The probiotic market is growing rapidly, with more manufacturers of foods, supplements and drugs looking to beneficial bugs and the power of manipulating our microbiome as the next frontier for health and wellness.
However, Italian expert Professor Claudio de Simone, retired from the University of L’Aquila, argues that a lack of tight regulations about how manufacturers can formulate and package probiotic products means that consumers with health issues may miss out, while doctors and medical professionals may become less trusting.
de Simone warns that the label term ‘probiotic’ is often misused by being applied to products that do not meet the criteria, while the use of term as an umbrella term has the potential to cause confusion to consumers and healthcare professionals.
“Even though significant progress has been achieved in understanding the possible applications and health benefits of specific probiotic strains, many doctors, scientists, and consumers are still confused by the “probiotic umbrella” concept that is commonly promoted by the probiotic industry,” he suggests.
“The umbrella concept seeks to take advantage of results obtained with a specific probiotic by extending them to others, blurring the specificity of the product, dose, duration of intake, combination of strains, and methods used to manufacture the formulation with which the benefits were obtained.”
‘Relatively unregulated’
de Simone says that because of the ‘relatively unregulated nature’ of this aspect of probiotic market, transferal of claims – from a tested product to one that has material differences in its formulation or manufacturing process – opens the door to many problems and questions.
This is especially true since many properties of probiotic products are strain-specific. As such, both safety and efficacy findings associated to specific formulations ‘should not be generalised to other probiotic products’, he warns.
He added that the current industrial focus on strain genetics ‘is not enough’ to certify the consistency of product over time because the carrier matrix (including proteins, carbohydrates, and lipids) can all have an impact on probiotic efficacy and viability.
“Insufficient attention to the probiotic-matrix relationship will lead to the production of lots which are not consistent with what previously manufactured and clinically tested.”
Trademark issues
de Simone warned that current trademark law means that a trademark owner can commercialise any formulation under the same brand, even if significantly different from the original.
“A probiotic mixture shown in the scientific literature to be effective in the treatment of specific diseases or conditions will be referred to by doctors, experts, and patients solely by its trademarked name, because it is not eligible for a standard generic name as given to pharmaceuticals, and referring to the full list of ingredients is not practical,” he said.
“This can create a unique scenario in which the lack of a generic nomenclature, and the inherent difficulty in mentioning each strain in the formulation, makes the commercial name the only way to recognize a specific formulation for its origin, efficacy and safety.”
From a scientific and ethical point of view, the Italian said safety and efficacy data should only apply to that trademark as long as the composition and manufacturing of the product remains unaltered from the version used in research.
However, he noted that a lack of regulation in the probiotic market means that there is no control over the composition or manufacturing of products marketed under a trademarked brand name, while there is a strong protection by the law of the rights associated to a trademark ownership.
“This offers the possibility that any probiotic, even untested, can be sold under a trademark that was used in the past to refer to a formulation well known for origin, efficacy, and safety,” said de Simone.
“What are the consequences if the owner of the brand no longer has access to the ‘original’ probiotic formulation and does not possess or have access to the know-how? And what will happen if the possessor of the know-how does not have access to the trademark that was previously associated to the ‘original formulation’ and is also prevented from referring to the scientific studies by the owner of the trademark?
“These regulatory deficits may have serious consequences for patients where probiotics are used as part of clinical guideline-recommended management of serious conditions such as inflammatory bowel diseases, and may make doctors liable for prescribing a formulation not previously tested for safety and efficacy.”
Naming conventions
Contrary to the situation with biosimilar biopharmaceutical products – which must undergo pharmacodynamic, pharmacokinetic, safety, and efficacy testing to verify equivalence to the original product – tests of equivalence to the original product are not strictly regulated in the event of any changes made to a probiotic product, including the manufacturing process, noted de Simone.
“From a scientific point of view, there is no doubt that changes to a probiotic product, for example in the manufacturing process of the strains used, require new data to verify its efficacy and safety,” he said.
However, the Italian expert noted that the matter is further complicated by the fact that, unlike drugs, probiotics generally do not have single generic names for their active ingredients – especially in the case of multi-strain formulations.
Indeed, he said the state of affairs for the probiotic market is ‘surprising’ and markedly in contrast to regulations that exist for foods and drinks like such as cheese, wine, or spring water.
“Consumers would be less likely to buy a wine if they learned that it claimed to be from a specific region such as Champagne or Napa Valley, but in actuality was not, as they think that a wine, cheese, or water’s region of origin is fundamental in determining its quality,” he said.
It is therefore of ‘fundamental importance’ that the probiotic product sold under a certain brand name maintains its uniformity during the entire marketing period, argues de Simone – noting that this is especially true if it is used or recommended for populations with compromised medical history, based on previously published data and studies.
He concluded that while there are no regulatory problems for probiotics that are true drugs and therefore governed by ‘well-consolidated regulations’, the same cannot be said for probiotics that, although not classifiable as drugs, have been shown to have benefits for human health in clinical studies and are sometimes used for the dietary management of conditions.
“More strict regulations specifically addressing medically beneficial probiotics that are not classifiable as drugs would be welcome.”
Source: Clinical Gastroenterology and Hepatology
Published online, ahead of print, doi: 10.1016/j.cgh.2018.01.018
“The Unregulated Probiotic Market”
Author: Claudio de Simone