In any business, a company must convince the customer that the product is worth the money. However, according to FDA, any business selling alternative supplements is prohibited from making claims that their product has any sort of “curative" values. To consider this a marketing barrier for the industry is an understatement.
Supplement sites aren’t allowed to keep online customer reviews that claim that their product cured someone’s disease. Imagine if Proactive had to delete every review that claimed their face wash actually cured acne. They’d likely have a much harder time convincing customers of its effectiveness.
This is the situation that supplement companies find themselves in. FDA’s guidelines for the supplement industry state that supplements can only take credit for bettering the overall health of an individual: “By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims."
Any labeling outside of these three types is considered a violation. “Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product," according to FDA. They utilize broad phrases such as “accompanying material" to ensure that all aspects of promotion, including videos and reviews, comply with the standards.
“You can never attach a supplement to a health benefit," Reggie Black, chief visionary officer of Better Way Health. “There’s really no good way to do it. Any kind of convincing, persuading word you would use for something else, you can’t apply to supplements."
When posting testimonials to a supplement site, a brand must make sure that all claims, both from itself and from customers, comply to FDA’s guidelines. Six things to keep in mind when obtaining testimonials for supplement product are:
1. Avoid words like “treatment," “cures" and “heals"
2. Avoid any word usage that could lead to consumer misinterpretation
3. Make sure that all health claims can be backed by easily accessible scientific evidence
4. Use terms such as “only," “high" or “low" cautiously, and ensure that they are not misleading (e.g., saying “only 200 mg of sodium" would be misleading if 200 mg is actually a large amount of sodium)
5. Avoid making any guarantees of success or satisfaction from use of the supplement
6. Make sure that all videos and external reviews posted to your site comply to the above guidelines
In essence, all claims must be in compliance with the Dietary Supplement Health and Education Act of 1994 (DHSEA), which was put into place to distinguish the difference between foods and drugs. If a company claims that their supplement has any sort of healing abilities, FDA no longer considers the product a supplement or food, but rather a drug, which has a much stricter approval process. Qualifying as a drug also requires multiple trials and legal hurdles, which can cost millions of dollars, Black said.
“A product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved—and thus illegal—drug," FDA said.
Sellers of supplements like beta-glucan can’t publish peer-reviewed medical journals from immunologists, mentioned Black. “Technically, we’re not even allowed to reference these studies."
In a nutshell, the only thing beta-glucan suppliers are allowed to say is that their product helps maintain and support a healthy immune system, in the same way that calcium suppliers can only claim that their product helps build strong bones.
Even General Mills received FDA’s wrath for its claims that the toasted whole grain oat cereal Cheerios® had “cholesterol-lowering" abilities. FDA found “serious violations" in the campaign due to its implications that the cereal could be used for “the prevention, mitigation, and treatment of disease," specifically cholesterol, thus making the Cheerios® cereal appear as an “unapproved new drug."
The campaign made claims such as, "You can Lower Your Cholesterol 4% in 6 weeks," and “Cheerios is ... clinically proven to lower cholesterol," meaning that Cheerios would have to qualify as a drug versus a delicious morning meal.
Regardless of the fact that cereal is clearly not a drug, due to the way it was advertised, FDA still believed a consumer could be mislead to believe that Cheerios® cereal alone could lower cholesterol.
In order to comply with FDA standards, General Mills changed the cereal’s label to instead read as, “Studies show that three grams of soluble fiber daily from whole grain oat foods, like Cheerios® cereal, in a diet low in saturated fat and cholesterol, may reduce the risk of heart disease."
Another, more recent culprit of FDA standards was Deseo Rebajar Inc., makers of dietary products such as Lipozene and Slim Patch. In this instance, some of the company’s products actually did contain pharmaceutical ingredients that would make it necessary to qualify as a “new drug." However, the company was unaware that the ingredients required such approval until a new clinical investigation was released, thus forcing the brand to correct the labeling violations on the dietary supplements.
Black explained that many supplement websites aren’t even aware of these guidelines or the fact that they may be breaking them. Although it is unlikely that FDA has the resources to warn every supplement company making disease claims, it’s better to play it safe and comply with all standards, regardless of company size. Hiring an experienced lawyer to proofread the website to ensure that all guidelines are properly met is crucial when building and enhancing a supplement business’s website.
“Manufacturers and distributors must make sure that all claims and information on the product label and in other labeling are truthful and not misleading," FDA said.
Ellen Barnes is a journalist, communication specialist, and Atlanta native with more than five years of writing experience, both for magazines and blogs. She has a bachelor’s of arts in journalism and a bachelor’s of science in psychology from the University of Georgia, and has been published in Atlanta Magazine and Music Row Magazine in Nashville. This article was prepared for Better Way Health.
For more information on marketing supplement products ethically and legally, check out INSIDER’s article “The Ethics of Supplement Retail."