FDA

Zoinks! Can the FTC Unmask Advertisements Disguised by Social Media Influencers?

Jennifer Satterfield, MJLST Staffer

Social media sites like Instagram and YouTube are filled with people known as “influencers.” Influencers are people with a following on social media that use their online fame to promote products and services of a brand. But, with all that power comes great responsibility, and influencers, as a whole, are not being responsible. One huge example of irresponsible influencer activity is the epic failure and fraudulent music festival known as Fyre Festival. Although Fyre Festival promised a luxury, VIP experience on a remote Bahamian island, it was a true nightmare where “attendees were stranded with half-built huts to sleep in and cold cheese sandwiches to eat.” The most prominent legal action was against Fyre’s founders and organizers, Billy McFarland and Ja Rule, including a six-year criminal sentence for wire fraud against McFarland. Nonetheless, a class action lawsuit also targeted the influencers. According to the lawsuit, the influencers did not comply with Federal Trade Commission (“FTC”) guidelines and disclose they were being paid to advertise the festival. Instead, “influencers gave the impression that the guest list was full of the Social Elite and other celebrities.” Yet, the blowback against influencers since the Fyre Festival fiasco appears to be minimal.

According to a Mediakix report, “[i]n one year, a top celebrity will post an average of 58 sponsored posts and only 3 may be FTC compliant.” The endorsement guidelines specify that if there is a “material connection” between the influencer and the seller of an advertised product, this connection must be fully disclosed. The FTC even created a nifty guide for influencers to ensure compliance. While disclosure is a small burden and there are several resources informing influencers of their duty to disclose, these guidelines are still largely ignored.

Evens so, the FTC has sent several warning letters to individual influencers over the years, which indicates it is monitoring top influencers’ posts. However, a mere letter is not doing much to stop the ongoing, flippant, and ignorant disregard toward the FTC guidelines. Besides the letters, the FTC rarely takes action against individual influencers. Instead, if the FTC goes after a bad actor, “it’s usually a brand that[] [has] failed to issue firm disclosure guidelines to paid influencers.” Consequently, even though it appears as if the FTC is cracking down on influencers, it is really only going after the companies. Without actual penalties, it is no wonder most influencers are either unaware of the FTC guidelines or continue to blatantly ignore them.

Considering this problem, there is a question of what the FTC can really do about it. One solution is for the FTC to dig in and actually enforce its guidelines against influencers like it did in 2017 with CSGO Lotto and two individual influencers, Trevor Martin and Thomas Cassell. CSGO Lotto was a website in which users could gamble virtual items called “skins” from the game Counter-Strike: Global Offensive. According to the FTC’s complaint, Martin and Thomas endorsed CSGO Lotto but failed to disclose they were both the owners and officers of the company. CSGO Lotto also paid other influencers to promote the website. The complaint notes that numerous YouTube videos by these influencers either failed to include a sponsorship disclosure in the videos or inconspicuously placed such disclosures “below the fold” in the description box. While the CSGO Lotto action was a huge scandal in the video game industry, it was not widely publicized to the general population. Moreover, Martin and Cassell got away with a mere slap on the wrist—“[t]he [FTC] order settling the charges requires Martin and Cassell to clearly and conspicuously disclose any material connections with an endorser or between an endorser and any promoted product or service.” Thus, it was not enough to compel other influencers into compliance. Instead, if the FTC started enforcement actions against big-name influencers, other influencers may also fear retribution and comply.

On the other hand, the FTC could continue its enforcement against the companies themselves, but this time with more teeth. Currently, the FTC is preparing to take further steps to ensure consumer protection in the world of social media influencers. Recently, FTC Commissioner Rohit Chopra acknowledged in a public statement that “it is not clear whether our actions are deterring misconduct in the marketplace, due to the limited sanctions we have pursued.” Although Chopra is not interested in pursuing small influencers, but rather the advertisers that pay them, it is possible that enforcement against the companies will cause influencers to comply as well.

Accordingly, Chopra’s next steps include: (1) “[d]eveloping requirements for technology platforms (e.g. Instagram, YouTube, and TikTok) that facilitate and either directly or indirectly profit from influencer marketing;” (2) “[c]odifying elements of the existing endorsement guides into formal rules so that violators can be liable for civil penalties under Section 5(m)(1)(A) and liable for damages under Section 19; 7;” and (3) “[s]pecifying the requirements that companies must adhere to in their contractual arrangements with influencers, including through sample terms that companies can include in contracts.” By pushing some of the enforcement duties onto social media platforms themselves, the FTC gains more monitoring and enforcement capabilities. Furthermore, codifying the guidelines into formal rules gives the FTC teeth to impose civil penalties and creates tangible consequences for those who previously ignored the guidelines. Finally, by actually requiring companies to adhere to these rules via their contract with influencers, influencers will be compelled to follow the guidelines as well. Therefore, under these next steps, paid advertising disclosures on social media can become commonplace. But only time will really tell if the FTC will achieve these steps.


Will the Vaping Industry Go Up in Smoke?

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.

 


Treating Depression with Ketamine? How The Investment Was Made

Hunter Moss, MJLST Staffer

Depression is a serious mental disorder that afflicts millions of Americans each year. One in three of these individuals struggles to find a treatment method that alleviates their condition, and are aptly said to suffer from treatment-resistant depression. In the most severe cases, treating depression can be a life or death decision—depression is the leading cause of over 41,000 suicides every year. For those dealing with depression, every day is a struggle to persevere and try to regain a sense of normalcy.

A new therapy for treatment-resistant depression was approved by the Food and Drug Administration (FDA) earlier this week, one that could help those that have been unable to find relief elsewhere. The unexpected source of the therapy is esketamine. If the name of this drug sounds familiar, it is because the name is based on, and molecularly similar to, the street drug named ketamine. While originally synthesized in the 1960’s as an anesthetic and first used widely in the Vietnam War, ketamine is now known as a party drug, providing the user with mild hallucinations and a sense of euphoria. Due to its dangerous side-effects and potential for abuse, ketamine was placed on the Schedule III of the United States Controlled Substance Act in August of 1999.

In the early 1990’s, researchers at Yale University first recognized the potential for ketamine to treat the symptoms of depression. Since then, scientists sought to confirm the viability of ketamine as a treatment option for individuals who did not experience relief from other treatment methods. A 2012 study out of Baylor College of Medicine proved just that: 85% of patients with severe depression reported the treatment to be effective. Unlike selective serotonin reuptake inhibitors (SSRIs), which are most commonly prescribed to treat depression and can take weeks to build in a patient’s system before becoming effective, ketamine can provide nearly immediate relief with its full effect being felt in as little as two days.

With the science firmly in place, the next hurdle advocates of ketamine faced was of perception—in the eyes of the FDA and the public alike. Radical clinics began to emerge across the country to provide patients suffering from treatment-resistant depression with a safe, heavily-monitored environment to undergo care. Because ketamine had yet to be recognized as a potential aid for depression by the FDA, clinic physicians would often have to prescribe the drug under the guise of using it as an anesthetic. The “don’t ask, don’t tell” approach to a new treatment for a severe mental disorder created some inevitable quandaries for both doctors and patients, who would be unable to receive insurance coverage for a non-FDA approved treatment program.

While the medical community was well aware of the healing potential of ketamine, pharmaceutical companies were reluctant to make the investment. The average price-tag of a clinical trial for the FDA is $19m. There is certainly a market for the drug with countless Americans suffering from depression. The issue holding pharmaceutical companies back is related to patent law. In order to receive a patent, the proposed invention must be novel—and considering that ketamine has been around for nearly sixty years, that would be an impossible claim to make. Without patent protection, the multi-million dollar investment is bad economics for big pharma, even if the trials could provide relief for millions of Americans.

So why did Janssen Pharmaceuticals, the developer of a treatment method for depression based on ketamine, make the investment and receive FDA approval for its new drug Sprovato? The answer is because Sprovato is esketamine, a sufficiently different molecule from ketamine to be patentable. Certain molecules can be left-handed and have right-handed doppelgangers. While it is beyond the scope of this blog piece (and the ability of its author) to explain the difference between the two, esketamine is the left-handed version of ketamine’s right hand. The deviation between the molecules is a significant enough difference to pass the novelty requirement necessitated by the U.S. Patent and Trademark Office (USPTO). While there is some debate as to whether esketamine is as effective as its counterpart, esketamine passed the FDA’s clinical trials and, for the most part, has been received as a viable alternative to ketamine treatment. This development could help legitimize the countless ketamine clinics that have emerged across the United States over the last few years, yielding a promising new alternative for those struggling with severe depression. At the same time, the story of ketamine raises questions about the roles of several actors in the health care system, specifically pharmaceutical companies, the FDA and the USPTO, in delaying the introduction of life saving medication in order to adhere their respective financial and regulatory requirements.


Health Supplements: The “Wild West” of FDA Regulations

Gabe Branco, MJLST Staffer 

At some point, we all have taken a multivitamin and/or some type of dietary supplement. They are hard to miss in most stores such as Target or Wal-Mart.  The bright colored packaging and unfulfilling promises of “losing weight quickly” without dieting or “building muscle” without working out catches everybody’s attention. Most people assume that these products, ironically labeled “health” or “dietary” supplements, must be safe to ingest due to placing them in the same category as a “drug,” or because they deem the supplement to be “natural.” However, the reason people are mistaken is because the Food and Drug Administration (“FDA”) chooses to differentiate “health” products from “drugs.”

Under the FDA’s current regulatory scheme, “health” supplements are treated more like special foods than drugs. Drugs are considered unsafe until proven safe through clinical trials. These trials must be done on all drugs, even those that are sold without a required prescription. The trials must show that the drug is both safe and effective for the specified use. Once the drug is approved, manufacturers are subject to carefully monitored conditions and packaging requirements. The packaging requirement includes conditions the drug has been proven to treat, known side effects, contraindications, and unsafe interactions with other drugs. After the drug has been manufactured and released to the public for consumption, the FDA follows up on any adverse effects consumers and their doctors report, along with any adverse effects reported by the manufacturer.

“Dietary” supplements, on the other hand, are seen as safe until proven unsafe, a stark contrast to their drug counterpart. The Dietary Supplement Health and Education Act (DSHEA) defines “dietary” supplements as a category of food. As such, “dietary” supplements do not undergo the rigorous pre-manufacturing and post-manufacturing approval and monitoring process that drugs do. DSHEA prohibits supplements from containing anything that may have “a significant or unreasonable risk of illness or injury” when the supplement is used as directed on the label, or with regular use if there are no directions. While the regulation makes clear these supplements should not significantly or unreasonably expose the public to increased risk of harm, DSHEA fails to enforce the regulation with any preventative measures.

DSHEA effectively allows manufacturers to print any statement they wish on “dietary” supplement labels, so long as it is followed by the phrase “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. This practice is troublesome because the statement may suggest or claim outright that the “dietary” supplement treats symptoms or results in an outlandish outcome if taken. Even with the FDA warning, consumers would have little to no reason to assume that supplements placed on shelves everywhere could contain none of the listed ingredients or unknown ingredients that can cause adverse health effects.

The FDA has the authority to stop any production of “dietary” supplement if it is shown there is an increased risk of harm to the public. However, this only occurs after the release of the supplement and subsequent adverse effects impact consumers. Due to the lack of pre-manufacturing testing requirements, many “dietary” supplements contain germs, pesticides, or toxic heavy metals that may adversely impact consumers. In addition, many “dietary” supplements either do not contain what is listed on the label, contain more or less of what is listed on the label, or even contain ingredients not listed on the label. This issue could also stem from parties other than the manufacturers and sellers. Without any regulations pre-manufacturing, many suppliers of ingredients may mix or substitute the ingredients sold to manufacturers with less expensive or tainted filler ingredients.

These issues become problematic when an ingredient the FDA would deem a “drug” finds its way into a “dietary supplement.” Many male enhancers or muscle building “dietary” supplements have been found to contain substances much like Viagra or Cialis, which are regulated as “drugs.” In addition, certain weight loss supplements have been found to contain sibutraimine, which has been banned in the United States. All of these supplements were recalled by the FDA in a reactionary manner. However, in most instances a “dietary” supplement may contain a drug that has little to no known effects. Having little to no known effects makes it more difficult to detect if a “dietary” supplement indeed contains a drug, and if it then must undergo the more rigorous FDA drug requirements. By providing manufacturers and sellers a pathway to produce categorical “drugs” and distribute them to the public without undergoing the rigorous FDA drug testing processes, DSHEA potentially does more deregulation than regulation.

FDA regulations concerning “dietary” supplements should be as stringent as regulations governing drugs. The simplest solution would be to implement the same pre-manufacturing and post-manufacturing procedures that are required of “drug” manufacturers into the “dietary” supplement realm. Doing so would fulfill DSHEA’s requirement that the “dietary” supplements do not cause a significant or unreasonable increase in risk of injury or illness. Additionally, this would allow the FDA to regulate “drugs” to its fullest potential.


FDA’s Nutrition Innovation Strategy: The Right to Remain Silent on Added Sugars

Christina Petsoulis, MJLST Staffer 

As of 2017, obesity rates in the United States reached 38.9%.  It is without a doubt that poor diet is a major contributing factor to obesity prevalence. More specifically, diets consisting of convenience foods containing high amounts of added sugar serve as significant exposures leading to obesity and other comorbidities. A recent study reported that sugar was added to 66% of packaged foods.

While the sugar industry is quick to blame lack of physical activity for America’s obesity rates, research is clear that diets high in refined sugar increase the risk of obesity, cardiovascular disease, diabetes, fatty liver disease, cognitive decline and some cancers.

Though the linkages between food and obesity have been well established in scientific literature for some time, it is not until now that the Food and Drug Administration (FDA) has seriously recognized the importance of diet quality in chronic disease prevention.

On March 29, 2018, FDA commissioner, Dr. Scott Gotlieb, announced the Nutrition Innovation Strategy (NIS). Some of the key elements highlighted in the NIS include: modernizing claims, modernizing ingredient labels, modernizing standards of identity, implementing the nutrition facts label and menu labeling, and reducing sodium. The agency stated that it would be “committed to finding new ways to reduce the burden of chronic disease through improved nutrition.”

Gotlieb’s press release introducing the initiative seems to take a different perspective despite the agency’s intended goal.

In Gotlieb’s statement, he started by explaining the critical importance of a healthy diet in human health. He first introduced the importance of informed consumer choice as it relates to transparent labeling, then dove into the issue of “standards of identity.” Using milk as a key example, he explained that plant-based alternatives to cow’s milk, such as soy and almond-based beverages, labeled as “milk” create major public health concerns, including cases of kwashiorkor (protein deficiency disorder), and rickets (vitamin D deficiency disorder). He then went on to cite a case where a child was diagnosed with rickets as a result of parents assuming a soy-based beverage they fed their child contained the same nutritional qualities as cow’s milk. While the issue of standards of identity is relevant to public health nutrition in the context of protein deficiency and other forms of malnutrition, these issues have little relevance to obesity, or any other chronic disease for that matter.

It is surprising to see that Gotlieb’s press release does not highlight any of the important factors contributing to obesity in light of the initiative’s supposed goals.  The worry, of course, is that the FDA is tip-toeing around food-industry players and, namely, the sugar industry in efforts to avoid conflict. The sugar industry is known for its aggressive efforts to shift blame for obesity on poor diet to lack of physical activity and poor consumer choice. For example, it was recently discovered that the sugar industry paid Harvard scientists to produce favorable results in their nutrition research on sugar’s role in heart disease.

While FDA has addressed the issue of sugar content through “added sugars” labeling requirements finalized in May 2016, little has been done to address sugar content in packaged foods. Serious efforts need to be taken to reduce sugar content in foods on the market to address the obesity epidemic


Health in the Fast Lane: FDA’s Effort to Streamline Digital Health Technology Approval

Alex Eschenroeder, MJLST Staffer

 

The U.S. Food and Drug Administration (FDA) is testing out a fast-track approval program to see if it can accommodate the pace of innovation in the technology industry and encourage more ventures into the digital health technology space. Dr. Scott Gottlieb M.D., Commissioner of the FDA, announced the fast-track pilot program—officially named the “Pre-Cert for Software Pilot Program” (Program)—on July 27, 2017. Last week, the FDA announced the names of the nine companies it selected out of more than 100 applicants to participate in the Program. Companies that made it onto the participant list include tech giants such as Apple and Samsung, as well as Verily Life Sciences—a subsidiary of Alphabet, Inc. The FDA also listed smaller startups, indicating that it intends to learn from entities at various stages of development.

The FDA idea that attracted applicants from across the technology industry to the Program is roughly analogous to the TSA Pre-Check Program. With TSA Pre-Check certification, travelers at airports get exclusive access to less intensive pre-boarding security procedures because they submitted to an official background check (among other requirements) well before their trip. Here, the FDA Program completes extensive vetting of participating technology companies well before they bring a specific digital health technology product to market. As Dr. Gottlieb explained in the July Program announcement, “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the . . . developer, rather than primarily at the product (as we currently do for traditional medical products).” If the FDA determines through its review that a company meets necessary quality standards, it can pre-certify the company. A pre-certified company would then need to submit less information to the FDA “than is currently required before marketing a new digital health tool.” The FDA even proposed the possibility of a pre-certified company skipping pre-market review for certain products, as long as the company immediately started collecting post-market data for FDA to confirm safety and effectiveness.

While “digital health technology” does not have a simple definition, a recently announced Apple initiative illustrates what the term can mean and how the FDA Program could encourage its innovation. Specifically, Apple recently announced plans to undertake a Heart Study in collaboration with Stanford Medicine. Through this study, researchers will use “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation.” Positive research results could encourage Apple, which “wants the Watch to be able to detect common heart conditions such as atrial fibrillation”, to move further into FDA regulated territory. Indeed, Apple has been working with the FDA, aside from the Program, to organize the Heart Study. This is a critical development, as Apple has intentionally limited Watch sensors to “fitness trackers and heart rate monitors” to avoid FDA regulation to date. If Apple receives pre-certification through the Program, it could issue updates to a sophisticated heart monitoring app or issue an entirely different diagnostic app with little or no FDA pre-market review. This dynamic would encourage Apple, and companies like it, to innovate in digital health technology and create increasingly sophisticated tools to protect consumer health.


Snortable Chocolate Fails the Smell Test, But What Exactly Is It?

Tommy Tobin, MJLST Guest Blogger

 

Snorting chocolate does not sound like a good idea. In fact, it sounds downright crazy. Enter the aptly named “Coco Loko.”

As reported by the AP, Coco Loko is a cocktail of cacao powder and common energy-drink ingredients, such as guarana and taurine. Marketed by a company called Legal Lean, the product makes several bold claims and promises, including feelings similar to ecstasy and “a steady rush of euphoric energy that is great for party goers to dance the night away without a crash.” Oddly, that promised effect is juxtaposed with promises of “calm focus” and “natural relaxation.”

Legal Lean advises users to “consume responsibly.” Warnings include the all too familiar boilerplate that product statements have not been evaluated by FDA and that the products are not intended to diagnose or treat any disease. A notable product warning also advises potential customers that Coco Loko is “not recommended for children or pregnant women.” Legal Lean also notes that the product “may impair your ability to drive a car or operate machinery, and may cause health problems.” It is certainly helpful that the company recognizes that snorting a chocolate concoction up one’s nose may result in health issues and is warning potential consumers accordingly. Self magazine summarized the situation succinctly: “If it sounds like a bad idea to snort what basically amounts to glorified hot chocolate mix, you’re right.”

As the Huffington Post recently put it, “snortable chocolate exists now, for some reason.” The mere fact that this product exists raises myriad questions, not least of which is what the product actually is and how it will be regulated.

According to ABC News, FDA is currently weighing whether the product falls within its jurisdiction and is currently “not prepared to issue a determination regarding whether and how this product is subject to FDA jurisdiction at this time. In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use.”

While the intricacies of regulatory classifications are enough to make one crazy, Coco Loko’s regulatory future remains to be seen. As the administrative law bloodhounds at FDA continue their work sniffing out the proper classification for this product, here are some preliminary thoughts.

 

Is Coco Loko a Food?

Strictly speaking, probably not. The statutory definition of food, 21 U.S.C. § 321 (f), is not tremendously helpful here. The statute’s most applicable definition defines “food” as an article used for food or drink for man or other animals. Snorting something through one’s nose is not generally how most people consume their food or drink, especially as the nose is woefully devoid of taste buds.

Legal Lean may argue that an alternative use of the product is as a hot chocolate mix. Presumably, the Coco Loko powder could be used as a drink when dissolved in hot water. Even so, the company markets the product as “infused raw cacao snuff.”

The product’s marketing as “snuff” is highly suggestive that the company does not consider that the product is meant to be food, given that “snuff” is taken through the nose. Put differently, the company may huff and puff that the product is a “food,” but in the end, the stuff is “snuff” by their own admission.

 

Is it a Drug?

Possibly. Coco Loko is likely not a “drug” under 21 U.S.C. § 321 (g). One applicable definition of “drug” includes items “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Such an intention is expressly disclaimed by the makers of Coco Loko.

Another definition of “drug” applies to “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” with a carve-out for foods and dietary supplements. Coco Loko does promise a rush of serotonin and endorphins, as well as “increased overall happiness.”

The structure or function claims made by Coco Loko could make it a “drug” if it is found to be neither a food nor dietary supplement. Put another way, the product appears to be an inhaled stimulant, and regulators could plausibly put it in the category of “drug” given the claims the product is making, in the case that the product does not fit in other categories.

 

Is it a Dietary Supplement?

It depends. Regulators could label Coco Loko as a “dietary supplement” under 21 U.S.C. § 321 (ff). Just as the definition of “food” was quite broad, so too is the statutory definition of “dietary supplements,” which helpfully notes that the term:

 

1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”

 

Given the inclusion of cacao in the product, a colorable claim could be that Coco Loko contains a dietary substance used by man to supplement the diet. That said, is someone actually supplementing their diet by inhaling through their nose? Not being a doctor myself, I can only surmise that the snorted chocolate may have a circuitous path from the nose to one’s stomach—if it ends up there at all.

More on the nose, US News & World Report notes that the product’s label includes B vitamins, ginkgo biloba, blood flow-improving amino acid L-Arginine, as well as energy drink staples guarana and taurine. So, it would seem that Coco Loko would meet the vitamin and amino acid test.

Other aspects of the “dietary supplement” definition in 21 U.S.C. § 321 (ff) include that the item must not represent itself for use as a conventional food or as a sole item of a meal or the diet. “Dietary supplements” must also be labeled as such. If its labeling does not call it a “dietary supplement,” Coco Loko cannot be a “dietary supplement.” According to Ars Technica, Legal Lean is already marketing Coco Loko as a “dietary supplement.”

Incorporated by reference into the § 321 (ff) definition of “dietary supplements” is the requirement that the product be intended for ingestion under 21 U.S.C. § 350 (c)(1)(B). That section requires products be “intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form.” While Coco Loko is a powder, it is unlikely that it is “ingested” in the typical meaning of that term. The statutory provision also provides an alternative definition for items “not intended for ingestion in such a form” that are otherwise “not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.” Both incorporated definitions are predicated on “ingestion,” and Coco Loko’s method of intake is unlikely to fit the plain meaning of “ingestion.”

By analogy, a suppository also bypasses the mouth when they are taken into the body. Even so, suppositories generally go into one end of the alimentary canal—rather than the sinuses or the lungs. Moreover, neither suppositories nor this inhaled chocolate are “ingested.” No less an authority than the Oxford English Dictionary includes a definition of “ingest” that equates ingestion with the introduction of material into the stomach or mouth.

Coco Loko faces an uphill battle getting a “dietary supplement” label given that is probably not “ingested” or intended for ingestion. According to the FDA Law Blog, “FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.” In the end, FDA may find that “ingestion” is distinct from insufflation, or the act of breathing something into the body.

Even if Coco Loko is labeled as a “dietary supplement” and met other aspects of the § 321 (ff) definition, the Secretary of Health and Human Services, pursuant to 21 U.S.C. § 342 (f), could conceivably find that it presents a “significant or unreasonable risk of illness or injury.” While unlikely, the Secretary has the authority to declare a dietary supplement so unsafe that it poses “an imminent hazard to public health or safety.” That said, do not hold your breath for such a declaration—if you do, it’d be harder to inhale the chocolate.

 

Concluding Thoughts

While the safety and propriety of snorting crystalline chocolate powder through one’s nostrils is up for debate, FDA is hard at work sniffing out the proper regulatory classification of Coco Loko.

My preliminary thought is that Coco Loko might be labeled a “dietary supplement,” given its ingredients. On the other hand, its method of delivery—through the nasal passage—is not one typically seen in dietary supplements and is unlikely to fit the “intended for ingestion” prong of the incorporated statutory definition.

Alternatively, FDA may label the product a “drug,” especially with its “structure or function” claims. Either way, if you think I’m going to go snort chocolate anytime soon—you’re loko.


What’s in that? The Dilemma of Artificial Flavor, Natural Flavor & Artificial Color

Zach Berger, MJLST Executive Editor

By law, most food is required to display nutritional information; if a product bears nutrient content or health messages, it must comply with specific requirements. However, as questioned by J.C. Horvath in volume 13 of MJLST, do these requirements really help consumers? For example, how often do you see “contains artificial flavor” or something similar listed on your groceries? The use of the non-descriptive descriptor phrases such as “artificial flavor,” “natural flavor,” and ‘artificial color” are common on food labels, yet do not help the average consumer. These phrases can substitute for over 3900 different food additives. The difference between artificial and natural flavors is much more technical than meaningful as both contain chemicals. The distinction comes from the source of the chemicals. In reality, there is little difference between the two, as both are made in a laboratory by a trained professional, a “flavorist,” who blends appropriate chemicals together in the right proportions.

The Food and Drug Administration (FDA) does regulate these additives, but once a substance is Generally Recognized as Safe (GRAS) it may be added to anything without further testing for any unexpected chemical interactions with other ingredients. Examples of ingredients that fall under GRAS[1] range from beef tallow, lard, and gelatin to ambergris a “waxy substance generated in the digestive system of and regurgitated by sperm whales” and Lcystine, “a dough conditioner often derived from duck feathers or human hair.” Basically, these non-descriptive descriptors don’t tell the consumer anything useful, so companies allowed to use these stand-ins?

The Food industry is generally reluctant about releasing all of its ingredients in order to prevent competitors from easily replicating their product. However, “the information that would actually be useful to consumers tends to be categorical information. Things such as whether or not the product conflicts with dietary restrictions or contains artificial hormones or genetically engineered products. The goal of food labeling is clarity for the consumer and the use of the non-descriptive descriptor phrases are anything but clear; for the average consumer, they may as well not even be on the packaging. To make labeling more informative, Horvath recommended “FDA-mandated universal allergen warnings and front-of-pack labels to better educate consumers.” Whatever the solution is, it is time to end the use of non-descriptive descriptors.

[1] 21 C.F.R. 182.1–.99


What’s Shaking? Sodium Warnings Upheld in NYC Restaurants

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This is the last in guest blogger Tommy Tobin’s latest series on Food and FDA law.  You can find the earlier posts here and here.]

New York’s intermediate appellate court recently upheld a salt shaker. In the February 10, 2017 decision, the court found that New York City could require chain restaurants to mark certain dishes with a “salt shaker” icon, warning consumers that the food contained considerable amounts of salt.

In June 2015, the City issued notice of its intent to require foodservice establishments to warn diners about high salt menu items. After considering over 90 comments and a public hearing, the city adopted its “Sodium Warning” Rule, effective December 1, 2015. In adopting the Rule, the City noted that cardiovascular disease was the leading cause of death in the City and that higher sodium intake was related to increased blood pressure. Further, New York City residents regularly consumed more than the daily recommended amount of sodium and restaurant food was a “primary source” of the salt in New Yorkers’ diets.

The Rule requires chain restaurants—defined as foodservice establishments with 15 or more locations that offered similar menu items—to note food items or meal combinations containing the daily recommended amount of sodium with a specific warning. The warning mandates that a salt shaker icon be placed next to applicable menu items. It also required the following language be displayed at the point of purchase, explaining that the icon “indicates that the sodium (salt) content of this item is higher than the total recommended limit (2300 mg). High sodium intake can increase blood pressure and risk of heart disease and stroke.” The Rule imposes a $200 penalty for non-compliance.

Writing for a unanimous five justice panel, Justice Gesmer ruled against the National Restaurant Association, which had as members more than half the chain restaurants that would be affected by the Rule. The Association challenged the Rule on three grounds, arguing that it violated the separation of powers, was preempted by federal law, and infringed upon its members’ First Amendment rights.

Regarding the separation of powers, the Association argued that City’s health department had exceeded its authority and encroached upon legislative functions in making the Rule. The court was explicit in rejecting the Association’s argument, finding that providing health-related information was the “least intrusive way” to influence citizens’ decision-making. The Rule provided further information to consumers regarding health risks and left it to the diners themselves to decide their dietary choices. The court found that the City has “always regulated” restaurants as necessary to promote public health and did not exceed its authority in adopting this Rule. The court also noted that the same chain restaurants are subject to the City’s calorie content warnings for high-calorie menu items

The Association further argued that the City’s Rule was preempted by federal law, which requires nutrition labeling on grocery store foods. The court rejected this argument as the federal law in question, the Nutritional Labeling and Education Act (NLEA), contained provisions excluding certain warnings and foods from its preemptive effects. Relying on 21 U.S.C. § 343(q) and Second Circuit’s decision in New York State Restaurant Association v. New York City Board of Health, 556 F.3d 114, 124 (2nd Cir. 2009), the court found that the NLEA permits states and localities to establish nutrition labeling for restaurant foods, provided that they are not identical to federal requirements.

The court also examined the appellant’s First Amendment arguments. The Rule would compel commercial speech by placing the salt warnings on menus. Applying the Second Circuit’s New York Restaurant Association, the court examined this compelled commercial speech requirement under a lenient rational basis test. The court found that City’s intended purpose to improve consumer knowledge of potential health risks of salty foods was reasonable. Moreover, the Rule’s applicability only to chain restaurants was not arbitrary or capricious; instead, it was based on health considerations and to facilitate compliance.

The Rule upheld by the court provides advocates new lessons on how to nudge consumers in making point-of-purchase decisions to promote public health. Given the prevalence of cardiovascular disease across the country, additional jurisdictions may consider adopting provisions similar to the “Sodium Warning” Rule. Time will tell how future salt warnings might shake out.

The case is National Restaurant Association v. New York City Department of Health and Mental Hygiene et al., No. 2629, — N.Y.S.3d —- (N.Y. App. Div. Feb. 10, 2017).


As Clear as Milk: Misleading Milk Marketing?

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This is the second in guest blogger Tommy Tobin’s latest series on Food and FDA law.  You can find his earlier post here.]

Milk and cookies are one of the quintessential American comfort food combinations. Even so, considerable controversy has arisen out of products being labeled and sold as “milk.” I guess that’s just the way the cookie crumbles.

“Milk” has a precise regulatory definition under 21 C.F.R. § 131.110. Inter alia, “milk” is “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” Leave it to the C.F.R. to make food sound delicious.

The Eleventh Circuit recently decided that a “skim milk” product could be sold as such. The Circuit’s March 20, 2017 decision in Ocheesee Creamery LLC v. Putnam examined whether a Florida statute barred the business from labeling its product “skim milk” if it did not contain Vitamin A. The court below had upheld that law, and the dairy appealed claiming infringement of its free speech rights. Using dictionary definitions and common sense, the panel ruled that the dairy’s use of the words “skim milk” to describe its skim milk would not mislead consumers.

As consumers walk around the grocery store, they may see other products labeled “milk.” As the AP declared, “fake milk” is one of America’s latest food fights. In addition to milk from cows, consumers may see products labeled as “milk” that are derived from almonds, soy, coconuts, or rice. Would consumers actually get confused between these “milk” products and cow milk? The Northern District of California said no.

In a 2013 decision in Ang v. Whitewave Foods Co., consumers brought suit asserting, inter alia, that products like “soymilk,” “almond milk,” and “coconut milk” represented fraudulent business practices and false advertising as they did not come from cows. The court found the claim utterly ridiculous, finding that the descriptions accurately described the nature of the products. The opinion reasoned that “it is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow. The first words in the products’ names should be obvious enough to even the least discerning of consumers.”

In 2015, the Northern District of California revisited whether “soymilk” would mislead a reasonable consumer.  In Gitson v. Trader Joe’s, the federal court examined whether advertising a product as “soymilk” would violate the Federal Food, Drug and Cosmetic Act. The court first examined whether the use of “soymilk” was false or misleading, finding that the “reasonable consumer (indeed, even the least sophisticated consumer) does not think soymilk comes from a cow.” Second, the court analyzed whether “soymilk” ran afoul of the regulatory definition of “milk” discussed above. The court concluded that Trader Joe’s did not attempt to pass off its soymilk as “milk,” that is the soymilk was not purported to come from a cow.

While many might find the courtroom melee over milk to be melodrama, figuring out what’s in a name is more than making a mountain out of a molehill. It may matter to companies’ bottom lines.

From mayonnaise to margarine, food fights over standards of identity are likely to increase given the rate of innovation in the food industry and its creative marketers, according to the Food+Bev Law Blog. As noted there, “what you call a food clearly influences consumers’ opinions and purchasing decisions.” Time will tell how companies and consumers react to evolving identities and innovation throughout the food industry.