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Best practices and education for probiotics amid regulatory uncertainty

Posted 15 June 2021 | By Andrea W. Wong, PhD  | PDF Link PDF | ©

Best practices and education for probiotics amid regulatory uncertainty

Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – all with no final guidance or updates from the agency. With the growth of this category and continued regulatory uncertainty, responsible industry has stepped up with best practices and educational resources to ensure stakeholders understand the unique nature of probiotics.
 
Introduction
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.1 These ingredients continue to gain popularity with consumers because of growing product innovation and the developing body of scientific research demonstrating a variety of health benefits. Probiotics are most widely known for their role in maintaining digestive health, but not all probiotics act the same way. Different probiotic species and strains have unique bioactivities and may affect different systems in the body (digestive, immune, cardiovascular, etc.).
 
Given that probiotics are live organisms, they require different labeling practices from other products, and have unique storage and handling requirements. To address these unique needs, the Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA) developed scientifically based best practices for the labeling, storing, and stability testing of dietary supplements containing probiotics.2 These best practices, adopted in 2017, were designed to facilitate transparency and consistency in the probiotic sector.
 
Best practices
The best practices include a recommendation to label probiotic products in colony forming units (CFUs), which are currently the most prevalent scientifically accepted unit of measure for probiotics. However, FDA regulations require dietary ingredients (with the exception of some vitamins) to be labeled by weight (such as in milligrams). Labeling probiotic quantity by weight does not provide information on the number of live microorganisms in the product. In addition, some of these probiotics may die over their shelf life so it is not possible to distinguish the weight of live microorganisms from that of dead microorganisms or from that of the fillers used to standardize the probiotic raw materials.

Following the adoption of industry best practices, IPA submitted a citizen petition to request the FDA amend the regulations for nutritional labeling of dietary supplements3 to require declaration of the quantitative amount of probiotic ingredients in a dietary supplement in CFUs instead of by weight on the product label.4 CRN supported the petition and also requested the agency exercise immediate enforcement discretion on dietary supplements containing probiotics that declare probiotic quantity in CFUs instead of weight on the product label.5
  
In September 2018, the FDA denied the request in the aforementioned petition.6 Instead, the agency issued a draft guidance on quantitative labeling of dietary supplements containing live microbials,7 indicating its intent to exercise enforcement discretion for firms that declare the quantitative amount of live microbial ingredients in the supplement facts label in CFUs in addition to the required metric weight.7 In response, CRN commended the agency’s intent to exercise enforcement discretion when supplement marketers use CFUs when declaring the quantity of live microbials on a supplement facts label, but raised concern with the FDA’s position that supplement labels should also list the quantitative amount of live microbial dietary ingredients by metric weight.8
 
To date, the FDA has not finalized the guidance or responded to stakeholder comments on this issue. The delay has resulted in uncertainty for the dietary supplement industry and confusion among consumers. To provide clarity, responsible industry continues to promote best practices and educate stakeholders. Recently, CRN launched a retailer education campaign, “Probiotics: What’s Inside is Alive,” to help inform retailers and consumers about the intricacies of these living organisms, help retail buyers better curate their offerings, improve retailer handling of probiotics, and inform customers about the benefits of these products.9
 
Education resources
The education initiative reinforces proper probiotic labeling, which comprises 3 components: quantity, viability, and identity. As already noted, the quantitative amount of probiotics in a product should be labeled to reflect live microorganism count, such as CFUs. This gives consumers the most accurate information about the amount of viable microorganisms present in a product. If a label lists probiotic quantity by weight, it would be impossible for consumers to understand how much of the product is actually live microorganisms that confer a benefit. The number of live microorganisms expressed as CFUs cannot be derived from the weight amount as there is no correlation between CFUs and weight.
 
Like many other ingredients, probiotics can naturally lose activity over time. Therefore, the labeled quantity of probiotics should reflect the quantity of live cells at the end of their stated shelf life (e.g., the expiration or “use by” date), not at the date of manufacture. If a probiotic product label includes only the number of organisms at the date of manufacture, consumers will not know whether the probiotic will still be viable in the quantities needed to provide the desired health benefits at the time they take the product.
 
Ensuring proper probiotic identity is also critical for understanding the intended health benefits of different probiotic products. The label should identify the genus, species, and strain for each microorganism in the product. This is important because not all probiotic strains are alike or serve the same function in the human body. While strain attributes and benefits may overlap, one cannot assume that research on one strain of probiotic applies to another strain, even of the same species. Identifying probiotics to the strain level is vital for understanding which health benefits they can offer to consumers.
 
The educational program also provides information on proper storage and handling requirements for probiotics. As living organisms, probiotics are generally sensitive to changes in temperature and humidity, so while some products are shelf-stable at room temperature, others require refrigeration. The probiotic strains in the product; formulation matrix and dosage form; and product packaging, transportation, and storage all affect the extent to which a product is impacted by temperature and humidity. Assets from the education campaign, including a retail buyer’s guide and scientific white paper, provide resources for both retailers and consumers to have the information they need to ensure probiotics remain viable throughout their life cycle. 
 
Conclusion
While federal regulatory action on probiotics remains stalled, consumer interest, product innovation, market growth, and scientific research in this category continue to expand. Given these advancements, it is critical for industry to step up and provide clarity around best practices for probiotics. CRN and responsible industry will continue to promote best practices for probiotics and provide educational resources for retailers, consumers, and other stakeholders to better understand the intricacies of these living organisms.


Abbreviations
CFU, colony forming unit; CRN, Council for Responsible Nutrition; FAO, Food and Agriculture; Organization of the United Nations; FDA, [US] Food and Drug Administration; IPA, International Probiotics Association; WHO, World Health Organization
 
About the author
Andrea W. Wong, PhD, is senior vice president, scientific and regulatory affairs, at the Council for Responsible Nutrition. She leads CRN’s science and regulatory affairs department, responding to emerging scientific and regulatory issues as well as advocating for science-based nutrition. Wong also provides scientific expertise in evaluating research relevant to the benefits and safety of ingredients and dietary supplements, and in support of CRN’s nutrition policy activities. She leads proactive, self-regulatory initiatives, including the development of best practices guidelines for industry on product labeling and formulation. She may be contacted at awong@crnusa.org
 
Citation Wong AW. Best practices and education for probiotics amid regulatory uncertainty. https://www.raps.org/news-and-articles/news-articles/2021/6/best-practices-and-education-for-probiotics-amid-r. Regulatory Focus. Published online 15 June 2021.
 
References
All references accessed on 11 June 2021
  1. World Health Organization and Food and Agriculture Organization of the UN. Probiotics in food: Health and nutritional properties and guidelines for evaluation [FAO Food and Nutrition Paper 85. http://www.fao.org/3/a0512e/a0512e.pdf Published 2006.
  2. Council for Responsible Nutrition. Best practices for probiotics.  https://www.crnusa.org/sites/default/files/Probiotics/CRN-IPA-Best-Practices-Probiotics-revised-11-12-20FINAL.pdf. Update 12 November 2020.
  3. Code of Federal Regulations. Nutritional labeling of dietary supplements [21 CFR 101.36]. https://www.ecfr.gov/cgi-bin/text-idx?node=pt21.2.101&rgn=div5#se21.2.101_136. Current as of 9 June 2021.
  4. International Probiotics Association. Citizen petition from International Probiotics Association filed. https://internationalprobiotics.org/download/citizen_petition_from_international_probiotics_association-filed/. Dated 20 October 2020.
  5. Council for Responsible Nutrition. Docket No. FDA-2016-P-3968; Citizen Petition from International Probiotics Association. https://www.crnusa.org/sites/default/files/pdfs/comments-pdfs/Citizen%20Petition%20from%20IPA%20Support%20Letter_CRN.pdf. Dated 7 March 2017.
  6. Center for Food safety and Applied Nutrition. Regulations.gov website. Citizen petition response to the International Probiotics Association Re probiotic labeling. https://www.regulations.gov/document/FDA-2016-P-3968-0137. Dated 6 September 2018.
  7. Food and Drug Administration. Draft guidance for industry: Policy regarding quantitative labeling of dietary supplements containing live microbials. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-policy-regarding-quantitative-labeling-dietary-supplements-containing-live. Current as of 15 September 2018.
  8. Council for Responsible Nutrition. Policy regarding quantitative labeling of dietary supplements containing live microbials: Draft guidance for industry. 83 Fed. Reg. 45454-45455 (September 7, 2018). Docket No. FDA-2018-D-3464. https://www.crnusa.org/sites/default/files/pdfs/comments-pdfs/CRN_Comments_FDA_DraftGuidance_Probiotic-Labeling_110618.pdf. Dated 6 November 2018.
  9. Council for Responsible Nutrition. Probiotics: What’s inside is alive. https://www.crnusa.org/probiotics. Published 30 March 2021.

 

 

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