FDA issues warning letters about botulism risk in canned desserts and illegal drug claims in supplements

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

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The FDA has issued warning letters to United King Foods Private Limited in Pakistan and Mother Earth Minerals, Inc. in Ogden, UT, for significant violations of federal food safety regulations. 

These violations, identified during inspections in 2024, raise concerns about potential health hazards, including botulism risks in low-acid canned foods and misleading health claims for dietary supplements.

The FDA emphasized that the violations could allow unsafe food and dietary supplements to enter the U.S. market. United King Foods’ inadequate thermal processing raises risks of botulism, while Mother Earth Minerals’ unsubstantiated health claims and CGMP failures could mislead consumers and compromise product safety. Both companies must take immediate corrective actions to comply with federal regulations.

United King Foods Private Limited
Karachi, Pakistan

The FDA conducted a Foreign Regulatory Assessment (FRRA) from Oct. 21 to 25, 2024, at United King Foods Private Limited’s low-acid canned food (LACF) and snack food manufacturing facility in Karachi, Pakistan. The assessment revealed serious violations of the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, rendering the company’s Gulab Jamun LACF products adulterated under the Federal Food, Drug, and Cosmetic Act.

Critical violations

• Unqualified process authority: The scheduled process for Gulab Jamun was not established by a qualified person with expertise in thermal processing, as required. The company’s heat penetration and distribution study used a single probe, inadequate for identifying the coldest spot in the product and retort.
• Inadequate deviation handling: Manufacturing records from May 17, Oct. 5, and Oct. 24, 2024, showed Fo values (a measure of thermal sterilization effect, indicating the time required to destroy microorganisms at 121.1 degrees C) below the minimum standard and failure to meet critical temperature and pressure requirements. The company did not reprocess or set aside non-conforming batches for evaluation.
• Initial temperature monitoring failures: The company measured the initial temperature of the last can loaded, not the coldest can, leading to deviations from the required 86.6 degrees C, undetected by staff.
• Lack of trained personnel: No staff had attended FDA-approved Better Process School training.
• Unreviewed production records: Continuous monitoring records for Gulab Jamun lacked signatures or dates to verify review, risking public health concerns.

FDA action and next steps
United King Foods responded on Nov. 12, 2024, promising corrective actions, including registering staff for Better Process School, conducting new heat studies, and developing standard operating procedures (SOPs) for deviations. However, the FDA found the response inadequate because of a lack of supporting documentation, such as training records or validation studies. The agency has requested an evaluation of all Gulab Jamun lots within shelf-life in the U.S. to ensure commercial sterility. Failure to comply could lead to refusal of product entry into the United States and placement on Import Alert #99-38, allowing detention without physical examination.

The full warning letter can be viewed here.

Mother Earth Minerals, Inc.
Ogden, UT

The FDA inspected Mother Earth Minerals, Inc.’s facility in Ogden, UT, from Aug. 7-15, 2024, and reviewed its website in September 2024 and January 2025. The inspection and website review identified significant violations, including unapproved new drug claims, misbranded drugs, and adulterated dietary supplements under the Federal Food, Drug, and Cosmetic Act.

Critical Violations

• Unapproved new drugs: The company’s Calcium, Magnesium, and Silver products are marketed with claims suggesting they treat or prevent diseases like cancer, multiple sclerosis, diabetes and infections, with statements such as “Silver is a potent natural antibacterial, antiviral, and antifungal.” These claims classify the products as unapproved new drugs because they lack FDA approval for safety and efficacy.
• Misbranded drugs: The products lack adequate directions for use, as their intended uses, such as treating serious diseases, require supervision by a licensed practitioner.
• Adulterated dietary supplements: The company violated Current Good Manufacturing Practice (CGMP) regulations by failing to:
  • Establish identity, purity, strength, and contamination specifications for components and finished products.
  • Create master manufacturing records for each product formulation.
  • Include required information in batch production records, such as batch numbers and quality control approvals.
  • Establish written quality control procedures.
  • Collect and hold reserve samples of distributed products.

FDA action and next steps
Mother Earth Minerals responded on Aug. 23, 2024, promising to create specifications, master manufacturing records, and quality control procedures within six months, but provided no supporting documentation. The FDA has requested a written response within 15 working days, detailing corrective actions. Failure to comply could result in seizure, injunction, or other regulatory actions.

The full warning letter can be viewed here.

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Source: https://www.foodsafetynews.com/2025/06/fda-issues-warning-letters-about-botulism-risk-in-canned-desserts-and-illegal-drug-claims-in-supplements/