  You may have heard of them, but if not, you can find more information about WCAG online.  At least one court has ordered a business to comply with the WCAG 2.0 Guidelines.  See Gil v. Winn-Dixie Stores, Inc., supra, 257 F. Supp. 3d at 1349.  (Although, the trial court ruling in Gil is up on appeal.)  Even so, businesses would probably be wise to determine whether their websites and mobile apps adhere to the most recent WCAG Guidelines 2.1 Level AA success criteria.  It’s likely cheaper to follow those guidelines than fight off an ADA compliance lawsuit.

Additionally, there are third party consultants who conduct ADA compliance audits for websites.  The consultant will likely follow WCAG guidance.  Some common fixes that a consultant might recommend include, but are not limited to:

• Creating alt tags for all images, videos and audio files to allow users with disabilities to read or hear alternative descriptions of content they might not otherwise be able to view. Alt tags describe the object itself and, generally, the purpose it serves on the site.
• Creating text transcripts for video and audio content.
• Specifying what language the site should be read in and coding accordingly. Text readers utilized by blind individuals identify those codes, which allows the readers to function properly.
• If a disabled user encounters input errors because of his/her need to navigate the website differently, the site should automatically offer recommendations to the user as to how to better navigate toward the content they need.
• Menus, links and buttons should be organized in such a way that they are clearly delineated from one another and are easily navigated throughout the entire site.

Remember, the ADA is intended to ensure that disabled persons are not discriminated against in accessing the places that non-disabled persons frequent without impediment.  Even so, ADA website compliance can be a potentially confusing undertaking.  Thus, consultation with industry experts and your legal team is a must to ensure that you get a more navigable and legally compliant website.

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.

“Krümel Monster Muffins” by Xitu is licensed under CC BY-SA 4.0

The regulatory status of a food ingredient is governed by certain bright line rules.  Any substance that is reasonably expected to become a component of food is a food additive.  A food additive is subject to premarket approval by the Food & Drug Administration (FDA) unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use, or it otherwise satisfies some other exclusion from the food additive definition in section 201(s) of the Federal Food, Drug, and Cosmetic Act (Act). Any food additive that is intended to have a technical effect in the food is deemed unsafe unless it either conforms to the terms of a regulation prescribing its use or to an exemption for investigational use.  Any food that contains an unsafe food additive is adulterated under section 402(a)(2)(C) of the Act.

However, when it comes to CBD, this regulatory framework gets lost in the minds of many businesses looking to gain a toehold in the marketplace.  In December, I wrote a word of caution regarding the passage of the Farm Bill and its meaning (or lack thereof) for CBD in food and dietary supplements.  The intervening months since the Farm Bill’s passage have proven to be interesting.  Confusion, whether caused by ignorance of the applicable laws and regulations or denial about the limitations of those controlling rules, seems to be the norm when it comes to CBD in food and dietary supplements. 

Whenever I tell an interested manufacturer or distributor that CBD is not an authorized ingredient in either category, I routinely hear familiar protests: “Well, how come I see other products proudly marketing CBD as an ingredient?  What about the Farm Bill – what if the CBD is from hemp?”  The short answer, of course, is that while the FDA has been facing calls to update its regulations in light of the Farm Bill, CBD is still not authorized by any federal law or regulation to be used in food or dietary supplements, which then informs state law and regulations, which are largely modeled on the Act.  The longer answer, though, is because cannabis study has been greatly controlled and stymied by the federal government, because regulators may not understand CBD and how it can be derived, and because the FDA has not begun to meaningfully crack down on CBD products apart from a few Warning Letters pertaining to unsubstantiated CBD claims, policing the market place has fallen upon individual states.  The absence of consistent policing efforts to date, in turn, may give the impression that CBD use in food and dietary supplements is acceptable.   That should not be the takeaway.  As policing efforts are picking up steam, a quick rundown of what is happening in a few nationally influential states might be helpful in clearing up what seems to be so commonly misunderstood:  CBD is not an authorized additive or ingredient in food and dietary supplements.

California

While a liberal state in many regards, California is following the FDA’s lead.  California Health & Safety Code Section 109935 defines “food.”  Excluded from that definition are products containing cannabis.  Thus, as a threshold step, California is not classifying edibles as food; rather, such products can only be sold at licensed cannabis dispensaries.

Additionally, the California Department of Public Health has squarely addressed whether industrial hemp-derived CBD can be used in food or dietary supplements:

California incorporates federal law regarding food additives, dietary use products, food labeling, and good manufacturing practices for food . . . . Currently, the United States Food and Drug Administration (FDA) has concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which tetrahydrocannabinol (THC) or CBD has been added. This is regardless of the source of the CBD – derived from industrial hemp or cannabis.  Therefore, although California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

New York

New York City regulators just took a bite out of the Big Apple’s CBD restaurateurs.  The New York Times recently reported that the Department of Health and Mental Hygiene confiscated one bakery’s CBD-infused goods, raw ingredients and CBD powder, and it has ordered all restaurants under its jurisdiction not to sell any food products containing CBD.  Although the bakery claimed that there was “a general lack of clarity” around the use of CBD in food, ignorance of the law is what really seems to have resulted in that uncertainty on the part of the bakery.  The regulators, on the other hand, seem clear eyed.

Texas

No, no, no.  Well, maybe.  That’s pretty much sums up Texas, which is considering legislation that would establish regulations regarding hemp cultivation.  Even so, Texas (like California) is following the FDA’s lead and it does not allow CBD in any food, dietary supplement or cosmetic.

Colorado

But – wait!  What about Colorado?!  Well, it is true that the Colorado Department of Public Health & Environment does allow use “of all parts of the industrial hemp plant” as a food ingredient “in Colorado.”  However, Colorado is not saying that CBD, in general, can be used as a food additive, nor is it suggesting that its policy is consistent with federal or other state law, and its permissive attitude regarding industrial hemp comes with strict conditions. 

In order for food to contain industrial hemp, a manufacturer must be able to demonstrate the following:

• All parts of the hemp plant utilized in food must come from a state that has an established and approved industrial hemp program or a country that inspects or regulates hemp under a food safety program or equivalent criteria to ensure safety for human consumption.

• The producer/grower must be in good standing and compliance with the governing laws within the state or country of origin.

• The industrial hemp must conform to the standard of identity established in C.R.S., §35-61-101(7) of no more than three-tenths of one percent delta-9 tetrahydrocannabinol (THC).

• The use of other parts of the hemp plant other than seed and its derivatives (seed meal, flour, and oil), must be lab tested to establish that THC levels are not above the allowable limit of THC.

• The product must be labeled in conformance with state and federal labeling laws, including:
  • clearly identify hemp as an ingredient;
  • clearly identify CBD and the amount of CBD if added as an isolate;
  • include the statement “FDA has not evaluated this product for safety or efficacy” and;
  • not contain any health or benefit claims.

• The producer must be able to document that the finished product does not contain more than three-tenths of one percent THC.

Colorado’s conditions are thoughtful, particularly as they relate to testing and identification, but they do nothing to insulate a manufacturer or distributor from the policies of other states.  What goes in Colorado does not mean that it will be accepted in other jurisdictions. Indeed, police in Idaho and Oklahoma have started seizing products being transported across state lines that they deem to be cannabis over the protests of the transporters who claim that the products are actually hemp and, thus, protected from such seizure.  But, that is a story for another post…

Given this brief overview of what some states are doing, I hope that everyone will please keep in mind that the Wild West-approach is better suited for movies.  No manufacturer, distributor or retailer should act with impunity or out of ignorance to the legal restrictions surrounding CBD and its use in food or dietary supplements.  While there are many people and organizations working to enact sensible policies, we just are not there yet. Until we are, we need to work within the law in an effort to cultivate the legitimacy necessary for the cannabis industry to thrive and grow.

I have said it before, and I will say it again: no, you cannot use CBD as an ingredient in food or dietary supplements. While some have touted the recent passage of the Agriculture Improvement Act of 2018 (aka, the Farm Bill) and its relaxation of the controls on the production and marketing of hemp as an implicit sign that it is acceptable to use cannabidiol (CBD) in food and/or dietary supplements, those fortune tellers are wrong. Yesterday, the Food & Drug Administration released an updated guidance document regarding its current positions on cannabis and CBD, in particular.

The FDA has expressly stated that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the Food, Drug & Cosmetic Act (the Act). If a substance such as THC or CBD is an active ingredient in a product that has been approved as a drug or that has been authorized for investigation as a new drug, then products containing such substances are outside the definition of a dietary supplement. According to the FDA, “[t]here is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”

With regard to food, the FDA has also provided unequivocal guidance:

Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.

While there are exceptions to this rule when the drug has been previously marketed as a food before the drug was approved or clinical investigations involving the drug was initiated, like dietary supplements, the FDA has concluded that none of these exceptions apply for THC or CBD.  Accordingly, the FDA has concluded that “it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.”

Given this clear guidance, I stand by my often provided advice to clients (and to those of you reading this blog):  CBD cannot be used in food or dietary supplements, and if you do so, you proceed at your own risk. The Farm Bill does not serve as any legal basis for the use of CBD-derived hemp. In fact, the Farm Bill expressly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds. Until the FDA approves the use of CBD, I would also caution against any rationalizing of the use of CBD that comes from hemp as opposed to cannabis. As the FDA notes, it has seen no evidence to change its current thinking on CBD, but it will consider any evidence to the contrary by interested parties. Thus, if you want to use CBD, do your homework, develop your evidence, and then work with your legal counsel to present your findings to the FDA so as to obtain approval of including CBD in your product before you release it in commerce.

My favorite Megan Mullally quote, and there are many, is her ode to coffee: “I’ll quit coffee. It won’t be easy drinking my Bailey’s straight, but I’ll get used to it. It’ll still be the best part of waking up.”

Wendel Rosen attorney, Wendy Manley, recently wrote about the new labeling requirements for coffee. As she noted, a California court recently determined that coffee must bear a warning under the state’s Safe Drinking Water and Toxic Enforcement Act (aka “Prop 65”) regarding acrylamide, a carcinogen found in low levels in coffee due to the roasting and/or brewing process. As it turns out, things may not be so dire after all, and coffee lovers may soon raise a mug to celebrate California regulators.

On Friday, June 15, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to add a new section of the California Code of Regulation, stating that no significant risk of cancer is presented by drinking coffee. OEHHA is the lead state agency that implements Prop 65 and has the authority to promulgate and amend regulations pertaining to it. Citing to the International Agency for Research on Cancer (IARC) in its press release, OEHHA justified its proposed regulation, in part, on the IARC’s conclusion that drinking coffee does not present a significant risk of cancer. Thus, while acrylamide is designated as a probable human carcinogen, a cup of joe is not considered to be, according to IARC research.

This conclusion isn’t surprising to the coffee industry. In 2016, the cancer agency of the World Health Organization removed coffee from its “possible carcinogen” list, and there have been numerous published studies touting the potential health benefits of drinking coffee over the years.

OEHHA maintains that its proposed regulation will benefit “the health and welfare of California residents by helping to avoid cancer warnings for chemicals in coffee that do not pose a significant cancer risk.” One can’t help but wonder, though, if this regulatory about face is intended to benefit Prop 65, too. As reported in Law360 (a subscription is required), a bipartisan group of members of the U.S. Senate and the U.S. House of Representatives may be looking to undermine labeling requirements on the federal, state and local levels, and in particular, Prop 65, by requiring that labels clearly identify potential cancer risks of products based on the “best available science.”

The proposed legislation, H.R. 6022 and S. 3019, would require labeling warnings that are supported by science that is based upon objective scientific practices, which includes findings and data that are reliable and peer reviewed when possible. According to Rep. Adam Kinzinger (R-Ill.), the proposed federal legislation is intended to counter state laws that may cause some products to be “incorrectly labeled with warnings about harms that do not exist.”

To be sure, the fight over coffee and the scope of Prop 65 will not end soon. Public comment on the proposed regulation will be open until August 30, 2018, likely fielding comments for and against the regulation. Should OEHHA’s proposed regulatory change pass, it is also likely that it would be challenged in court. And, given the detractors of Prop 65 both in and outside of California, a challenge to OEHHA’s proposal may be the least concern. Congress rarely agrees on much these days, but they definitely seem jittery over the recent efforts to regulate their morning cup. So, we’ll continue to monitor this potential food fight and keep you posted.  For now, just “sip” back and relax.

[This post was written by Wendel Rosen environmental attorney Wendy Manley.]

Coffee drinkers were pleasantly surprised recently to learn their daily beverage may afford a number of health benefits. The beverage contains antioxidants and nutrients, and may protect against Type 2 diabetes, Parkinson’s, Alzheimer’s and liver cancer. Make that a double latte, please.

            NEWS FLASH:

Warning: coffee contains acrylamide, a chemical known by the State of California to cause cancer.

What just happened?

In short, after eight years of litigation, a California court determined that coffee must bear a warning under the state’s Safe Drinking Water and Toxic Enforcement Act, otherwise known as Proposition 65 or “Prop 65.”

Prop 65 was enacted by voters in 1986 with the objective of eliminating toxic chemicals in consumer products by requiring a warning before exposing a person in California to a chemical listed by the State as causing cancer or reproductive toxicity. If your product contains a listed chemical, it may need a Prop 65 Warning.

While there have been some success stories – trichloroethylene out of correction fluid and lead out of wine bottle caps, jewelry, brass faucets, calcium supplements and ceramic ware, for example – Prop 65 has spawned a cottage industry of citizen enforcers, some of which seek to safeguard human health, others of which are motivated by the reward of penalties and attorney fees.

There are more than 900 chemicals on the Prop 65 List that cause cancer or reproductive toxicity or both. In a few cases, the state has set a “safe harbor” level below which no warning is required. Plaintiffs can initiate an enforcement suit based on a lab test showing the presence of a listed chemical, and the burden falls to the defendant to prove the exposure poses “no significant risk,” which is one excess case of cancer in an exposed population of 100,000 assuming a 70 year lifetime of exposure at that level. The risk assessment needed to establish the no significant risk level (NSRL) is complicated, expensive, and vulnerable to attack in a courtroom. Consequently, the vast majority of cases are settled regardless of the merits of the claim.

Acrylamide was added to the Proposition 65 list in 1990, but not discovered in food until 2002. Since that time, more than 650 Prop 65 claims have been brought for failure to warn about acrylamide in a wide range of food products, including french fries, potato chips, sweet potato chips, vegetable chips, hash browns, bread, bagels, English muffins, breakfast cereals, granola bars, animal crackers, ginger snap cookies, molasses, toasted almonds, black olives, and coffee.

A listed chemical is often times present as an ingredient or contaminant. In many cases, such as lead or cadmium in chocolate or seaweed, it is naturally occurring, and exempt from the Prop 65 warning. Acrylamide is unusual in that it is neither added to coffee nor does it occur naturally – it is created during roasting. Cooking at high temperatures, including frying, roasting and baking, transforms sugars and the amino acid asparagine into acrylamide through the Maillard reaction. Consequently, acrylamide is unavoidable in conventional coffee roasting techniques.

Back to the coffee case. In Council for Education and Research on Toxics v. Starbucks, defendants first argued and lost several defenses based on the NSRL, First Amendment and preemption by federal law. In the second phase of the trial, which concluded in January 2018, defendants argued a rarely utilized defense involving an Alternative Significant Risk Level (ASRL) based on considerations of public health. The regulations provide that “where chemicals in food are produced by cooking necessary to render food palatable or to avoid microbiological contamination,” considerations of public health allow for an ASRL.

The Coffee defendants’ risk assessment calculated an ASRL of 19 micrograms per day, which was an order of magnitude higher than the State’s established NSRL of 0.2 micrograms per day.

To their disappointment, the coffee producers failed to persuade the judge that the ASRL should apply. The court found their expert’s quantitative risk assessment deficient, analytical chemistry methods unacceptable, evidence of health benefits unpersuasive, and the minimum quantity of acrylamide necessary to render the coffee palatable unsubstantiated, among other things. In their objections to the proposed Order, the defendants took issue with a number of the court’s findings and regulatory interpretations. Although the plaintiff immediately filed a motion for permanent injunction, it is widely expected that some or all of the defendants, which total 91, will appeal.

Just as Yogi Berra famously said, it ain’t over till it’s over. If the case is appealed, it will likely be quite some time before we know whether a Prop 65 warning is required for acrylamide in coffee. If a warning is ultimately required, specific warning language may be developed for coffee. Meanwhile, high doses of acrylamide administered to rodents suggests acrylamide may cause cancer in humans, but questions still remain whether one can even drink enough coffee to raise the risk or whether the health benefits more than offset the potential risks.

Food producers investigating acrylamide in their products need to think more broadly, since furfural alcohol is also a Prop 65 chemical generated from the Malliard reaction during cooking. And the Prop 65 plaintiff’s bar knows about it.

We previously wrote about when the FDA postponed restaurant nutritional labeling requirements at the 11^th 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.

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;
   
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;
3. The following statement in bold print: “GOVERNMENT WARNING: THIS PRODUCT CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF CANNABIS PRODUCTS MAY BE DELAYED UP TO TWO HOURS. CANNABIS USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF CANNABIS PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
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.

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.)

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.