Special edition: Probiotic regulations and claims

IPA event examines probiotic health claims in the US

By Lorraine Heller

- Last updated on GMT

Related tags: Health claims, Nutrition

A recent conference on probiotics provided an overview of the global regulatory status of the bacteria, as well as the health claims that can be associated with these on different markets. In the first article in a series, NutraIngredients-USA.com examines the state of affairs in the United States.

The International Probiotics Association (IPA) World Congress, which took place earlier this month in Los Angeles, California, was the first global probiotics event to bring together industry, academia and health care representatives under one roof for an in-depth examination of probiotic organisms. One of the four main topics to be examined was the regulation and health claims of probiotics in markets including the US, Canada, Australia, New Zealand, Europe, Asia and the Middle East. The market for probiotics, or 'healthy' bacteria, continues to grow as awareness of their health benefits increases, together with their scientific backing. Some of the benefits of probiotics include immune stimulation, enhancement of bowel mobility, reduction of inflammatory or allergic reactions. "The question that arises from a regulatory perspective is what label claims can be made for probiotic products to convey to the consumer a health benefit​," said Dr Claire Kruger from the scientific research firm Spherix. "The question that arises from a scientific perspective is how to test, evaluate and document the basis for the proposed claim,"​ she told attendees during her presentation on probiotics regulation and health claims in the US, Canada, Australia and New Zealand. United States​ In the US, claims describing beneficial effects can be made as structure/function claims, qualified health claims or significant scientific agreement claims. "Each of these routes has its own burden of necessary scientific evidence and consequent language although there is no pre-approved list of available claims. The wording of the claim is dependent upon the type of claim and the strength and nature of the scientific support,"​ said Dr Kruger. Probiotics in the US could be potentially regulated as dietary supplements, GRAS (generally recognized as safe) ingredients, food additives, or drugs, depending how the product is positioned. Whereas products marketed as drugs would fall under the separate regulatory realm of drug claims, those marketed as dietary supplements, or foods could qualify for nutrition claims, health claims or structure/function claims. For a break-down of the different types of health claims in the US, see the NutraIngredients-USA.com article on 'Choosing health claims', available here​. Health claims​ Currently, there are no approved health claims for probiotics. In order to make a qualified health claim petition, it is necessary to conduct an evaluation of the relationship between substance and disease, together with a summary of the scientific data. A proposed model for the health claims and the scientific data supporting the claims must then be submitted in a dossier to the US Food and Drug Administration (FDA), said Dr Kruger. Information on adverse effects must also be included. Structure/function claims​ Structure/function claims, which describe the role of a nutrient or ingredient intended to affect normal structure or functions of the human body, do not require pre-market approval from FDA. However, the "burden of proof"​ rests with manufacturers, who must have appropriate scientific substantiation to use these claims, said Dr Kruger. Substantiation requires critical analysis and documentation of the scientific studies that describe:

  • The role of a nutrient or dietary ingredient intended to affect normal structure or function in humans;
  • Characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function;
  • General well-being from consumption of a nutrient or dietary ingredient;
  • A benefit related to a nutrient deficiency as long as the statement also tells how widespread such a disease is in the U.S.

Examples of structure/function claims that could be used on probiotic products include:

  • Supports immune function
  • Supports healthy intestinal balance
  • Promotes immune function and overall health
  • When taken daily, helps fortify your body's natural defenses and helps keep your body at its best
  • Clinically proven at major US and European institutions to maintain a healthy intestinal tract and strengthen the body's natural defenses

Dangers​ In January this year, a class action was filed against Dannon, accusing it of using fraudulent health claims to sell some of its Activia and DanActive branded yogurts. The lawsuit alleges that Dannon's own studies failed to support its advertised claims that its products were 'clinically' and 'scientifically' 'proven' to have health benefits other yogurts did not. The class action accuses Dannon of charging a premium of about 30 per cent on the Activia yogurt.

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