F&S: Food-drug borderline – approach with caution

Overstepping claim boundaries between functional foods and medical drugs muddies the water, introducing market and consumer confusion.

With an increased focus on preventative healthcare and consumers more actively managing their personal health, they become increasingly interested in products carrying health claims. Consequently, it is essential to ensure they do not misunderstand what they consume.

The main selling point of functional foods is that they could help to prevent future clinical health conditions, which is particularly relevant to younger consumers looking for a better quality of life.

The distinction between foods and drugs is that foods cannot claims to treat or prevent a disease. So, for example, a person may choose to prevent cholesterol build-up by consuming foods that claim to help reduce cholesterol, but would require a medical diagnosis to be treated with statin drugs.

In future, the interest in nutritional profiling by regulators and industry will continue to encourage healthy food product reformulations. However, responsible marketers also need to educate consumers with clear, straightforward messages, supporting them to make good choices.

As market launches increase, failure in communication could mean that many functional products are unable to get off the ground.

Responsible product marketing​

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In the ongoing recession, consumers may prefer to consume functional foods or dietary supplements rather than seek expensive medical help or over-the-counter (OTC) products if they are not clinically diagnosed. Self-diagnosis relies on being in command of the facts, so the onus is squarely placed on companies to ensure responsible product marketing.

For example, a product stating that the consumption of a certain amount of an active ingredient over a period of time produces a specific effect will give the impression that clinical trials have confirmed this.

The type of claim used on food products is what decides which category these fall into. Product labeling or marketing can tip the balance scales in favor of a food or supplement being perceived as a drug.

In the US, foods can use one of three types of health claims: Authorized health claims, qualified health claims or structure/function claims.

Err towards caution​

Erroneous marketing claims carry heavy penalties in fines and loss of revenue. Over the past year alone there has been a string of companies called up by the US Food and Drug Administration (FDA) or the Federal Trade Commission (FTC) for making false or misleading health claims on their products – some of which classify them as unapproved drugs.

Just last week, AirShield dietary supplements from CVS Pharmacy were found to carry unsubstantiated claims of immunity enhancement and cold prevention. In May 2009, General Mills was told to change the marketing for its Cheerios cereal as the cholesterol-lowering claims it made implied the product was intended to treat or prevent a disease, thereby classifying it as an unapproved drug.

Companies must err towards caution in marketing and positioning. Manufacturers opting to truthfully tell what a functional food product delivers could save millions of dollars, time and bad publicity in setting the story straight.

To read the Frost & Sullivan article on the industry in Europe, click here​.​
For more articles in this series, click here​ .​​