Take Probiotics with Caution as Some Efficacy Unproven 25 Samples Not Clearly Labelled Introduce Regulation to Protect Consumer Health

Many consumers choose to take probiotic dietary supplements to promote intestinal health. There are many types of probiotic products on the market, with some claiming to be tailored for women or children. However, the Food and Drug Administration (FDA) of the United States issued a warning last year that a premature baby who had taken a probiotic formula died of sepsis caused by Bifidobacterium, raising public concern about the safety of taking probiotics. Therefore, although there is currently no legislation or standards in Hong Kong to govern the provision of information pertaining to relevant safety and efficacy of dietary supplements, the Consumer Council conducted a market survey with reference to relevant overseas standards and reviewed 40 probiotic products. The survey found that 2 samples were labelled as containing Enterococcus faecalis, which was not recommended by the Joint FAO/WHO Working Group for use as a probiotic for humans due to the uncertainty in their safety. It was also found that 60% of the samples did not meet the international industry voluntary labelling guidelines, with no clear indication of the genus, species, strain of the bacteria and/or their amount, among which 1 sample provided no information on the probiotics at all, making it hard for consumers to make informed choices. In addition, advertisements for many probiotic products claim efficacy in boosting immunity, improving eczema and allergies, etc., but doctors have pointed out that these claims are not supported by large-scale clinical trials or lack sufficient scientific evidence, thus the efficacy is doubtful. Consumers may not get the anticipated results after taking these products, or worse, their maladies might be prolonged. The Council urges the Government to make reference to the regulatory approach of other markets and set up legislation to regulate dietary supplements including probiotics to protect consumer safety.

The Consumer Council sourced 40 dietary supplements on the market claiming to provide probiotics. Among them, 6 were labelled as suitable for women and 11 for children, while 9 out of the 23 general probiotic samples were labelled as suitable for children under 12 years of age, and 11 were not labelled with the suitable age. The prices of the samples ranged from $99 to $788, or $5.3 to $52.6 for a daily serving, a difference of nearly 9 times.

2 Samples Contained Enterococcus Faecalis

Not Recommended as Probiotics for Human Use

With ageing and changes in health conditions, “good” bacteria in the intestinal tract may gradually decrease in both types and amount, resulting in decline in immunity functions. At the same time, modern dietary habits often do not contain sufficient fruits and vegetables, which impacts the growth or reproduction of “good” bacteria in the intestinal flora. Probiotics are microorganisms beneficial to the human body when ingested, and help maintain the balance of “good”, “bad” and “conditioned” bacteria in the intestinal tract. The name of each type of probiotic shall include its genus, species, and strain, and there are currently 17 medically recognised probiotic genera present in the human body. Most of the samples in this survey claimed to contain Lactobacillus, which can improve digestion and accelerate intestinal peristalsis; and Bifidobacterium, which can produce lactic acid, vitamin B complex, acetic acid, and other beneficial substances. Over 90% of the samples (36 samples) were labelled as containing Lactobacillus, and over 80% (33 samples) were labelled as containing Bifidobacterium.

In addition to Lactobacillus and Bifidobacterium, 5 samples were labelled as containing Streptococcus and 2 samples were labelled as containing Enterococcus faecalis. According to the latest safety assessment by the Joint FAO/WHO Working Group, Enterococcus faecalis and Enterococcus faecium are common probiotics belonging to the Enterococcus genus; yet these two strains of bacteria are relatively unstable, easily contaminated or have the risk of turning into pathogens, and have resistance to the antibiotic vancomycin, it is therefore not recommended to use these 2 strains of bacteria as probiotics for human consumption.

Only 40% Samples Listed Strain According to Guidelines

Most with Incomplete Labelling

According to the industry voluntary labelling guidelines by the International Probiotics Association, products should clearly label the genus, species, and strain of probiotics, as well as their quantities in CFU as the unit. However, only 15 samples clearly labelled all strains of probiotics on the packaging, while 1 was labelled with only the strain number, 3 with only the genus, 20 with only the species, and 1 had no information about relevant probiotics at all but only stated “comprehensive probiotics developed by a local university” in its ingredients list, so consumers are unable to identify which specific probiotics they have consumed. Among the 33 samples labelled with multiple species or strains of bacteria, only 7 clearly labelled the number of species, reflecting unsatisfactory labelling.

Furthermore, 19 samples suggested that consumers could consume different doses of probiotics according to their personal needs or health conditions. However, the amount of probiotics is not always the more the better, as the optimal amount of probiotics may vary depending on the species and health condition to be addressed. As general consumers are not healthcare professionals and are incapable of self-diagnosis, they may consume inappropriate doses of probiotics and increase the risk of side effects, or fail to achieve expected results.

Insufficient Scientific Evidence to Support Some Efficacy Claims

All 40 samples carried health claims, mainly on improving gastrointestinal health, boosting immunity, improving eczema/allergy, and improving the health of women’s intimate areas. According to the global guidelines issued by the World Gastroenterology Organisation, if probiotics are labelled with health benefits that are therapeutic, data from clinical studies on specific strains must be reviewed.

The efficacy of most probiotic products is to improve intestinal health. Some gastroenterologists pointed out that although probiotics can indeed improve the flora of the gastrointestinal tract, since consumers are not healthcare professionals, they are unable to self-determine the causes and treatment options for their different gastrointestinal problems, the consumption of probiotics may adversely affect the condition. Over half of the probiotic samples used words like “supports the immune system” or “improves/boosts immunity” on their packaging. While the gastrointestinal tract is part of the immune system, research at this stage has not yet confirmed how different probiotic strains help regulate the human immune system, and there is no data from large-scale clinical trials that can directly correlate or compare immunity effects among different probiotic strains. Many samples were labelled with “eczema relief” or “improve eczema condition”, yet some large-scale clinical trials have found that there is no significant relief in eczema symptoms between patients taking probiotics and those taking placebos. Since there is not enough medical evidence to prove that probiotics or prebiotics^[1] are effective in treating eczema or other allergic dermatitis, they are not considered an option for proper eczema treatment. Consumers with skin problems should seek medical advice as soon as possible to avoid delayed treatment.

It is worth noting that the European Union requires health claims for dietary supplements to be scrutinised by the European Food Safety Authority (EFSA). However, since 2006 over 300 applications for probiotic health claims have been rejected. The reasons for rejection cited by the EFSA included that current scientific research is yet to be able to correctly identify microorganisms involved in the various effects in the body; some health claims have not been clearly defined; some probiotics are not considered to be beneficial to health; or there is no clinical research data on humans in relation to a particular probiotic. Therefore, EU currently does not allow the use of probiotics and their health claims in the labelling or advertising of any product.

Premature Babies Deceased After Consumption

Parents Should Note Side Effects of Probiotics

20 samples claimed to be tailored or suitable for children. Parents should note that since the absorption and immune functions of the gastrointestinal tract are not yet fully developed in newborn babies, it is recommended to consume only breast milk or infant formula but not any other food (including probiotics). The FDA issued a warning in September last year that a premature infant who consumed a probiotic formula while hospitalised died of sepsis caused by Bifidobacterium. FDA warned that microorganisms in probiotics may pose risks of fatal illnesses such as bacteremia in babies born very prematurely or with very low body weight, and that fatal illnesses may also be caused by bacteria or fungi found in probiotics. Presently, the FDA has not approved any probiotic products as infant medication or biologic.

Probiotics in pills form are subject to different classification in different regions, more commonly as dietary supplements. They are often regulated under legislation for dietary supplements or functional food in different regions and countries such as the Mainland, the United States, Canada, and the European Union. The Council urges the Government to refer to international industry standards or regulations of different jurisdictions and formulate relevant standards or legislation on dietary supplements, ensuring that probiotic products available on the market are safe, with satisfactory ingredients and efficacy, so as to safeguard consumer health.

Different probiotic species can bring different health benefits. Consumers should consult doctors and professionals in choosing the right probiotics according to personal health conditions and requirements, as not everyone needs to take probiotics. When choosing and consuming probiotics, consumers may refer to these tips:

• Beware that probiotics may also have side effects. In case of any health problems or illnesses, consult a doctor first instead of taking probiotics on your own to avoid adversely affecting medical condition;
• First understand the product information before buying probiotics on your own, and choose products that are labelled with more comprehensive information and choose those bacterial species/strains with relatively more international recognition;
• Probiotic products may be affected by heat and humidity, and should not be stored at 30 degrees Celsius or above in high humidity. Keep out of reach of children to minimise the risk of accidental ingestion;
• Probiotics should not be relied upon by itself. Consumers can maintain a healthy gastrointestinal tract and strengthen immunity by consuming enough fruits and vegetables, maintaining a balanced diet, and exercising frequently.