CSPI: ‘Lots of firms make immunity type claims, and almost all of them are deceptive’

CSPI litigation director Stephen Gardner was speaking to NutraIngredients-USA after writing a letter to Amway threatening to take legal action unless it revises “unsubstantiated claims” about its Nutrilite liquid dietary supplements.

Nutrilite supplements do not provide same benefits as whole fruits/veg​

According to the CSPI, Amway’s claim that the Nutrilite Immunity twist tube product is an immune system booster that protects your cells is unlawful “because it implies the product will prevent disease. It won’t”.

Meanwhile, Amway’s Nutrilite fruits & vegetables 2GO Twist Tubes falsely claim to deliver the same health benefits as whole fruits or vegetables, argues the CSPI.

“Dietary supplements simply do not provide the same health benefits as a diet rich in whole fruits and vegetables.”

Consumers interpret immunity claims as promise of disease prevention​

Gardner said:“Lots of firms make immunity type claims, and almost all of them are deceptive claims or illegal disease-prevention claims.”

Asked if Amway were to amend the claims to 'supports a healthy immune system' (rather than 'boost' and 'protect' it), he said:“Really, and although it all depends on the exact claim, the problem is the word ‘immunity’ or its cognates.

"Many consumers interpret an immunity claim to be a promise of disease prevention.”

CSPI staff litigator Seema Rattan said: "No one should be deceived into thinking that these pricey little tubes will prevent them from getting sick.”

Immunity claims and hot water​

Several firms in the supplements and food industry have got into hot water recently over immunity claims.

Gerber was recently rapped over the knuckles by ad watchdog the National Advertising Division of the Council of Better Business Bureaus (NAD) for using the phrase ‘natural immune support’ on its babyfoods, while Kellogg invoked the wrath of the FTC for claiming that Rice Krispies ‘help support your child’s immunity’.

Probiotic players including Dannon​, Nestlé ​and Bayer ​have also faced legal challenges over immunity claims in recent years.

Biothera: Immune claims are permitted provided they are backed by credible clinical research​

However, Dr Donald Cox, senior vice president R&D and business development, healthcare, at Biothera - which markets the Wellmune WGP beta glucan for immune health - said the issue was whether firms could support their claims, not immunity claims per se.

"Immune health claims are permitted under DSHEA as long as these are backed by credible clinical research support. Certainly, we cannot speak for the validity of claims made for all immune health ingredients, but do feel that Wellmune WGP is a well-supported ingredient.

"However,I do think that there are some ingredients used in some immune health products that are not science-based, that do not have a defined mechanism of action and that do not have adequate safety data. Some companies use claims that are based on the marketing message to the consumer rather than the need for science.

"Finally, in the past some large consumer goods companies have based immune health claims on the vitamin and mineral content of their products and did not substantiate the claims with clinical research on their specific products."

Embria Health Sciences: Some labels can confuse consumers​

Kevin Boot, regulatory counsel for Embria Health Sciences, which makes the immune health ingredient Epicor - a yeast fermentate - said: “It's unfair to over generalize about immune products, or any condition-specific products for that matter, because there are many supplements backed with good clinical studies and published science."

But he added: "Unfortunately, there are some product labels that do confuse consumers. In the case of immunity products, it may not always be intentional since the immune system is extraordinarily complex and interacts with many other systems in the body. Consumers know that nourishing the immune system requires not just a single type of molecule, but an array of nutrients.”

Endpoints and not just immune markers​

Meanwhile, the FDA had been"pretty consistent"when it came to taking action against unauthorized disease-oriented immune claims, he said.

"It seems the cases currently getting press coverage are focusing on the adequacy of claims substantiation, an area regulated by Federal Trade Commission (FTC). The FTC has said it considers certain immune claims to imply that products can help reduce the incidence and/or duration of cold and flu symptoms. Substantiating such implied claims requires the products to be backed with good clinical studies that look at those specific endpoints and not just immune markers.

"There are ingredients backed by science that meet or exceed FTC expectations. The Agency is putting additional onus on manufacturers of immune-related products to make sure that they include efficacious ingredients. Setting the bar high benefits ingredient companies who invest in gold-standard science, the manufacturers who choose those ingredients and of course, the consumer."

Top-selling supplement brand​

Michigan-based Amway did not respond to a request for comment.

One of the world's largest direct selling businesses, Amway sells products in more than 80 countries via 3 million+ distributors. According to its website, Nutrilite is the world's top selling vitamins and dietary supplements brand.

The CSPI is a not-for-profit consumer advocacy group based in Washington, DC.