Author: Arthur Yolles

Some Food Packaging May Soon Contain a Standardized “Healthy” Logo. Why, and What Is “Healthy?”

 For years, the Food and Drug Administration (FDA) has considered revising how it defines the term “healthy.” This April, the FDA is due to publish its updated definition of the term, which would change which foods manufacturers could legally claim are healthy. The definition has not been updated since 1994. That said, what makes this change particularly relevant for manufacturers and consumers is not the change in definition, which is “unlikely to significantly change which foods would be eligible [under] the new [definition].” Rather, it is that FDA is also due to release a new logo that manufacturers could put on food to denote that their product is healthy – basically a healthy stamp, similar to the USDA Organic insignia. (Draft versions of FDA’s “Healthy” symbol can be seen here.).

The FDA has the authority under the Food, Drug and Cosmetic Act (FD&C Act) to promulgate regulations over the types of claims that can be made on food packaging. This includes the power to define terms, such as “healthy.” Several alternatives exist for food manufacturers who cannot meet FDA’s definition of “healthy”, however. FDA very loosely regulates several terms which manufacturers use to convey a sense of health to consumers, such as “natural”. No such logos exist for those terms, though, potentially incentivizing food manufacturers whose products are on the fringe of FDA-defined healthiness to adjust their products’ ingredients.

That said, why put resources into developing an official “healthy” logo? Although it may not be likely to change what every shopper puts in their cart, the initiative is motivated by research suggesting that front-of-pack (FOP) labels, particularly those with an endorsement from some institutional authority (like FDA or USDA), make it easier for consumers to evaluate what they are purchasing. Obviously, part of the reason for this is the time crunch – it is easier to recognize a logo than it is to search the packaging or research a product. However, the location of information on packaging is important as well, as the FDA is also considering FOP nutrition facts, since some consumers are unlikely to look at the back of food packaging. These mini-labels would highlight added sugars, saturated fat and sodium – things consumers might want to see.

What does it mean for a food to be “healthy,” though? When FDA was taking comments over their new proposed rules, many comments philosophically questioned how FDA planned to draw a single line between healthy and unhealthy nutritional contents. While the proposed update to the definition bases itself on the Dietary Guidelines for Americans, 2020-2025 and mainly creates limits based on the percentage of Daily Value for added sugars, saturated fat and sodium, there are reasonable objections to the existence of the definition. If some food product manufacturers are going to be winners under the new “healthy” logo scheme, then other manufacturers that sell food products that could reasonably be a part of a healthy diet may unfairly take a hit. At the same time, a more detailed system of labeling, such as a health rating system or logos identifying specific nutrients, would potentially undermine the simplicity of FOP logos.

FDA Approves Tandem’s Automated Insulin Delivery Technology For Toddlers: Another Step Toward Hybrid Closed Loop Systems in Type 1 Diabetes Management

On November 7, the FDA announced clearance for Tandem’s Control-IQ technology for use by children ages two and older. Control-IQ is a software that inputs glucose readings from Dexcom’s continuous glucose monitor into Tandem’s insulin pumps and, in junction with the user’s insulin-to-carb ratios and daily trends, automatically increases, decreases, and suspends insulin delivery. Previously, the FDA had only cleared children of ages six and older to use Tandem’s Control-IQ.

This advancement represents the latest step toward greater access to hybrid closed loop systems of type 1 diabetes care. Hybrid closed loop systems refer to those like Control-IQ – a device that monitors the user’s blood glucose levels and communicates with an insulin delivery device to adjust insulin dosage autonomously.

Although Control-IQ demonstrates a strong capacity to improve blood glucose control, many diabetes patients lack knowledge and access to the technology. In a recent survey of people with type 1 diabetes by Dexcom, 45% of respondents indicated that they did not know what a hybrid closed loop system was or how it could benefit them.

As the capacity of diabetes care technologies increases – taking the wheel as the decision-maker over the patient – many patients may wonder what would happen if their devices were to make an error and seriously harm them. As of December 2022, the FDA received over 500,000 complaints about the Dexcom G6, Dexcom’s continuous glucose monitoring system (CGM). In late 2019, a woman brought wrongful death action against Dexcom, as her husband’s CGM failed to alert him of his hypoglycemia in time for him to act. This raises concerns for patients with limited capacity to take control and make decisions of their own, including young children and toddlers.

Nonetheless, the FDA’s updated clearance only came after a study released earlier this year showing that hybrid closed loop systems improved blood glucose control for children between the ages of two and five, especially overnight. It also follows recent clearance of Tandem’s Mobi – a smaller, more discrete insulin pump that the user controls from their phone. While Mobi is no more adept at automated insulin delivery than the normal models, intelligence is just one consideration in pursuit of seamlessly integrating diabetes care into the everyday lives of patients. Speaking practically, the aim to eliminate manual blood sugar checks exists because constant self-care is burdensome and exhausting. Likewise, so is wearing equipment all hours of every day. From the perspective of the patient’s daily experience, comfort and algorithmic advancement go hand-in-hand.

FDA clearance is distinct from FDA approval. While approval means that a product or treatment’s benefits outweigh its risks, clearance means that a product or treatment is substantially equivalent to a previously approved version.

That said, even if Tandem’s new products are to earn approval, FDA approval cannot entirely shield a device manufacturer from liability. FDA approval represents a floor for safety standards and is not enough to defeat a claim against a medical device or drug manufacturer on its own. In practical terms, the FDA’s standard gives diabetes patients and their caretakers both reason for ease and concern. On the one hand, one of the major appeals of closed loop technologies is that patients are free to spend less time manually checking their blood sugar and delivering insulin, especially overnight. On the other, ceding control to an algorithm may feel uncomfortable for some patients, especially those that have taken responsibility for their own care for a long time or are otherwise wary of the rapidly advancing technology.