It’s a New Year, and many Americans are committed to a healthier lifestyle — at least for a couple of months, or weeks. However, it is difficult to communicate to consumers the importance of dietary choices and the impact on their health. Specifically, food companies cannot effectively relay the impact that poor dietary choices have on preventing or managing chronic diseases without running the risk of the U.S. Food and Drug Administration (FDA) branding their products as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FDCA).

This New Year, however, provides an opportunity for the federal government to put health first. With Rober F. Kennedy, Jr. positioned to take the reins at Health and Human Services (HHS), the emphasis on promoting health appears to be at the forefront of the new Trump Administration.

False Choice Between Drugs and Foods

RFK Jr. is a big proponent of health and lifestyle choices. Importantly, he believes that dietary choices are important to the health of all Americans. Thus, there is an opportunity to bury the false dichotomy in our antiquated regulatory system, i.e., there are either drugs or foods (food includes dietary supplements).

It’s absurd that foods that legitimately make disease prevention or management claims are deemed to be unapproved drugs under the FDCA. This false dichotomy has led to an epidemic of chronic diseases associated with poor dietary choices. In fact, 80% of chronic diseases are related to poor dietary choices. Yet, if you sell a food or dietary supplement that can actually prevent or manage that chronic disease you are still not permitted to make that claim unless you embark on a long and expensive new drug approval process.

The antiquated FDCA does not make people healthier. Instead, it has serious ramifications for overall health and wellbeing while increasing our healthcare costs. It is time that we stop denying the truth of lore that “food is medicine” and “an ounce of prevention is worth a pound of cure.” The current FDCA denies this truth and compels FDA to label any food that helps to manage disease as an unapproved new drug.

Time to Reform the Food, Drug and Cosmetic Act

The best way to address this problem, and better manage and prevent dietary related chronic disease, is to reform the FDCA by recognizing that foods can manage certain conditions and the drug pathway is not the only way to promote health, especially health related to preventable diseases.

The most effective mechanism to address the epidemic of chronic disease is through dietary and lifestyle choices, not drugs. Drugs have a place in many cases; but in many others, we are too quick to prescribe a drug than offer effective dietary choices.

To be clear, this is not a failure of FDA but of the FDCA. It is a failure of law and policy that needs correction. Consumers would be better informed by allowing claims for food products that help reduce or manage chronic diseases such as IBS and Type 2 diabetes.

Personal Experience

My own story in this instance is useful to demonstrate how dietary management can reduce or even reverse diabetes. Seven years ago my A1C was at 6.4 (which is marginally diabetic). My physician suggested we use a combination of drug therapy and diet to control it. After discussions, he hesitantly agreed that the initial approach will be through dietary intervention and the use of a continuous glucose monitor (CGM) to track my blood sugar and determine how different foods and dietary supplements impact my levels.

Within one year, my A1C was down to 5.6-5.7 and has stayed within that range. Because of my law practice, I knew which foods are low in carbs and which supplements could help with blood sugar management. I understood that not all sugar alcohols are calorie free. I also understood that just the taste of sweet could cause my brain to signal the release of insulin.

Most individuals don’t grasp this concept, making it difficult to make the correct dietary choices when at the grocery store. For individuals that are borderline diabetic, it is difficult to make the correct food choices by just looking at a Nutrition Facts panel.

Indeed, consumers today believe “added sugars” are bad and that “sugar” by itself is better, which is not necessarily true. Food is more complex than the simple information provided in the Nutrition Facts box. An incomplete picture can lead to bad food choices and negative health outcomes.  

Defining ‘Healthy’

The FDA’s attempt to define “Healthy” is also problematic, because its definition fails to account for the true complexity of food. FDA should have learned its lesson when “low-fat” was promulgated and companies stripped fat from products, replaced it with simple carbs, and diabetes exploded in not only adults but also in children. Nutrition is complex and companies should be allowed to explain the benefits of consuming their products.

In sum, consumers often don’t know whether a particular food product may be helpful in managing IBS, diabetes, prediabetes, or other chronic diseases. Instead, FDA may send a warning letter informing the company its product is an unapproved new drug even though the food is beneficial to managing a diet-related health condition or disease. 

In the end, the FDCA is not designed to promote nutrition as a means of preventing or managing diet-related chronic disease. Rather, it is designed to prescribe drugs (with their potential side effects) even though dietary management may be the better choice. If dietary choice fails, the drugs are available; but it is better to address chronic diseases through nutrition first. Preventing one chronic disease may prevent another one from developing; for example, diabetes increases the risk of cardiovascular disease.

Unfortunately, however, the FDCA is written in a manner that almost guarantees that truthful and non-misleading information regarding appropriate food choices is not permitted, and potentially suppressed out of fear that FDA will consider products unapproved new drugs.

To be clear, I am not stating that claims should be allowed in all cases. Rather, if there is competent and reliable scientific evidence — whether through history of use or clinical studies — that certain food products will help manage or prevent chronic diseases related to dietary choices, these claims should be permitted (without spending millions of dollars to support the claim).

Hopefully the new Administration, with its allies in Congress, will take a serious look at the FDCA and pass laws that truly promote health in the first place.