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Welcome to the December edition of EAS-e-News.

This month, we’re exploring how modern food production methods, biotechnology, and advanced ingredient development are reshaping regulatory expectations. We also highlight key considerations for GRAS submissions and allergen testing, helping companies navigate emerging technologies with clarity and confidence.

Issue of the Month

Current Food Production Methods

By Lane Highbarger, EAS Consulting Group Independent Consultant,
adapted for EASeNews

Advances in microbiology and molecular biology have significantly reshaped how food ingredients are developed. Early gene-splicing tools introduced in the 1970s enabled researchers to transfer genetic material into microorganisms, laying the groundwork for today’s genome-editing techniques and modern fermentation systems.

From Traditional Fermentation to Modern Genetic Pathways

Initial innovations focused on inserting new genes into microbial hosts so they could produce specific ingredients. As sequencing, PCR, and genome-level editing advanced, scientists gained the ability to design entirely new biochemical pathways that allow microorganisms to generate ingredients outside their natural biology.

The Rise of Acellular and Enzyme-Only Systems

A growing area of innovation involves producing ingredients using isolated, highly optimized enzymes rather than living microorganisms. These systems can offer more control, reduced variability, and more predictable outcomes for ingredient manufacturing.

Why FDA Focuses on the Final Ingredient, Not the Production Method

Regardless of whether an ingredient is made through fermentation, genome editing, or acellular enzyme systems, FDA assesses the final product. Key criteria include:

• Purity
• Chemical identity
• Toxicological safety

These requirements apply to GRAS determinations and submissions such as FAPs, FCNs, NDINs, and CAPs.

Looking Ahead

As new production technologies emerge, manufacturers will have more tools for producing safe, consistent ingredients. Understanding these scientific pathways is essential for preparing clear, well-supported regulatory submissions that meet FDA expectations.

Under the Microscope

PCR & ELISA Allergen Testing: How Manufacturers Detect Hidden Risks

As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”

Undeclared allergens continue to drive recalls across food, supplements, and cosmetics. This month’s Under the Microscope examines how ELISA and PCR testing detect hidden risks.

Undeclared allergens remain one of the leading causes of food, supplement, and cosmetic recalls. To reduce risk, manufacturers rely on two core laboratory methods: ELISA, which detects allergenic proteins, and PCR, which identifies DNA from allergenic ingredients. Each method offers unique advantages depending on how a product is made, processed, and formulated.

ELISA is the preferred option for most routine allergen programs because it provides reliable quantification of intact proteins and is widely validated across food and supplement matrices. PCR is used when proteins may be degraded during processing or when ingredient blends are complex.

Both methods are effective tools for raw materials, finished products, and environmental swabs, and each requires validation in the specific product matrix to ensure accuracy. ISO 17025 accreditation is an important indicator that test methods, equipment, and analysts meet rigorous performance standards.

Read the full article to see how ELISA and PCR work, when each method is recommended, and what manufacturers should ask their lab to ensure results they can trust.

GRAS Services: Expert Support for Safe Ingredient and Packaging Submissions

FDA Submissions for Human and Animal Food, Ingredients, and Packaging Safety

Before an ingredient, packaging material, or color additive can be used in food, it must meet FDA’s safety requirements. For many companies, this means navigating pathways such as GRAS, Food Additive Petitions (FAP), Food Contact Notifications (FCN), New Dietary Ingredient Notifications (NDIN), or Color Additive Petitions (CAP).

Our services include

• Feasibility and data gap assessments
• Study design, protocol development, and CRO coordination
• Monitoring study conduct and outcomes
• Development of submission dossiers
• GRAS panel organization and self-determined GRAS conclusions
• Project management and FDA communications

With decades of experience and a strong record of successful submissions, EAS provides the expertise companies need to move products to market with confidence.

Helpful Resources

• FDA Submissions for Human and Animal Food Ingredient and Packaging Safety

• FAQ: GRAS and Submission Pathways

FDA and USDA Regulatory Updates

▪️FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment

To help keep our newsletter attractive and engaging for our readers, you’ll now receive a separate edition mid-month featuring our EAS in Action events and activities. You’ll continue to receive EAS-e-News early each month!

Consultant Corner

EAS offers over 150 independent consultants strategically located around the globe whose expertise provide core value for clients.

Issue of the Month Author

Lane Highbarger

EAS Consulting Group, EAS Independent Consultant

Lane Highbarger is a seasoned scientific and regulatory expert whose career spans nearly three decades at the forefront of food safety and innovation. Earning a Ph.D. in physical biochemistry from the University of Maryland in 1995, he went on to build an exceptional track record as a Regulatory Review Scientist at the U.S. Food and Drug Administration, within what is now known as the Office of Pre-Market Additive Safety.

At the FDA, Lane became widely recognized as the agency’s subject matter expert in food irradiation and played a leadership role in advancing the scientific review of GRAS notices, Food Additive Petitions, and Color Additive Petitions. Known for a meticulous, science-driven approach, he helped shape regulatory pathways for emerging technologies and contributed to ensuring the safety of ingredients used across the food industry.

In recent years, Lane’s expertise has been pivotal in the evaluation of infant formula submissions and biotechnology- and microorganism-focused GRAS notices. Today, he brings this depth of experience to authorship and consulting, translating complex regulatory science into accessible, authoritative insight for industry professionals, innovators, and readers alike.