Overseas, the European Food Safety Authority has rejected all probiotic health claims, often citing insufficient evidence as the reason. In the US, the Federal Trade Commission (FTC) has sought legal action against both Dannon (Danone in Australia) and Nestle over misleading claims made about their probiotic products. While not admitting any wrongdoing, Dannon agreed to a US$21 million settlement and softened its claims about two products - DanActive and Activia.
Danone recently launched Activia probiotic yoghurt in Australia, which spruiks “17 published scientific studies on Activia”. A study-summary on the Activia website refers to only 13, four of which weren't carried out on humans. Also beware the asterisked claims on products: if you're buying Activia to "help improve digestive comfort”, the proviso is that you need to eat at least two tubs a day.
Neither FSANZ or the TGA require substantiation of probiotic health claims prior to being sold. Proof of efficacy for complementary medicines are only required if the product is making high-level health claims or is randomly audited. FSANZ is currently working on a new Nutrition, Health and Related Claims Standard; they told CHOICE its completion may be affected by the government response to the independent food labelling review, which is expected in December this year. In CHOICE’s submission to the labelling review, we advocated tighter, parallel restrictions for health claims on foods and complementary medicines and greater penalties for their misuse.
Name that strain
The type of health benefit and amount of probiotics needed to achieve this benefit is strain specific. According to the International Scientific Association for Probiotics and Prebiotics, a probiotic must be defined at strain level, yet in clinical studies, regulatory records and product advertising, this is often not the case. When we hit stores for a product spot check, we found many are marketed and sold at a genus (eg lactobacillus) or species level (lactobacillus casei).
Companies can also create an entirely new name for their probiotics such as the Bifidus ProDigestis in Nestle’s Ski Activ Digestion Yoghurt, or Danone Activa Yoghurt’s Bifidus ActiRegularis complex. These trademarked creations appear aligned with the product’s claimed health benefits while maintaining a “scientific” sound. While consumers commonly self-prescribe probiotics and most products are widely available without health-practitioner advice, product information available to consumers is often lacking. Danone list the scientific name of the strain in their ingredients, but this information is provided only to “health professionals” on the Ski Activ website.
In Australia, probiotic products are considered either functional foods and regulated by Food Standards Australia New Zealand (FSANZ), or complementary medicine and regulated by the Therapeutic Goods Administration (TGA). Under the Food Standards Code, fermented milk beverages and yoghurts that claim to be probiotic must have a minimum of 1 million live bacteria per gram.
While complementary medicines must show the amount of an active ingredient, foods don’t have to disclose the number of probiotic bacteria in a product, which makes it difficult for consumers to make an informed purchase decision. The number of probiotic bacteria should be maintained to the end of a product’s shelf life to be of any health benefit. But stability testing isn’t always undertaken by manufacturers and independent testing has shown some products have far fewer probiotics than they claim.
CHOICE believes that health claims on food or complementary medicines should undergo pre-market assessment by the regulators to prevent manufacturers from making misleading or unsubstantiated claims. All probiotic products should name the probiotic bacteria to strain level and disclose the number of bacteria in the product to help consumers in their purchase decision.