Did You Know September was a Busy Month for FDA?

The FDA was pretty busy during the month of September, issuing 7 Warning Letters.  What is the FDA you might ask?  The acronym FDA stands for United States Food and Drug Administration.  As the name suggests, they regulate Foods and Drugs in the United States.  They create regulations that help keep us safe and enforce resolving violations in companies that might be putting us in harms way.  The FDA offers preventative services such as routine testing and monitoring food-based companies and operates as an investigative service when a foodborne outbreak is identified.  They are kind of like the batman of the food industry.  Quietly lurking in the shadows until help is needed.

One of the tools the FDA holds in their proverbial tool belt is an official “Warning Letter.”  A Warning Letter is an official and public notice that is used when a manufacturer has “significantly violated FDA regulations.”  A Warning Letter identifies the violation.  This could be anywhere from poor manufacturing practices to routine problems found at the manufacturing facility, improper claims, or even incorrect directions for use.  This official notice makes it clear that the company must fix their problems and provides both directions and a timeline that the company will inform the FDA of how they will go about doing it.  The FDA will make sure that the proposed corrections meet the FDA’s expectations.  In short, it is a “fix this or else” communication.  Failure to comply will result in the FDA shutting down the facility.

When I say that 7 food companies received such notices in a short time period, this alarms me.  It takes quite a bit to get this far. Some of the names that came up are new.  Others are repeat offenders.

Elwood International, Inc

Elwood International, Inc of Copiague, New York was issued a Warning Letter September 27, 2018.  Elwood International is a manufacturer of condiments and sauces.  In addition to FDA samples of Elwood’s Fat-Free Low Sodium Ranch Dressing Artificial Flavor packaged in hermetically-sealed containers that the firm ships in unrefrigerated containers testing above pH 4.6 and containing water activity over 0.85, staff participating in the manufacture of food products did not complete approved courses that would allow them to legally work in the facility.

This was not the end of their infractions.  Their Warning Letter issued remarks on 8 different violations, including:

• Insufficient pest control. Dead rodents, rodent feces, and insect activity were found throughout the facility.
• Condensation from pipes above food preparation and food storage areas was found dripping and on top of jelly, mustard, and mayonnaise products at the facility.
• Shatter proof lights and light fixtures were not used above food preparation areas, which leaves food susceptible to contamination with extraneous material. This is a direct violation of FDA regulations.
• In additional to pitted floors, standing stagnant water, and holes investigators also observed unsanitary accumulation of food product on mixing blades and other parts of production equipment.
• Overflowed trash was observed in production areas. In one place, refuse was observed to be overflowing onto a pallet of raw materials.
• Inadequate precautions were taken to avoid contamination and cross-contamination when cleaning equipment between food types. Staff were observed resting containers on the floor that was covered with water, setting food surfaces directly on a drain, and allowing cleaning water to splash onto seals still loaded onto equipment that will be used to package the next batch of food product.
• An employee was observed using cleaning compounds and/or sanitizing agents that were not ensured to be adequate under the conditions of use.
• The facility failed to have equipment and hoses there were constructed to be adequately cleaned. In fact, during observation an improperly cleaned hose was used that contained food products from a previous batch.  The facility also did not ensure protection against cross-contamination of allergen foods, despite the facility handling food products that contain soy, eggs, and peanuts.

Vinill, Inc

Vinill, Inc of Brooklyn, New York was issued a Warning Letter on September 21, 2018.  Vinill is a seafood processing and distribution facility.  The major violation that renders the refrigerated, ready-to-eat, vacuum packaged, smoked paddlefish unsafe for consumption is failure to conduct a hazard analysis for each kind of fish or fishery product to determine potential food safety hazards that are likely to occur and implement a written HACCP plan to control any potential food safety hazards that might occur.

Best Nutrition Products, Inc.

Best Nutrition Products, Inc of Hayward, California was issued a Warning Letter on September 7, 2018.  Best Nutrition Products manufactures dietary supplements.  In addition to selling “unapproved new” or “misbranded” drugs that provide health claims not approved by the FDA and bears inadequate directions for its intended use without the safe administration by a licensed medical practitioner, the following violations were observed:

• The company failed to establish written procedures to handle product complaints.
• The company failed to establish and follow written procedures for holding and distributing operations.
• The company failed to establish and follow written procedures to handle returned dietary supplements.
• The company failed to provide written procedures and follow though with cleaning the physical plant and for pest control.
• The product Garcinia Slim Fit & Weight Loss 75% HCA, Gymnema, Sylvetre, and Shilajit Fulvic Acid dietary supplement was found deficient in two major requirements. The product failed to declare the “common or usual” name of each ingredient and a domestic address or phone number was not included on the packaging that would allow a consumer to report a serious adverse event with the dietary supplement.

Rose Acre Farms, Inc.

Rose Acre Farms, Inc of Seymour, Indiana was issued a Warning Letter on September 6, 2018. Rose Acre Farms is a shell egg farm and processing plant.  If this name sounds familiar, it should.  This is the same farm that was linked to a Salmonella outbreak that sickened 45 people across 10 states that prompted the largest egg recall since 2010.  The same problems persist, prompting another Warning Letter from the FDA.  In addition to unacceptable rodent activity, samples from many areas around the processing plant and farm were positive for Salmonella Braenderup and Salmonella Heidelberg.  Other unsanitary and poor employee practices were observed, including:

• Investigators observed employees not following the firm’s sanitation procedure used for cleaning the Egg Orientor Belt.
• During observation, investigators observed employees not performing a sanitizing step following a wash step of equipment.
• Incorrect concentration of sanitizer was used on food contact equipment.
• Condensation was observed dripping from the ceiling, pipes, and down walls onto production equipment and pooling onto floors in foot and forklift traffic pathways.
• Several maintenance and sanitation employees were observed placing food contact surfaces onto the floor, pallets, and on equipment that contained a visible accumulation of grime and food debris before placing it into service.
• Maintenance employees were observed dragging non-food contact equipment through grime and food debris and then placing it on top of food contact surfaces.
• Flying insects were observed throughout the plant and seen landing on food, food contact surfaces, and food production equipment.

Samuel Zimmerman

Samuel Zimmerman of Penn Yan, New York was issued a Warning Letter on September 5, 2018.  Samuel Zimmerman is responsible for a shell egg farm. The farm is in violation for not implementing a written Salmonella Enteritidis prevention plan as required by the FDA in addition to other violations, including:

• Established rodent monitoring methods are inadequate.
• Established fly monitoring methods are inadequate.
• The Farm failed to conduct Salmonella Enteritidis testing in the poultry house where laying hens are 40 to 45 weeks old as required.

Environmental Trade Inc.

Environmental Trade, Inc , of Eatonton, Georgia was issued a Warning Letter on September 4, 2018.  Environmental Trade manufacturers Blue Ridge Cat products.  Following the death of two kittens who consumed Blue Ridge Beef Kitten Grind for Cats, necropsy samples tested positive for Salmonella.  This Salmonella matched samples taken from an unopened package of that cat food, linking Environmental Trade to the kittens’ deaths.  Additional sampling uncovered Listeria monocytogenes in the package as well.  This prompted an inspection of the facility were additional samples tested positive for Salmonella and Listeria monocytogenes.  The firm indicated after previous investigations that an antimicrobial additive was used to minimize risk.  This additive is not effective and not regulated as acceptable by the FDA.

Natural Sea Products, Co.

Natural Sea Products Co., of Thailand was issued a Warning Letter on September 4, 2018.  Natural Sea Product is a Seafood Processing Facility.  An inspection of the facility revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations required by the FDA.  Additional violations include:

• Failure to conduct a hazard analysis for each type of fish and fishery product produced.
• Failure to define each possible critical control point for products produced at the facility.
• Failure to establish critical limits in the firms HACCP.

The FDA will continue to monitor responses to these Warning Letters.  Personally, I hope that issues resolve before an unfortunate outbreak and costly recall is required.  It is in everyone’s best interest for companies to comply.

By: Heather Van Tassell, Contributing Writer (Non-Lawyer)