From Challenge to Clarity: Our Journey to Transparency and Scientific Integrity
At Saffron Health Sciences, we are a small, science-driven company with a clear mission:
to create high-purity crocin ingredients and supplements that genuinely support daily vitality and healthy aging.
Our flagship innovation, Crocin Rich®, is the only high-purity natural crocin ingredient on the market and is formally recognized by the FDA as a New Dietary Ingredient (NDI) — an important milestone that reflects our commitment to scientific rigor, quality, and regulatory compliance.
But like many founder-led companies that innovate ahead of the industry, we faced an unexpected challenge in late 2021.
What Happened — And What It Was Not
In 2021, the U.S. FDA issued a Warning Letter (CMS #615429) related not to our product safety, ingredients, manufacturing, labels, or quality — all of which were fully compliant —
but to a technical issue on our educational blog.
Some of our early science articles summarized and referenced published clinical studies that included disease names, which is not allowed when those citations appear on a site that also sells dietary supplements.
Even though the blogs were intended purely for education, including disease terms can be interpreted by the FDA as making prohibited disease/health claims.
To be crystal clear:
❌ This issue was NOT about:
- product safety
- product quality
- product effectiveness
- contamination
- labeling accuracy
- manufacturing standards
✔ It was ONLY about website text in our educational blog.
How We Responded — Fast, Transparent, and Responsible
Despite the timing during the holiday season, we acted immediately:
- Contacted the FDA officer directly
- Removed all non-permitted terminology from our website
- Rewrote blog content to remain educational while compliant
- Linked directly to scientific studies instead of summarizing them
- Ensured all product pages contained only compliant structure-function language
Because we responded quickly, professionally, and transparently, the FDA formally issued a Closeout Letter on January 18, 2022 — just two months after the initial notice.
This officially closed the matter and confirmed that we had fully resolved every concern.
What This Experience Taught Us
This event reinforced something we have always believed:
Science matters — but so does compliance.
Communicating research clearly, safely, and responsibly is essential.
Today, every part of our communication and every educational article goes through strict internal review to ensure:
- accuracy
- regulatory compliance
- scientific integrity
- clarity for consumers
Our Commitment Going Forward
Crocin Rich® — supported by dozens of published clinical studies — is the foundation of our product line:
All our supplements are:
- manufactured in an NSF-certified, cGMP facility in New Jersey
- made with high-purity crocin at clinically meaningful levels
- formulated with transparent labels and no hidden blends
- backed by our long-standing commitment to quality and integrity
A Founder-Led Company Driven by Purpose
As a small, founder-led business, every decision we make is guided by:
- scientific evidence
- ethical responsibility
- a genuine desire to help people age better and live better
We are deeply grateful to our customers, partners, and the scientific community for supporting our mission.
And as always, our commitment continues: