FDA Issues Major Warning to Hearthy Foods Over GMP Violations and Collagen Misbranding

On February 10, 2026, the FDA issued a formal warning letter to Hearthy Foods, Inc., a Los Angeles-based dietary supplement and food manufacturer, for significant violations of Current Good Manufacturing Practice (CGMP) regulations and product misbranding. The unannounced inspection, conducted from March 19 through April 14, 2025, at the company's facility located at 2043 Imperial Street, Los Angeles, CA 90021, identified serious deficiencies in hazard analysis, sanitation controls, and labeling accuracy. The violations underscore FDA enforcement against manufacturers failing to meet safety standards for ready-to-eat whey protein isolate and collagen products.

What Happened

The FDA's warning letter addressed to owner Riaz A. Surti details multiple manufacturing violations discovered during the March-April 2025 inspection. The FDA's investigator issued Form 483 (Inspectional Observations) at the close of the inspection on April 14, 2025. Hearthy Foods submitted two written responses—dated April 24, 2025, and August 11, 2025—but the FDA determined the violations were not adequately corrected or addressed, prompting the formal warning letter.

According to the FDA, Hearthy Foods' ready-to-eat (RTE) whey protein isolate is classified as adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, meaning it was "prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth or may have been rendered injurious to health." The company also failed to implement required preventive controls under the Food Safety Modernization Act (FSMA) rules that govern dietary supplement and food manufacturers.

What the Source Says

The most critical violation concerns Hazard Analysis and Risk-Based Preventive Controls under 21 CFR Part 117, Subpart C. The FDA documented that Hearthy Foods did not conduct a formal hazard analysis to identify and evaluate known or reasonably foreseeable hazards—specifically, recontamination with environmental pathogens such as Salmonella and Listeria monocytogenes. Because the facility processes RTE whey protein isolate that is exposed to the environment and handled by employees, and because the packaged product does not receive any further lethal treatment or formulation control to minimize pathogens, the FDA concluded that any knowledgeable person in food manufacturing would identify pathogenic contamination as a hazard requiring preventive controls.

According to the warning letter: "The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens." This means the whey protein product relied on sanitation and process controls that were either missing or inadequate. The FDA also identified failures in sanitation procedures, practices, and processes required to maintain the facility in a condition adequate to "significantly minimize or prevent hazards such as environmental pathogens and biological hazards." Beyond contamination risks, the FDA cited misbranding of collagen products, indicating that label claims or ingredient disclosures did not comply with regulatory requirements.

Beyond the Headline

This enforcement action reflects sustained FDA effort to police dietary supplement and conventional food manufacturers that fall short of CGMP and FSMA compliance. The Food Safety Modernization Act rules, finalized in 2018, require owners and operators of covered facilities to conduct hazard analysis and implement preventive controls—standards that apply to dietary supplements as well as conventional foods. Warning letters represent a critical enforcement tool: they signal that the FDA has documented violations and expects corrective action within 15 business days. Failure to comply can result in product seizure, injunction, or criminal referral.

Hearthy Foods' violations—spanning inadequate hazard assessment, missing sanitation controls, and product misbranding—are among the most common deficiencies the FDA identifies during food and supplement facility inspections. The collagen product misbranding violation suggests that label claims may have overstated benefits or failed to include required warnings. Accurate labeling is essential because consumers rely on these representations to make informed choices and assess compatibility with their own health conditions and medications.

What This Means for Consumers

Consumers who have purchased Hearthy Foods' whey protein isolate or collagen products should review their purchases immediately. If you currently use a Hearthy Foods product, discontinue use until the company publicly confirms corrective actions. The documented risk is environmental pathogen contamination—specifically Salmonella or Listeria monocytogenes—which can cause foodborne illness with symptoms including diarrhea, fever, abdominal cramps, and in severe cases, hospitalization or systemic infection. Pregnant women, young children, elderly individuals, and immunocompromised people face heightened risk of severe illness.

For consumers seeking collagen or whey protein supplements, prioritize manufacturers with verified third-party testing (NSF Certified for Sport, Informed Choice, or USP verification). When evaluating any dietary supplement, check the FDA's warning letters database to confirm the manufacturer has no recent enforcement actions. If you are pregnant, young, elderly, or immunocompromised, consult your healthcare provider about the appropriateness of resuming any unfamiliar supplement brand after confirming the manufacturer's compliance status.

What to Watch Next

The FDA typically allows 15 business days from the warning letter date (February 10, 2026) for Hearthy Foods to submit a formal response outlining corrective actions. Key milestones to monitor include: (1) publication of Hearthy Foods' corrective action plan, if made public; (2) a follow-up FDA inspection to verify that hazard analysis, sanitation controls, and preventive controls are now in place; (3) any product recalls or voluntary withdrawals announced by the company; and (4) whether the FDA escalates enforcement to seizure, injunction, or referral to the U.S. Department of Justice. Consumers and healthcare practitioners should check the FDA's warning letters database and Hearthy Foods' website for updates on product safety and compliance status.