Regulating Probiotics Use
The quest to health and wellness has become a universal mantra. The use of probiotics in food, food supplement, drugs, medicine, and even in cosmetics, have been immensely pervasive. In response to this mantra, more and more manufacturers of food, drugs, and even cosmetics, are integrating prebiotics and probiotics in their products, with wide commercial availability in almost all parts of the world.
The Food and Drug Administration of the Philippines has, as early as 2004, responded to this. The Philippine FDA issued Bureau Circular No. 16, series of 2004, otherwise known as the Guidelines on Probiotics. The FDA Guidelines regulate and govern the use of probiotics in both food and food products.
FDA Pre-Approved Probiotic Strains
The FDA Guidelines enumerated certain approved bacterial strains that may be used as probiotics:
- Nonpathogenic strains of Streptococcus
- Sacchromyces boulardi
- Bacillus causii
The FDA Guidelines did not make any distinction as to where these bacterial strains may be added. What is clear however, is that if the bacterial strain used as a probiotic in a food or food product is among those enumerated above, there is no more need to present additional documents to prove its safe use as a food additive or food supplement.
However, if the bacterial strain is not among those approved by the FDA, the applicant would still need to: (1) demonstrate evidence of safe use as food supplement, and (2) conduct an analysis on the bacterial species found in formulation.
FDA Regulations for New Probiotic Strains
For bacterial strains which are not enumerated above, the FDA requires:
- Safety data to be submitted to prove that there will be no adverse effects to the consumer. This safety data refers to any third-party analysis to prove that the ingredients would be safe for consumer use. This includes, among others, credible full-length scientific journal articles, and may even include website articles so long as it is from a credible source, proving that the ingredients are safe;
- Certificate of Analysis for physio-chemical and microbiological parameters;
- Declaration of minimum numbers of viable bacteria at the end of shelf life; and
- The label to include the genus, species, and strain designation; the minimum numbers of viable bacteria at the end of shelf life; the proper storage conditions; and corporate contact details for consumer information.
In addition, if the bacterial strain to be used as a probiotic is not among those enumerated above, FDA further requires proof of the following:
- Its beneficial effect on the host organism
- It should be able to survive in the digestive tract
- It should adhere to the mucosal epithelial cells
- It should exhibit enhancement and protection of the intestinal ecology
- It should remain viable during periods of storage and use.
- It should be demonstrated as safe.
Provide Evidence of Safety of Probiotic
For the demonstration of the safety of a Probiotic, the following documents should also be submitted:
- Determination of antibiotic resistance patterns
- Assessment of certain metabolic activities (e.g., D-lactate production, bile salt deconjugation)
- Assessment of side-effects during human studies
- Epidemiological surveillance of adverse incidents in consumers (post-market)
If the probiotic strain under evaluation belongs to a species that is a known mammalian toxin producer, it must be tested for toxin production. One possible scheme for testing toxin production has been recommended by the EU Scientific Committee on Animal Nutrition (SCAN, 2000). On the other hand, if the strain under evaluation belongs to a species with known hemolytic potential, determination of hemolytic activity is required.
Probiotics Claims and Limitations
The FDA recognizes the following probiotic claims as food supplements and, these may be reflected on the label and can be used for the advertisement of the product:
- Enhancement of intestinal ecology
- Helping improve lactose malabsorption
- Improving digestion
- Aid to the enhancement of natural resistance to intestinal infections
However, if the product has claims of altering disease ,or claims that the same acts as an immunomodulator, the product shall be classified as a drug. Therefore, the therapeutic claim should be based on sound scientific evidence, based on studies on human subjects.
A further limitation or requirement of the FDA is that the approved bacterial strain used as a probiotic should still be viable at the end of the product shelf life.
FDA Regulations for Labelling and other Requirements for Food and Food Supplements with Probiotics
The following should be found in the label of the product using a probiotic:
- Contents, including the genus, species, and strain designation
- Minimum numbers of viable bacteria at the end of shelf life
- Proper storage conditions
- Corporate contact details for consumer information (such as the manufacturer, its address, etc.)
- That there is no approved therapeutic claim
Further, and in addition to the list of requirements laid down under Administrative Order 2014-0029 and FDA Circular 2016-014, the applicant must provide the following:
- Proof of payment or fees as prescribed by current FDA regulations;
- Clear and complete loose labels or artworks, as applicable, of all packaging size, or equivalents as defined by FDA regulations except of bulk raw materials, ingredients and food additives intended for further processing or for distribution to establishments/manufacturers for further processing;
- Pictures of the product in all angles and in different packaging sizes, and from at least two different perspectives allowing visual recognition of a product as the same with the one being registered, as applicable;
- If the product has label claims, documents to substantiate claims, such as technical, nutritional or health studies or reports, market research studies, Certificate of Analysis, quantitative analysis and computations, scientific report or studies published in peer-reviewed scientific journals;
- The mandatory labelling requirements;
- For powdered beverages, it should conform with the microbiological parameters indicated in the Table 13 of the Revised Guidelines for Assessment of Microbiological Quality of Processed Foods (FDA Circular 2013-010).
About Nicolas and De Vega Law Offices
If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, registration of cosmetics, food supplements, licenses to operate or other applications with the Food and Drug Registration, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues, we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines. You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines. You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at [email protected]. Visit our website https://ndvlaw.com.