Hardware Podcasts

72 - Talking Bioengineered Labeling Laws with Kate Kalivoda, CEO of Misty Pines Consulting

People of Packaging · 3 Sept 2021 · 46m

What this episode covers

Kate Kalivoda, CEO of Misty Pines Consulting, explains the National Bioengineered Food Disclosure Standard (NBFDS) and the Food Allergen Safety, Transparency, Education, and Research (FAST) Act, detailing how these regulations impact food labeling and compliance. She recounts her career transition from architectural drafting to packaging design, triggered by a non-compliant raisin package recall that highlighted a critical gap in regulatory knowledge between brands, retailers, and printers. Kalivoda describes how state-level GMO labeling laws, starting with Vermont, created interstate commerce issues that led to the rapid passage of federal law, and she warns mid-sized companies about the operational challenges of achieving compliance by the January 2022 deadline.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Misty Pines Consulting
Tools
Specright
Also
Vermont, NBFDS, FAST Act

Related episodes from other shows

Other shows on the same ground, closest first.

  • The Startup CPG Podcast · 57m

    #216 - Food Labeling Law 101 with Lauren Handel

    Lauren Handel, founder of Handel Food Law, explains the regulatory framework and litigation risks for CPG brands, distinguishing between FDA-regulated foods and USDA-regulated products. She details specific claim categories including nutrient content, 'natural,' 'organic,' and health benefits, emphasizing that consistency across packaging, websites, and advertising is essential to avoid costly class-action lawsuits. Handel advises founders to understand the difference between regulatory consultants and attorneys, noting that legal advice offers privilege and risk assessment that consultants cannot provide, while recommending third-party certifications to mitigate exposure to litigation.

    Certification & complianceMarketing & brand
    10 chapters

  • The Startup CPG Podcast · 28m

    R&D RADIO: Travis Zissu from Scale Food Lab

    Travis Zissu, founder of Scale Food Labs, an FDA-registered pilot facility in Golden, Colorado, explains how his company helps emerging CPG brands transition from benchtop formulas to scalable production. He details a rigorous process involving sourcing from commercial-grade suppliers, iterative prototyping, and stress-testing pilots by manipulating heat and stirring to uncover failure points before full-scale manufacturing. Zissu highlights current industry trends, including a supply chain shortage for beta-lactoglobulin (BLG) whey protein through 2027, the risks of GI distress with fiber-forward products, and the potential of cell-based meats. He emphasizes that founders must accept a '90% acceptance' threshold for launch, as home kitchen recipes rarely translate perfectly to industrial machinery.

    Prototyping & iterationSourcing & supply chain
    7 chapters

  • How I Built This · 1h 19m

    Bobbie: Laura Modi. How a Baby Formula Startup Took Market Share From Two Industry Giants

    Laura Modi, co-founder of Bobbie, explains how she disrupted the duopoly of Abbott and Mead Johnson in the U.S. infant formula market by launching a European-style, grass-fed formula. She details the company's early struggles, including a crippling FDA shutdown that forced a public apology and a pivot to a companion formula, and the subsequent 18-month regulatory course-correction with contract manufacturer Perigot. Modi also discusses the strategic decision to acquire Nature's One to own manufacturing capacity during the 2022 shortage, and how navigating federal oversight in Washington, D.C., became central to the company's growth and policy advocacy.

    Validation & product-market fitCertification & compliance
    6 chapters

  • The Startup CPG Podcast · 28m

    R&D RADIO: Non-GMO, Organic, or Gluten-Free? How to Decide Which Certifications Are Worth It

    Esther Levy, founder of Evolve Food Consultants, explains the complex trade-offs founders face when deciding on third-party certifications like USDA Organic, Non-GMO, and Gluten-Free. She highlights that while organic is theoretically possible, it is often impractical for early-stage brands due to scarce ingredient supply, high minimum order quantities, and the need for certified manufacturers. Levy advises using substantiated claims initially to avoid the high costs and logistical barriers of certification, using the difficulty of sourcing organic potatoes for chips as a key example. She also warns against unsubstantiated health claims, citing the Poppi lawsuit, and emphasizes that documentation and organization are critical for regulatory compliance.

    Certification & complianceSourcing & supply chain
    6 chapters

  • Let's Combinate · 1h 00m

    047 - "Truthful Not Misleading" with Darshan Kulkarni

    Darshan Kulkarni, an FDA regulatory attorney and Adjunct Law Professor at Drexel University, explains the distinction between regulatory and legal compliance in the life sciences industry. He details how the First Amendment influences US promotional compliance, particularly regarding off-label speech and the 'truthful not misleading' standard established by recent court cases. Kulkarni also discusses the operational differences between FDA divisions for drugs (OPDP) and devices (CDRH), noting the latter's limited enforcement resources, and highlights the implications of the Sunshine Act on physician interactions.

    Certification & complianceIntellectual property
    9 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by People of Packaging. The episode itself belongs to its publisher.