Best practices and education for probiotics amid regulatory uncertainty
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Best practices and education for
probiotics amid regulatory uncertainty
Andrea W. Wong, PhD
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issued its draft guidance for industry on the labeling of probiotic quantity.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
©2021 Regulatory Affairs Professionals Society
June 2021
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
June 2021
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.
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
June 2021and 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_prob
iotics_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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