Responsibility in Establishing and Substantiating Expiration Dating

August 28, 2018

Continuing our plan to detail the regulatory and fundamental quality responsibilities that all brand manufacturers (especially online-only brands) need to embrace, this piece offers a short discussion about another responsibility/accountability gap that often exists in the industry with the use of expiration or shelf-life determinations.


Expiration dating is not required as part of the Food and Drug Administration’s final rule of Current Good Manufacturing Process (“cGMP”). The cGMP Code of Federal Regulations (“CFR”) 21CFR Part 111 (72FR 34572 at 34856) definitively states that a shelf life or expiration date is not required, but if the company decides to use an expiration date, it must be supported by substantiating data.

That’s only part of the issue though. Companies could, in theory avoid expiration dating and the entire hassle of measuring product stability over time. However, many retailers do require an expiration date as a term of sale. Some brands still elect to not place an expiration date on their products and some others place a manufacture date on the product instead of an expiration date. Consumers also expect to see an expiration date so one can question the logic from a business perspective of companies who dodge this issue.


Expiration dating is a “mostly required” data point for sale of dietary supplements. Because the FDA does not specifically have a requirement for shelf life or expiration dating, many variations of the data are provided in the marketplace. Expiration dates are also not clearly definable at the onset of a product introduction. The benchmark for shelf life is often a “reasonable expectation” as provided by substantiation of information. This vague language can easily, but not rightfully, be altered to fit the wishes of the seller.


The FDA is clear in stating that if an expiration date, or anything similar, is used to sell a product, the date must be substantiated with documentation. The Federal Register document 34855 states the FDA declines to require expiration dating because it is known that accurate and definable analytical testing methods are often not agreed upon.  The document describes a lack of sufficient scientific information to determine the biological activity of certain dietary ingredients used in dietary supplements. The FDA concluded its comments by stating:

“Because the final rule does not require that you establish an expiration date, we decline to offer guidance on the type of data that are acceptable to support an expiration date, other than to repeat that any expiration date that you place on a product label should be supported by data.”

The required substantiation used by many sellers has ranged from accelerated stability studies on product not released to the market to expectations established through analysis of single ingredient(s) used to manufacture the product. Many FDA warning letters have addressed this issue, but no warning letter has clearly defined what expectation for substantiation is required to meet the FDA standard. Furthermore, most FDA warning letters separate any discussion regarding expiration dates as “comments” outside of the general information of the letter.

Stability testing is an acceptable method of substantiation, but no frequency of testing is mandated. A skip lot method of testing at manufacture date, half-life and full-life is a popular method of substantiation for expiration dates. Fundamentally, the substantiation must be a part of a documented SOP which can be referenced upon request. Another factor for consideration when substantiating an expiration date is the obligation that the company has an make the rationale for determination of expiration date available should it be requested.


While the FDA has not made it clear that a specific requirement is set for expiration dates or shelf life determination, the requirement of the marketplace for this information places the responsibility for accurate information on the brand owner.


VitaCare Pharma LLC 3/7/16 Warning Letter


  • Your firm includes expiration dates on the labels for your dietary supplement products. For example, the labels on your dietary supplements: Monster Xplosion capsules and HerDiet Pink capsules have a 3 year shelf life. Similarly, the label on your dietary supplement Stimuloid US Capsules has a 2 year shelf life.

 Any expiration date and storage conditions you place on a product label should be supported by data that demonstrates the product’s shelf life under the recommended storage conditions [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. Please note that the term “expiration date” includes shelf life dating as well as ‘‘best if used by’’ dating [See 72 Fed. Reg. 34912, 34856 (Jun. 25, 2007)].

We note that your written response provided a blank template that you provide to your clients that ask them to verify the shelf life dating; however, no supportive documents were provided to explain the justification for the expiration date.

There are a number of Warning Letters that provide this type of response from the FDA. The summary and consistency of the wording in each of these letters is found in the sentence:

Any expiration date and storage conditions you place on a product label should be supported by data that demonstrates the product’s shelf life under the recommended storage conditions.

What you can do:

It is prudent business practice to include the expiration date on your product labels. To help ensure those dates are substantiated, we recommend the following:

  • Ask your suppliers about known ingredient deterioration
  • Perform stability studies on finished products
  • Test and evaluate retained inventory in a pre-determined and documented manner

Unlock the Power of Transparency: Schedule a Meeting Now

Ready to Illuminate Your Path?
Partner with Trust Transparency Today.

Get inTouch

Lori Diez

Lori Diez combines compassion and excellence to lead organizations to their next level. A small-town Texas childhood taught her the value of hard work and relationships, which she uses to foster teamwork that brings results that have transformed cultures and programs to their highest potential. Her successful career in pharmaceutical and nutraceutical sales leadership and event hosting has prepared her to deliver results as the COO of TrustTransparency, where she uses her industry knowledge to ensure that the company’s operations run smoothly as they support nutraceutical companies in their mission to help others. Lori’s passion for charity reflects her belief that individuals working together can change the world, no matter how small their contribution to the effort. This year, she looks forward to continuing over a decade of service at the Houston Livestock Show And Rodeo, where she will be the Chairman of the Livestock Committee.

Conference Handouts

Conference Handouts

CoQ10 Statin Associated Myaglia Meta Study Barry Tan 0618 Case Study

CoQ10 Statin Associated Myaglia Meta Study Barry Tan 0618 (1)

Statin Q10 Effect Case Study

Statin Q10 Effect Case Study

Schedule Consultation with Trust Transparency

Glynnda Steinford

Glynnda Steinford, Trust Transparency Consulting’s Director of Customer Relations, brings over four decades of healthcare experience to her vital role in client engagement and relationship building. Her diverse background spans from administering medical groups to impactful stints in pharmaceutical and nutraceutical sales, all underlined by her degree in Healthcare Administration.

At the heart of Glynnda’s work is her talent for nurturing long-term connections, a skill she leverages to enhance client experiences and partnerships within the consultancy. Beyond her professional commitments, she enjoys life’s simple pleasures, whether it’s her love for cats and cooking or her ventures into golf, always prioritizing cherished moments with family and friends. Her personal interests echo the dedication and warmth she extends in her professional network, making her an invaluable asset to the team.

Caiti Dowden

Caiti Dowden stands as a crucial pillar at Trust Transparency Consulting, bringing invaluable insight and expertise to her role as Senior Executive Assistant’ since her start in 2018. With an academic background from Sam Houston University and a career shift from education to the nutraceutical sphere in 2010, Caiti has cultivated a sharp acumen for dissecting industry trends and bolstering strategic decision-making.

Her transition from Data Analyst reflects her growth and deep understanding of the business landscape. Caiti’s commitment goes beyond professional excellence; she thrives on balance, drawing from her rich life outside of work to enhance her organizational contributions. Whether it’s family time, volunteering, or rooting for Houston’s sports teams, she believes in embracing experiences to fuel her professional creativity and insight.

In her current role, Caiti’s dedication to dynamic business analysis and operational support proves her to be an irreplaceable asset to our team, embodying the synergy of personal enrichment and professional success.

Pam Hilpert

Pam Hilpert, Chief of Staff at Trust Transparency Consulting, has been instrumental in the firm since its inception, leveraging her 17 years of accounting experience, including a significant tenure in the nutrition sector. Her collaboration with Scott Steinford spans various successful ventures, emphasizing her integral role in the company’s financial and strategic initiatives.

An alumnus of Sam Houston State University, Pam holds degrees in both Business Administration and Accounting, as well as an MBA, adding academic heft to her practical industry insights. Beyond her professional prowess, Pam is passionate about family, enjoys live music, delves into quilting, and volunteers at her church, reflecting her well-rounded life.

Her multifaceted expertise and longstanding dedication make Pam a cornerstone of Trust Transparency Consulting’s operational strength and team unity.

Scott Steinford

Scott Steinford, a trailblazer in strategic leadership, boasts a certified M&A background, having navigated companies from their genesis to industry prominence. His brainchild, Trust Transparency Consulting, born in 2007, stands as a testament to his dedication to ethical business practices and strategic foresight, offering industry stakeholders invaluable guidance.

Beyond founding and steering companies, Scott has enriched the business landscape with his insightful keynotes and prolific written contributions, emphasizing his commitment to elevating industry standards. His executive tenure shines in roles as CEO or President of for-profits like ZMC-USA and Doctor’s Best, extending to significant contributions in non-profit sectors.

Notably, Scott’s influence is a driving force in the CoQ10 market, where his leadership has significantly bolstered the ingredient’s global presence. His roles in various capacities, including as a New Hope Ambassador, keep the community informed, providing in-depth industry reports and insights.

An active advocate within professional associations and an Editorial Advisor for leading industry publications, Scott’s expertise is both recognized and sought after. With academic roots in Pre-Law and a Master’s in Law, his journey transcends textbooks, embodying real-world business acumen and transformative leadership.

Scott Steinford merges visionary entrepreneurship with principled leadership, creating a legacy of innovation, growth, and unwavering commitment to industry excellence.