Nutrasource Blog

Health Claims That Can Get You in Hot Water

Posted by Nutrasource on Wed, May 06, 2015

As competition in the food and health product space grows, companies frequently look to health claims to differentiate their products from those of competitors.  Claims that showcase the health and nutritional benefits of a product, while communicating the brand’s values and positioning to the end consumer, can help boost sales when done effectively.  Health claims appear not just on product labels but in all avenues of product marketing and advertising, including company websites, product pages and social media accounts.

There’s no doubt that health claims can help increase product sales, especially a as consumer demand for healthy products increases and regulations change to allow new approved claims.  However, misrepresenting a health claim, or making a statement that is untruthful or misleading, can lead to harsh penalties from regulators, create a public relations nightmare and possibly cause irreversible damage—in terms of both trust and dollars—to a brand.

What kinds of health claims are allowed?

Various types of health claims are permitted for foods, beverages, dietary supplements and cosmetics.  These include statements about the product or ingredient’s health effects and the nutritional content or benefits of a product.

What you can claim, and how you communicate it, ultimately depends on the regulations in the country in which the product is being sold.  In the U.S. and Canada, health claims for foods and beverages, dietary supplements/natural health products and cosmetics are regulated at the federal level under the Federal Food, Drug, and Cosmetic Act and the Food and Drugs Act, respectively.  Companies must comply with the regulations and requirements in order to make a claim.  Overall, claims must be truthful and not misleading. 

Interpreting the regulations for each product type and each claim statement can be tricky.  There are some common pitfalls companies may run into when making health claims (which are reflected in public FDA warning letters).

Here we describe four health claims that can get you in hot water with regulatory bodies in both Canada and the United States so that you know what to avoid.

Making drug-like claims when your product isn’t a drug

In general, products such as cosmetics, dietary supplements and foods cannot make claims that suggest the product will diagnose, cure, mitigate, treat or prevent disease and/or affect the structure or any function of the human body.  Any product that makes claims such as those mentioned above must be regulated as a drug.

To date, countless products that aren’t drugs have been marketed with therapeutic claims – everything from preventing  cancer, treating asthma, curing the common cold and more.  Even if a product’s claim is backed by supportive clinical research, the drug-like nature of the claim can land a company in hot water.  The reality is that non-drug products bearing drug claims run the risk of class action lawsuits, regulatory penalties and negative press in the public domain.

Representing your product as one type when it is in fact another

One common misstep companies make is marketing a product as something it is not based on the regulatory standards in that jurisdiction.  For instance, a recent FDA warning letter was issued to a beverage company selling a “relaxation beverage” containing melatonin.  Melatonin is an additive that is not permitted in conventional foods and beverages.  Though the product was being represented and marketed as a conventional beverage, the inclusion of melatonin as well as the descriptor “dietary supplement” on the product label was considered to be misbranding by the FDA. 

Putting nutrient content claims on children’s products

In Canada and the U.S., products that are intended for use by children under 2 years of age cannot make nutrient content claims.  This is due to the fact that appropriate dietary levels have not been established for children in this age range.

For example, product claims such as, “no added refined sugar," "plus vitamins and minerals," and “plus calcium” are prohibited for products intended for this age group.  It should be noted that this applies not just to product labelling but also to any marketing statements on websites, in social media and through other traditional advertising avenues such as print and television ads.

Making a permitted claim when your product doesn’t meet the criteria for that claim

Certain types of claims have been authorized for use in Canada and the U.S. provided that the product fulfills the regulatory requirements for that claim.  For example, in the U.S., categories of permitted claims for foods include nutrient content claims, health claims, qualified health claims and structure-function claims.

Often products will bear one of these types of claims but fail to fulfill all the requirements in order to make the claim.  Case in point: the FDA issued a warning letter to KIND, a brand of snack bars, for mislabelling at least four of its bars as “healthy,” when in fact the bars exceeded the FDA’s definition of healthy fat limits.

Product claims can be tricky business, so it is critical that companies read and thoroughly understand the regulations to ensure products are compliant (view these regulations here and here).  Failure to do so could have your brand facing scrutiny from regulatory bodies.

The bottom line: don’t put your brand at risk with unsubstantiated or non-compliant health claims.

Need guidance on health claims strategy and compliance? Contact our team today.

Topics: Claims, Regulatory