Recent court rulings to provide strategy to overcome FDA ban on advertising health benefits of fruits and vegetables?

FDA — claiming health benefits of natural foods is illegal

According to the FDA, making health claims for natural foods is illegal. Stating that walnuts, cherries, or any other natural food has health benefits is prohibited, and even citing scientific research to that effect does not help. Such claims, the FDA avers, make those foods into illegal drugs. 

This was the topic about which Jonathan Emord, General Counsel for the Alliance for Natural Health (ANH) spoke at the Health Freedom Expo held September 28th in Indianapolis, Indiana. As the ANH reported, Emord gave the keynote address on “FDA Censorship and the Monopoly of Big Pharma and Big Food.” The FDA, he said, prevents individuals from accessing information about natural products and foods, citing "FDA censorship and the anti-competitive protection provided by federal agencies to Big Pharma and Big Food." One of the ways that the FDA does this is by preventing companies selling natural foods from making health claims.

This is an issue the ANH has been battling for some time. 

FDA out of control

Over the years, the FDA has denied companies selling natural foods the right to say what conditions those foods may help alleviate or what health benefits they provide. Two of the most egregious examples Emord offered during his address at the Expo were that of cherry and walnut growers who listed some health benefits on their websites. The FDA ruled that those claims made the foods unapproved drugs.

Walnuts are drugs?

In 2010, as ANH wrote at the time, the FDA sent a warning letter to Diamond Foods stating that the information they had on their website about walnuts' benefits did in fact make the nut into an illegal drug!

FDA has sent a Warning Letter to the president and CEO of Diamond Foods stating that the firm’s packages of shelled walnuts are “in violation of the Federal Food, Drug, and Cosmetic Act.”

ANH referenced research by Bill Faloon, co-founder of the Life Extension Foundation (LEF) [the research is no longer available but similar information can be found on LEF's site here]. Faloon also provided clarity on the FDA's letter, saying the verbiage in the FDA’s Warning Letter to the walnut manufacturer “makes it clear that the FDA does not even consider the underlying science when censoring truthful non-misleading health claims.”

The following is from the FDA’s letter to Diamond Foods quoting the offending statements and the sections of the code the FDA claimed the company violated:

The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":

• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."

• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "

• "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)]. Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application. (Emphases added.)

Cherry growers' scientific claims can land them in jail!

Other warning letters the FDA sent to food companies, Faloon stated, included warning about claims made by makers of pomegranate juice, green tea, and cherries. In the case of the cherry growers, the FDA stated that the science they cited is irrelevant.

‍[T]he cherry growers cited excellent scientific research from places like Harvard indicating that cherries reduce inflammation and pain. The FDA sent an injunction letter threatening the usual legal penalties—including jail—if this truthful dissemination of scientific research did not stop immediately.

New strategy for overcoming FDA restrictions

At the Health Expo, Emord discussed his new strategy for taking on the FDA, hopeful that two recent court rulings will enable the ANH to successfully challenge the agency in court.

The first ruling is from the Loper-Bright case, which, ANH explained, makes it possible to challenge federal agencies' interpretations of ambiguous statutes.

. . . overturned the Chevron deference, a long-standing precedent that gave federal agencies the right to interpret ambiguous statutes. By reducing the authority of agencies like the FDA and FTC, this decision opens the door to legal challenges against their restrictive policies, potentially benefiting access to natural health solutions.

The second one is the Axon Enterprises case, in which the court allowed litigants to challenge the constitutionality of agency actions.

[It]enables constitutional attacks on administrative agencies, allowing litigants to challenge the constitutionality of agency actions directly in federal court. This is a crucial step in protecting health freedom from overreach by unelected bureaucrats.

A consumer rights issue

Health activists say that these developments have a bearing on their right to make informed choices. Whether it’s a simple walnut or a vibrant cherry, being informed about the benefits of what they consume should not turn a food into a drug, they explain, making what started as a business issue into one of consumer rights to health information. As ANH concluded its article on Emord's talk at the Expo:

The path forward will rely on strategic legal actions, public advocacy, and continued efforts to inform individuals of their rights to access truthful, reliable health information.

ANH tweeted the clip below in which Emord talks about the journey to individual freedom without government intrusion: