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Special edition: Applying health claims

FTC's two-pronged approach to ensuring accurate marketing

By Lorraine Heller, 09-Apr-2008

Related topics: Health claims, Regulation, Antioxidants, carotenoids, Dairy-based ingredients, Dosage forms, Fibers and carbohydrates, Minerals, Nutritional lipids and oils, Phytochemicals, plant extracts, Probiotics and prebiotics, Proteins, peptides, amino acids, Soy-based ingredients, Vitamins & premixes, Bone & joint health, Cancer risk reduction, Cardiovascular health, Cognitive and mental function, Diabetes, Energy & endurance, Eye health, Gut health, Immune system, Maternal & infant health, Respiratory health, Skin health, Weight management, Women's health

In the third article in a series on health claims, NutraIngredients-USA.com examines what the US Federal Trade Commission (FTC) looks for when it assesses products for accurate marketing.

FTC is a law enforcement agency responsible for ensuring that consumer products are properly marketed. Whereas the US Food and Drug Administration (FDA) regulates product labeling, FTC regulates product advertising.

The two agencies work in close coordination, often with overlapping jurisdiction and joint enforcement.

According to Michelle Rusk, from FTC's division of advertising practices, the agency's main goal is to stop unfair and deceptive practices in commerce.

Unlike FDA, which differentiates between product categories and types of claims, FTC approaches all consumer products in the same way, Rusk told attendees at Expo West in Anaheim, California, last month.

The two basic principles it looks for when assessing product marketing are:

Advertising must be truthful and not misleading

Objective claims must be substantiated before they are made

Ad meaning

"When we look at an advertising case, we look at how claims are being conveyed to the consumer. It is very consumer-focused; we look at what consumers will take away, not what you intend to say," said Rusk.

"You are responsible for claims a reasonable consumer will take from your ad."

When evaluating product advertising, the agency takes the following into consideration:

  • Express and implied claims

  • Net impression

  • Testimonials ("If you can't convey efficacy directly you should be careful about using testimonials")

  • Disclosure of material information ("Mouseprint footnotes are not effective disclosures")

Substantiation

The second part of FTC's analysis involves examining whether claims are sufficiently substantiated.

The agency said it looks for "competent and reliable" scientific evidence; "We'd be looking for well-controlled clinical studies showing a significant effect".

Rusk said FTC is "rigorous but flexible"; "There's no fixed formula as to 'adequate support' because it is so diverse."

She added that the agency looks at all evidence, not one study in isolation.

"We'll look closely at all evidence, and that's something you should be doing too. If there are inconsistencies between the study you cite and other scientific literature then there may be a problem or you may need to understand these and explain them," said Rusk.

"New studies come through all the time. You mustn't latch on to any new study - it is better to wait until there is a solid body of evidence. Also, if a study reveals a negative effect, you need to consider it."

Rusk highlighted four main points that food and supplement companies should keep in mind when considering the substantiation of health claims on their products:

  • Product claims must match the evidence

  • Do not overstate the science or benefit

  • Anecdotes are not evidence

  • You cannot base claims on placebo effect

To view the NutraIngredients-USA.com article on choosing health claims, click here .

To view the article on FDA enforcement action, click here .

Other articles in the series:

Choosing Health Claims

FDA enforcement action on health claims

When FTC gets tough on misleading marketing

Legal advice to avoid FDA/FTC claim clamp-down

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