Does your business marketing team know about immunity supplements and FDA compliance? It should, because dietary supplement labels, ads, websites, blogs, and social media must be FDA compliant. Your marketers must know about the FDA, DSHEA legislation, and disease and structure/function claims.

That’s because disease claims on supplement marketing assets send a red flag to the FDA. The Administration will interpret such claims as an attempt to illegally market supplements as drugs. Read about immune support supplement marketing and FDA compliance. And, keep your marketing assets within the law.

DSHEA: Immunity supplements cannot “diagnose, treat, cure or prevent any disease.”
Immunity supplements may not carry disease claims.

Immune Support Supplements May Not Cure

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulate supplement marketing. And, the wrong claims can flag your dietary supplement as a drug. Supplements, according to the Dietary Supplement Health and Education Act (DSHEA) cannot “diagnose, treat, cure or prevent any disease.”

Federal law calls such statements, “disease claims.” And, supplement promotions cannot use disease claims. Drug marketers, on the other hand, can use them.

The Federal Food, Drug, and Cosmetic Act (FDCA), regulates dietary supplements and drugs. However, it legally classifies them as very different entities. Drugs, unlike supplements, in legal terms, are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”

Structure/function claims and immunity supplements.
Immune support supplement businesses can use struture/function claims.

Immunity Supplements and FDA Compliance

Instead of disease claims, immune support supplement businesses can use structure/function claims.  They can also make general well-being and nutrient deficiency disease. Marketers most commonly confuse disease claims and structure/function claims.

“Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.”

FDA – Label Claims for Conventional Foods and Dietary Supplements

Warning letters provide concrete evidence of the FDA application of the concept. They also cite specific unacceptable claims about dietary supplements for immune support. The wrong language can move your content into a dangerous FDA jurisdiction: drug regulation. And, certain claims tell the FDA that you’re marketing your product as a drug.

Examples can help marketers understand how the FDA and FTC interpret these definitions. And, and warning letters provide solid statements from these organizations. Look at some examples of statements that unwittingly marketed supplements as drugs.

Unacceptable Immune Support Supplement Language

The FDA and FTC call out dietary supplement business owners making drug claims. It happens every year. Why?

When supplement marketers make drug claims, they legally classify their products as drugs. The feds have very different rules and regulations for drugs. And, the FTC considers such false claims as misleading advertising.

Why Disease Claims Matter

Disease claims, in the eyes of the FDA, flag your product as a drug. And recall that drugs are “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Legally defined supplements do not “diagnose, treat, cure or prevent any disease.”

No amount of evidence can help you in this case. Businesses simply may not legally market supplements with these terms. Look at this example. A joint FDA/FTC issued warning letter to a natural products producer, in early 2019, cited this as “evidence that these products are intended for use as drugs:”

“The lactoferrin included in the New Ultra Colostrum has been shown in some tests to help the human body’s immune system fight cancer.” – FDA/FTC Warning Letter

The Administration considered this statement unacceptable. In another case, the FDA called out a business owner because claims “misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.” A warning letter specifically listed this claim:

“… helps fight the pathogens we are exposed to on a daily basis … [it] attaches to bacteria, yeast, and viruses, rendering them ineffective and boosting your immune system.” – FDA/FTC Warning Letter

And, citing evidence to support the claim only aggravated the case:

“It’s actually widely acknowledged in both science and the medical industry that ionic silver kills coronaviruses.” – FDA/FTC Warning Letter

Hence, the FDA included it as evidence against the business. Why? The statement legally classifies Vital Silver as a drug, rather than a dietary supplement.

Implied Disease Claims

Even language that implies a cure or treatment can draw a warning letter or litigation. For example, Ebola-C’s owner, legally, “provided evidence” that his product “is intended for use as a drug:”

“Because there is no cure for Ebola it is up to all Americans to defend themselves now! The only defense is to build our immune system to protect them from viruses that attack them.” – FDA/FTC Warning Letter

While not making a direct statement that the supplement cures Ebola, by discussing the lack of a cure in the first sentence, makes the second an implied disease claim.

A different claim set a red flag for the FDA and FTC. It stated that …

“Coronavirus 2019-NCoVat, Treatment Has A Home Remedy. … Protect your immune system try Colloidal Silver 1100 PPM Immune Support” – FDA/FTC Warning Letter

Still another, stated, that its product “seems to boost our immune system and keep infection in general at bay.” These statements illegally reclassify their supplements as drugs. And, that changes the rules for a product without FDA approval.

Getting Help for Immune Support Supplement Claims

Marketers dealing with immunity supplements and FDA compliance can find help on federal websites. A few of them provide a great deal of useful information online. In addition, FDA C&C, our own private business, provides FDA compliance tips. And, an FDA compliance copywriter can save your business time, money, and frustration.

Information from the Federal Government

The FDA site has a number of helpful pages:

In addition, the National Institutes of Health provides original DSHEA text online:

Finally, the FTC also provides information because its truth-in-advertising law regulates all product marketing, including that of dietary supplements. It even has its own advertising guide for businesses in the dietary supplement industry.

Federal Dietary Supplement Assistance

Beyond the federal government, an FDA compliance copywriter can also provide assistance businesses marketing immune support supplements. For example, within this website, a number of posts discuss dietary supplement regulation and compliance:

In addition, a number of legal and marketing services provide information. A search engine can lead you to a number of options.

Hiring an FDA Compliance Copywriter

Effective marketing of immunity supplements and FDA compliance takes a lot of time and money. That’s because research, writing, editing, and re-editing advertising copy frustrates busy business executives and staff.

So, larger businesses with the capital to often outsource such work. It saves cash, takes less of employee time, and avoids the frustration of an overload of duties. By hiring an FDA compliance pro, they cut to the chase and may even spend less than in-house efforts.

There are a number of reasons why hiring a professional writer can save time and money. If you would like to talk with the FDA C&C expert about immunity supplements and FDA compliance, send us a note about your ideas.