Part I: An Overview of the Food & Drug Administration
What is the FDA?
The Food & Drug Administration (commonly known as the FDA) is an agency within the federal government.
This agency is in charge of overseeing the safety of medical devices, drugs, and the majority of food.
According to the FDA, it has five key responsibilities, which include:
- Protecting public health by regulating the foods which fall under its jurisdiction to ensure that they are “safe, wholesome, sanitary, and properly labeled” and ensuring that drugs, vaccines, medical devices, and other biological products are both effective and safe for human use.
- Keeping the public safe from radiation from electronic products
- Regulating all tobacco products
- Ensuring the safety and proper labeling of dietary supplements and cosmetics
- Assisting in speeding innovations in products in order to advance public health
What industries are regulated by the FDA?
Due to the wide scope of its regulatory authority, the FDA regulates eight main industries.
However, the FDA’s responsibilities are very similar to those of several other government agencies, which can often cause confusion among consumers.
Although this list is not inclusive, below are the eight industries most commonly regulated by the FDA.
The FDA regulates approximately 80 percent of the food supply within the United States, with the exception being foods that are protected by the Department of Agriculture including poultry, certain egg products, and meat from livestock.
Some of the foods that fall under the FDA’s jurisdiction include bottled water, infant formulas, food additives, and dietary supplements.
The drugs that are regulated by the FDA include both prescription and non-prescription drugs intended for human or veterinary use.
Aside from food and drugs, the FDA also regulates medical devices including dental devices, prosthetics, surgical implants, technologies including pacemakers, and more simple products like bedpans and even tongue depressors.
Biologics, medical treatments that are developed using blood or tissue, are another industry that the FDA oversees.
These products include insulin, vaccines, allergenics, immune therapies, and more.
Some of the common products that fall into the category of cosmetics include perfume, skin moisturizers, skin cleansers, nail polish, and the color additives used in makeup.
The FDA has been involved in the regulation of some tobacco products since 2009.
These include not only cigarettes, but also smokeless tobacco, cigarette tobacco, and roll-your-own tobacco.
Industries producing electronics that emit radiation are controlled by the FDA.
This includes x-ray equipment, sunlamps, microwaves, lasers, mercury vapor lamps, and ultrasound machinery.
Finally, the FDA also has regulatory authority over certain veterinary products including pet food, drugs, and devices for use in the veterinary industry, and feed for livestock.
Inside the FDA’s regulations of the food and drug industries
Of these eight industries overseen by the FDA, the food and drug industries are probably the two which consumers encounter on a daily basis.
But what, exactly, does the FDA do to regulate within these industries?
And what specific rules and regulations are the most important to the agency?
How the FDA ensures safety within the food industry
When it comes to food, there is a wide range of areas regulated by the FDA.
Some of these key focus areas include:
- Overseeing the registration of food facilities
- Enforcing the current good manufacturing practices
- Inspecting imports and exports
- Regulating retail and food service industries
- Protecting the nation’s food supply
- Analyzing and controlling hazards (including those that are chemical, biological, and physical)
- Administering the Food Safety Modernization Act (FSMA)
How the FDA regulates the pharmaceutical industry
The FDA oversees several aspects of the pharmaceutical/drug industry with some of the agency’s regulatory responsibilities including:
- Overseeing the drug registration and listing system
- Providing surveillance of the pharmaceutical industry
- Ensuring all imports and exports comply with FDA guidelines
- Regulating the drug supply chain integrity
Whether it involves registering food facilities or pharmaceutical companies, regulating food service and drug production industries, or enforcing proper manufacturing practices, a big part of what the FDA does, ensures that food and drug industry professionals are adhering to guidelines that ensure public safety.
Oftentimes this comes down to more than just common sense safety guidelines, like hand washing, sanitation, or refrigeration.
Instead, it deals with every aspect of the food production process, with material handling equipment being a key part of ensuring a safe finished product.
This means that in addition to regulating products (e.g. food, drugs, etc.), the agency also considers the environment in which the product was manufactured to ensure that good manufacturing practices were followed throughout every step of the process.
Part II: What you need to know about material handling solutions and food contact substances
When it comes to the design and construction of the equipment, utensils, and linens used in food processing and drug manufacturing facilities, the FDA has very clear guidelines in place surrounding five key areas:
- Durability & Strength
When choosing the material handling solutions and food contact substances for a facility, it is of the utmost importance to consider these five regulation areas, to ensure your facility is fully in compliance with the law.
What are material handling solutions made of?
Traditionally the material handling solutions used in the food and pharmaceutical industries have been made of metal, wood, cardboard, and, more recently, plastic.
This equipment can be anything used to handle any part of the food or drug being manufactured, such as bulk containers used for transporting the product.
It might not seem like materials used to construct the equipment that the food or drugs come in contact with during the manufacturing practice matter.
However, in reality, the integrity of the carts, pallets, bins, and other equipment used in the production of food and drugs for human consumption play an important role guaranteeing a safe and effective final product.
For instance, if a wooden pallet shatters during the food or drug manufacturing process, small splinters can easily make their way into the finished product, posing a risk to consumers across the nation.
Or, if a metal cart that is used during production begins to rust from being kept in a damp manufacturing environment, that rust has the potential to compromise the integrity of the facility producing food and/or drugs for public consumption.
Because of this, the FDA closely regulates the material handling solutions used by both food and drug manufacturers.
Fortunately, in recent years, many innovations have been made when it comes to material handling solutions such as carts, bins, and pallets — making the food and drug industries safer than ever.
When it comes to the material handling equipment used in food and drug manufacturing, there are five main options, each of which has pros and cons for meeting the rules and regulations laid out by the FDA.
These are illustrated in the below table.
- Able to handle heavy loads
- Easy to repair
|- Fire hazard
- Splintering can damage and/or contaminate product
- Sanitation issues due to rot, mold, bacteria, and fungus
- E.Coli and listeria risks
- Easy to sanitize and clean
- Doesn’t attract pests
|- Prone to rust and corrosion
- More expensive than other options
|Plastic||- Easy to clean and sanitize|
- Hardware free
- Doesn’t attract pests
|- Difficult to repair
- More cost up front than wood or cardboard options
|- Cannot be sanitized or cleaned
- Lacks structural integrity
What are food contact substances?
Material handling solutions such as utility carts, shipping containers, and pallets oftentimes fall into what the FDA refers to as food contact substances (FCS).
These food contact substances are defined by the agency as “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.”
If your equipment will be in contact with food, it is key to ensure that it meets the FDA’s FCS guidelines.
FDA material use limitations
The FDA also has strict material use limitations in place for food contact surfaces used in the manufacturing and food handling process.
Although these materials may be fine for certain aspects of food manufacturing and processing, it is important to familiarize yourself with the specific restrictions surrounding these materials, including:
- Cast iron
- Galvanized metal
- Non-stick coatings
Part III: How to choose the best material handling solution for your industry based on FDA rules and regulations
As you can see, material handling solutions such as bulk containers, shipping containers, pallets, and bins can be manufactured from a variety of materials — all of which have different benefits and drawbacks.
To better understand which materials are best when it comes to complying with FDA rules and regulations, it is important to look at how these different types of equipment are used in the food manufacturing process, and what the FDA regulates within each of these phases.
Manufacturing of food and drugs
The Current Good Manufacturing Practices (also known as CGMPs) laid out by the FDA have a lot to say about the equipment used during the manufacturing of food and drugs.
According to the CGMPs, when it comes to the equipment used in food and drug production, the FDA is most concerned with:
- Enforcing “expectations for the design, construction, and maintenance of equipment and utensils so as to ensure sanitary conditions.”
- Regulating sanitation and cleaning of equipment and utensils to prevent contamination
- Addressing pest control in manufacturing facilities
As far as the cleanability and sanitation of food contact surfaces go, these surfaces are required to meet five main criteria including being:
- Free of any cracks, breaks, open seams, inclusions, pits, and other similar imperfections
- Free of sharp corners, crevices, and internal angles
- Finished in a way that includes smooth joints and welding
- Accessible for inspection and cleaning either without being disassembled or by being easily disassembled.
Takeaway: When choosing material handling solutions for food and pharmaceutical manufacturing facilities it is of the utmost importance to choose well-designed equipment that can be easily cleaned and sanitized that also minimizes the risk of pest control issues.
Storage of food and drugs
The FDA also regulates the storage of food and drugs in the manufacturing process making it critical that bulk containers and pallets used to store materials intended for human consumption comply with the agency’s guidelines.
According to the CGMPs, when it comes to the equipment used to store food and drugs meant for human consumption, the FDA is most concerned with:
- Ensuring that finished food products are “stored and distributed under conditions that protect against physical, chemical, and microbial contamination.”
- Guaranteeing that storage containers (as well as the product stored in them are “protected from deterioration.”
Takeaway: It is key to ensure that pallets and bulk containers used for storage protect the finished product from contamination and deterioration.
Transportation of food and drugs
The FDA’s regulation of food and drug safety doesn’t end once a product leaves its production facility.
Instead, the FDA has thorough guidelines surrounding “problem areas where food may be at risk for physical, chemical, or biological contamination during food transport.”
As you can probably imagine, many of these regulations have to do with the shipping containers, pallets, and other equipment used during transit.
Some of the key areas regulated by the FDA during food and drug transport include:
- Ensuring proper packaging materials are used to transport food and drugs
- Evaluating the quality of pallets used during transit
- Regulating the sanitation of loading equipment
- Limiting the risk of cross-contamination
- Enforcing pest control in storage and shipping areas
Takeaway: It is important to rely on quality pallets and bulk shipping containers that ensure sanitation and minimize the risk of contamination or pest control issues.
Storage of personal items
In addition to the materials used in the manufacturing, storage, and transportation of food, the FDA also regulates dressing areas and locker rooms used by employees.
According to the 2017 FDA Food Code personal items such as street clothing, purses, and bags can contaminate food, food-contact surfaces, and food handling equipment.
Due to the hazard posed by personal items, the Code dictates that “Proper storage facilities are required for articles such as purses, coats, shoes, and personal medications.”
The lockers used to store these items can easily become contaminated if they are not regularly cleaned and sanitized.
This makes it essential to choose a durable material, such as plastic lockers, that will not rust or corrode over time, posing sanitation risks to food and drug manufacturing facilities.
When people think of the FDA, material handling solutions are seldom the first thing to come to mind.
However, as you can see, the material handling solutions and food contact substances used in food and drug manufacturing facilities are key to ensuring a safe finished product for human consumption.
Because of this, it is essential to become familiar with the specific rules and guidelines laid out by the FDA and to invest in high-quality materials that will ensure the integrity of your product.