The Food and Drug Administration has told Unilever Americas that claims for a Lipton green tea product – mostly references to flavonoid studies on Lipton websites – amount to drug claims and must be amended or removed.
‘Lipton Green Tea 100% Natural Naturally Decaffeinated’ was found to be in breach of the Federal Food, Drug, and Cosmetic Act for making unsubstantiated, cholesterol-related disease reduction claims and misleading nutrition content claims.
The FDA said references to flavonoid studies found on two websites - www.lipton.com and www.liptont.com – established that the product was indeed a drug, along with the fact appropriate usage was not provided.
Antioxidant claims were deemed in breach of nutrition claim rules for lack of specificity.
Unilever Americas director of media relations Anita Larsen told NutraIngredients-USA.com the FDA letter, dated August 23 and giving Unilever 15 working days to act, had prompted a “thorough review of the brand’s marketing” but no action had as yet been taken.
“We will evaluate what they have said but one thing is certain – we will be compliant with the law.”
Foods, supplements, drugs
New York-based food and drug attorney Marc Ullman said the ruling highlighted the difference between the manner in which nutrition research was viewed when it was linked to foods like the Lipton green tea, compared to dietary supplements.
“If the product was a dietary supplement, it might be possible to argue that the website in question was ‘third-party literature’ if the cited material was a balanced representation of the science, reproduced in its entirety, and the subject matter was related to the product,” Ullman said.
“Questions would then center around whether there is a rational relationship between the dose of green tea cited in the study and the amount of green tea in the product. However, there is no such thing as ‘third-party literature’ for traditional food. The linking of the product to ‘disease’ claims will necessarily lead FDA to conclude that the product is being marketed as a drug.”
Ullman suggested that a body such as, for example, the Green Tea Institute could disseminate such information without drawing the ire of the FDA as long as there was no obvious link between studies and particular products.
End-products not ingredients
Arizona-based beverage marketing expert, James Tonkin, founder of HealthyBrandBuilders, backed the FDA move as a long-needed crackdown on the abuse of scientific referencing by companies with spurious links to that science.
“If any brand wants to make a claim, under the appropriate ‘food guidelines’ wherein all ingredients are in compliance with FDA laws, GRAS etc., then ‘clinical proof’ must accompany that claim, on the actual ‘finished product(s)’, not the ingredients themselves,” he said.
“Data collected and published about a singular ingredient cannot be assumed to be the same when presented in another form or in association with other ingredients (perhaps under different ambient conditions – like after hot filling/cold filling).”
He said consumers needed to be protected from, “over-reaching and sometimes blatant ‘marketing hyperbole’ on product efficacy”.
One of the Lipton websites made the following references: "[F]our recent studies in people at risk for coronary disease have shown a significant cholesterol lowering effect from tea or tea flavonoids ... One of these studies, on post-menopausal women, found that total cholesterol was lowered by 8% after drinking 8 cups of green tea daily for 12 weeks ...."
For antioxidant content claims, the FDA noted that, for example, to bear the claim ‘high in antioxidant vitamin C,’ a product must contain 20 per cent or more of the recommended dietary intake, and the green tea product did not do this.
It went on to highlight: “The claim ‘packed with FLAVONOID ANTIOXIDANTS’ does not comply with 21 CFR 101.54(g)1) because no RDI has been established for flavonoids,” the FDA wrote.
The FDA also sent a warning letter to the Dr Pepper Snapple Group over its Canada Dry Sparkling Green Tea Ginger Ale for ‘enhanced’ with antioxidants claims.
The FDA said the product should not make such claims because it is classified as a snack food due its carbonated format.