Administrative Law

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.

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

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.

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

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