Amidst the growth in the healthcare and food industry, ensuring the safety and efficacy of products has become more crucial than ever. FDA approval, an integral part of this process, functions as a “quality assessment” by the United States Food and Drug Administration. In this article, GOL will delve into FDA approval and the products that require endorsement from the FDA.

What is FDA Approval?

FDA approval is a term referring to the acknowledgment by the United States Food and Drug Administration (FDA) that a product has met their standards. This signifies that the FDA has assessed and determined that the product is safe and effective for its intended use.

The FDA, a federal agency in the United States, is responsible for safeguarding public health by overseeing food, pharmaceuticals, medical devices, vaccines, cosmetics, tobacco, and other related products.

FDA approval is a crucial process designed to ensure that products available in the U.S. market are safe and effective for consumers. To attain FDA approval, products must adhere to stringent standards concerning quality, safety, and efficacy. These standards are formulated to protect consumers from products that could pose health risks.

Read more: How to get FDA approval? Tips for a Successful Application

Products requiring FDA approval prior to being marketed

New human drugs and biological products

The approval process for new human drugs and biological products by the FDA is a crucial step before they can be introduced into interstate commerce. Prior to marketing, companies are required to establish the safety and efficacy of their drugs or biological products for their intended use. Additionally, they must demonstrate their ability to manufacture the product in accordance with federal quality standards. An FDA approval signifies that the agency has assessed the benefits of the product against its risks for the intended use and has deemed it acceptable.

Biological products subject to FDA approval encompass therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, as well as those derived from plasma. Manufacturers are obligated to provide evidence of their capability to produce the drug or biological product in compliance with federal quality standards.

It is important to note that the FDA does not engage in the development of products prior to approval. Instead, FDA experts meticulously evaluate the outcomes of laboratory, animal, and human clinical testing conducted by manufacturers. Additionally, the FDA conducts lot release testing for numerous biological products, creating a real-time system for continuous monitoring of product quality through thorough review and testing.

Read more: What is biosimilar medicine? FDA Review and Approval Process

The FDA employs a risk-based, tiered strategy to regulate medical devices intended for human use

These devices are categorized by the FDA based on their level of risk, and the corresponding regulatory measures necessary to ensure their safety and effectiveness. Devices with the highest risk (Class III), such as implantable infusion pumps and mechanical heart valves, typically require FDA approval through a premarket approval application before being marketed. Manufacturers seeking approval for these devices must provide substantial and valid scientific evidence demonstrating a reasonable assurance of their safety and effectiveness for their intended purposes.

Moderate-risk medical devices (Class II), including dialysis equipment and various catheters, are generally “cleared” by the FDA for marketing when it is shown that the device is substantially equivalent to a legally marketed predicate device that does not necessitate premarket approval. Class II devices are typically subject to special controls, which may involve specific testing or labeling requirements specific to each device.

Devices with a low risk of harm to users (Class I), such as non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves, are only subject to general controls. Additionally, most Class I devices are exempt from premarket notification requirements.

The FDA employs a risk-based strategy for overseeing human cells and tissues

All human cells and tissues, collectively known as human cells, tissues, and cellular and tissue-based products (HCT/Ps), intended for use in individuals are subject to regulation to prevent the transmission of infectious diseases. Examples of HCT/Ps encompass bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.

For those HCT/Ps that present an additional risk due to their processing or intended use, FDA approval is required before they can be marketed.

It’s important to note that the FDA does not oversee the transplantation of vascularized human organ transplants, such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration (HRSA) is responsible for the oversight of the transplantation of vascularized human organs.

The inclusion of food additives in human food products

While the FDA does not mandate premarket approval for entire food products, it possesses the authority to approve specific ingredients before their incorporation into food or contact with food. This includes substances deliberately added to food, as well as those that migrate from materials in contact with food, such as food packaging, and color additives.

Companies seeking to introduce new food additives are obligated to furnish the FDA with evidence substantiating the safety of these additives. FDA experts meticulously assess the outcomes of relevant tests conducted by companies to ensure the safety of the food additive for its intended purpose. An approved food additive must be utilized in accordance with its approved uses, specifications, and any imposed restrictions.

Certain food ingredients, categorized as “generally recognized as safe” (GRAS) for their intended conditions of use by scientific experts, do not necessitate premarket approval from the FDA. The FDA has instituted a voluntary notification process, allowing a manufacturer to submit a conclusion asserting that the use of a particular ingredient is GRAS.

The FDA approves color additives used in FDA-regulated products

The FDA grants approval for color additives employed in products under its regulatory purview, encompassing usage in food (including animal food), dietary supplements, drugs, cosmetics, and certain medical devices. With the exception of coal-tar hair dyes, these color additives are mandated by law to undergo agency approval before being introduced to the market. Each color additive is permitted for use solely in adherence to its approved applications, specifications, and any imposed restrictions.

Throughout the approval procedure, the FDA scrutinizes safety data to verify the safety of a color additive for its designated purposes.

Read more: What You Need to Know About Food Color Additives

What doesn’t need FDA approval?

Facilities

The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.

While manufacturing facilities and contract manufacturers are typically inspected as part of the product application process for certain items requiring premarket approval, the FDA does not independently approve manufacturing facilities. Instead, the FDA is empowered to conduct inspections to confirm compliance with relevant current good manufacturing practices and other stipulated requirements, including a well-designed and controlled production process.

Unless exempt, owners and operators of domestic or foreign facilities involved in the production of food, drugs, and most devices must register with the FDA before exporting products to the U.S. Additionally, those establishments manufacturing blood products or cells, tissues, and cellular and tissue-based products are also required to register with the agency.

FDA is essential for mammography facilities, and their FDA registration, indicating adherence to stringent quality standards for mammography, must be prominently displayed where patients can easily view them.

Compounded drugs

Compounding is typically a process where a pharmacist or doctor blends ingredients to formulate medications tailored to the specific requirements of individual patients, especially those allergic to components in FDA-approved medicines or unable to ingest an FDA-approved pill.

It’s important to note that compounded drugs do not receive FDA approval. Consequently, the FDA does not undertake a premarket review of compounded drugs to assess their safety, effectiveness, or quality.

Tobacco products

Since there is no tobacco product deemed safe, the FDA does not apply its usual standard for evaluating medical products (safe and effective) to tobacco. Instead, the FDA regulates tobacco products based on a public health standard, taking into account the product’s risks to the overall population, including both users and non-users of tobacco products.

To legally sell or distribute a new tobacco product in the U.S., manufacturers must obtain authorization from the FDA. There are three pathways available for introducing a new tobacco product to the market: premarket tobacco product applications, substantial equivalence applications, or exemption from substantial equivalence requests.

It’s crucial to understand that receiving a marketing authorization from the FDA does not imply that the tobacco product is safe or “approved.” Rather, it signifies that the manufacturer has adhered to the legal requirements for bringing the product to market.

Cosmetics

Cosmetics, which include items like perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations, as well as their ingredients and labeling, are not subject to FDA approval.

However, there is one exception to this rule: color additives (excluding coal-tar hair dyes). While cosmetics do not undergo FDA approval, they must still adhere to safety standards for their intended use and be correctly labeled.

The FDA does not provide approval for medical foods

A medical food is specifically formulated to be consumed or administered enterally and is designed for the targeted dietary management of a disease or condition for which distinctive nutritional requirements, based on established scientific principles, are identified through medical evaluation. An example of a condition managed by a medical food is phenylketonuria, a genetic disorder where individuals may require medical foods formulated without the amino acid phenylalanine.

The use of a medical food is intended to be supervised by a physician and does not encompass products like meal replacements, diet shakes, or items for managing diseases, such as diabetes, which can be controlled through dietary modifications alone.

Medical foods do not undergo premarket approval by the FDA, but companies manufacturing them must comply with other requirements, including current good manufacturing practices and the registration of food facilities. While medical foods are not obligated to display a Nutrition Facts label, any statements on their labels or in other labeling must be accurate and not misleading.

Infant formula

The FDA does not grant approval for infant formula prior to its introduction to the market. However, manufacturers of infant formula are under the regulatory oversight of the FDA.

To ensure compliance with federal nutrient requirements and other regulations, infant formula manufacturers must register with the FDA and submit an infant formula submission before launching a new formula.

The FDA conducts annual inspections of all facilities involved in infant formula production, collecting and analyzing product samples. Additionally, new facilities are subject to FDA inspections. If the FDA identifies that an infant formula, whether adulterated or misbranded, poses a risk to human health, the formula’s manufacturer is mandated to initiate a recall.

Dietary supplements

The FDA does not have the authority to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be introduced to the market without notifying the FDA.

However, companies are obligated to submit a premarket safety notification to the FDA at least 75 days before marketing dietary supplements that contain certain “new dietary ingredients” not marketed in the U.S. before October 15, 1994.

Dietary supplement companies are responsible for ensuring the safety of their products before marketing and must comply with various labeling and quality requirements, including good manufacturing practices (GMP).

The FDA conducts inspections of facilities to ensure compliance and monitors adverse event reports related to dietary supplements. In cases where public health concerns emerge regarding the safety of a dietary supplement or its ingredients, the FDA has the authority to take action to safeguard the public.

The FDA does not provide approval for individual food labels, including the Nutrition Facts label

FDA regulations mandate certain labeling elements, including nutrition information, to be present on most foods, including dietary supplements. Additionally, any statements on food products must be accurate and not misleading, adhering to applicable regulatory requirements for the type of statement.

Manufacturers are required to include the serving size of the food and specific information about the nutrient content of each serving on the “Nutrition Facts” label (or on the “Supplement Facts” label for dietary supplements). This information is crucial for consumers to make informed choices about the nutritional content of the products they purchase.

The FDA does not approve structure-function claims on dietary supplements and other foods

Structure-function claims characterize the role of a food or food component, such as a nutrient, with the intention of influencing the structure or function of the human body. An example is the claim “calcium builds strong bones.”

Dietary supplement companies making structure-function claims on labels or in other labeling are required to submit a notification to the FDA. These claims on dietary supplements must include a disclaimer stating that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.

Conventional food manufacturers are not mandated by the FDA to notify the agency about their structure-function claims or to include a disclaimer. However, all such claims must comply with the law by being truthful and not misleading.

FDA jurisdiction and authority

The FDA retains jurisdiction and authority over various products, particularly in cases involving safety concerns, complaints, and adverse effects.

In instances of safety issues, consumer complaints, or adverse events related to a product, the FDA has the power to take actions. This may include requiring manufacturers to initiate recall actions or even shutting down manufacturing plants. The FDA can intervene if it becomes aware of:

• Product risks or harm events affecting consumers.
• Violations of Good Manufacturing Practices (GMP) requirements, such as those related to manufacturing sterility, product safety, testing, validation, secure packaging, and other quality control measures.

This regulatory oversight ensures that the FDA can respond effectively to situations that may pose risks to public health or compromise the quality and safety standards of regulated products.

In conclusion, FDA approval is a crucial process that ensures the safety of consumers when using products available in the U.S. market. This article has provided some basic information about FDA approval, including its definition, significance, and the types of products that require or do not require FDA approval.

To facilitate businesses’ access to the U.S. market, GOL offers high-quality and efficient FDA registration services. With an experienced team specializing in FDA registration for food, cosmetics, and medical equipment, GOL is committed to assisting your business in completing FDA registration procedures quickly and accurately.

GOL is the ideal choice for businesses looking to import or distribute their products in the U.S. Contact GOL now for a free consultation on FDA registration services!

Reference:

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Is It Really ‘FDA Approved’?