Foods and supplements: Are all health claims real?

A deceptive trend has developed in recent years to promote certain foods and supplements with false health claims. Some brands sold today still market their products using these claims.

Both the FDA and the Federal Trade Commission (FTC) regulate food and dietary supplements, as well as health and nutrition products. These agencies work in tandem to identify unsubstantiated claims involving products or marketing practices that may pose safety concerns. They share access to databases on marketing, and routinely communicate with one another.

Health claims for food or supplement products must be reviewed by the FDA and, if approved, are permitted on the labeling of these products to highlight that a food or ingredient may decrease the risk of a disease, disorder, or health condition. These claims must be backed by scientific evidence.

The Nutrition Labeling and Education Act of 1990 (NLEA) granted the FDA the authority to issue regulations guiding nutritional health claims, which must now be reviewed by the FDA via a petition process. Since then, the FDA has authorized only 12 food-related health claims.

Health claims must list the elements of a product and the disease or condition that these elements may benefit. They are also limited to descriptions regarding potential risk reduction in disease, and are not permitted to claim to diagnosis, cure, or treat disease.

Two types of health claims

The FDA permits products to promote two types of health claims. The first is an “authorized health claim,” which is backed by significant scientific agreement (SSA) among qualified experts. “The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship,” according the FDA.

The other type of FDA-backed health claim is a “qualified health claim.” This claim is backed by some scientific evidence but not to the degree of an authorized health claim. In other words, evidence supporting a qualified health claim fails to rise to the level of SSA. The word choice in these claims must be moderated to reflect this lower level of evidence basis.

Here’s an example of a qualified health claim, according to the FDA: “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”

Examples of unverified health claims

The FTC oversees claims made in the advertising of foods and dietary supplements whereas the FDA is concerned with the labeling of these products. Both the FTC and FDA have taken actions against companies promoting various false health claims. Here are a few examples:

POM Wonderful 100% Pomegranate Juice and POMx supplements. POM has been wrangling with the FTC for the past several years over health claims made in advertising its pomegranate-based products. Specifically, POM claims that its products will prevent or treat heart disease, prostate cancer, and erectile dysfunction. The FTC voiced concerns over the clinical research used to support these claims. POM disagreed with the FTC’s findings that their advertising claims were misleading and took their case all the way to the Supreme Court. In 2016, the Supreme Court refused to hear the case, thus upholding a lower court’s ruling that sided with the FTC.

Nobetes. The makers of Nobetes advertised that this pill treats diabetes, keeps blood sugar levels in check, and obviates the need for insulin, despite no scientific evidence to back these claims. Obviously, these claims are dangerous, and despite an FDA/FTC warning in 2016 to stop its false advertising, the makers of Nobetes persisted in disseminating these misleading claims in advertisements on radio, television, and social media. In 2018, the FTC fined the company $182,000 and proscribed them from continuing to make false advertising claims about their product.

Soy protein. In 2017, the FDA proposed revoking the previously authorized health claim that soy protein intake may protect against coronary heart disease. They reviewed the totality of scientific evidence and determined that their previous assessment of SSA among qualified experts with respect to this health claim was unfounded.

“Natural” claims. The term “natural” is a go-to term in health-advertising claims. The FDA’s policy permits the use of the word only when the product contains no artificial or synthetic substances listed on its label, including color additives and preservatives. More recently, the FDA has stepped up its crack-down on “natural” products and is asking the public what it thinks natural means. This step means that the term’s nutritional definition could widen to mean more than just ingredients and may be expanded to refer to natural methods of food production that don’t involve pesticides, irradiation, or pasteurization.

Weight-loss claims. The FTC has leveled hundreds of cases against a range of products promoting false claims of weight loss, and has issued a list of seven “gut-check” claims to help consumers identify weight-loss assertions that are simply too good to be true:

1. Causes weight loss of ≥ 2 lbs each week for 1 month or more without dieting or exercise
2. Causes substantial weight loss no matter what or how much the consumer eats
3. Causes permanent weight loss even after the consumer stops using the product
4. Blocks the absorption of fat or calories to enable consumers to lose substantial weight
5. Safely enables consumers to lose > 3 lbs per week for more than 4 weeks
6. Causes substantial weight loss for all users
7. Causes substantial weight loss by wearing a product on the body or rubbing it into the skin

Of note, the FDA does allow certain health claims to be freely used on products without their explicit permission. For instance, “structure/function claims,” such as “calcium promotes bone health,” are okay in calcium-containing products. Furthermore, “dietary guidance claims” concerning broad groups of foods are okay, too, such as “diets high in fruits and vegetables might decrease the risk of certain types of cancer.”