The phrase “FDA Approved” frequently appears on product labels, particularly for items promoted online. But are these products genuinely approved by the FDA? The FDA only grants approval to a product following a thorough assessment of its safety and efficacy. The majority of products are not mandated to obtain FDA approval before being marketed in the USA; rather, they only need to be registered with the FDA. Furthermore, the FDA does not grant approval to manufacturing facilities; instead, it might perform audits or inspections to verify compliance with Good Manufacturing Practices (GMP). It’s important to note that passing an FDA audit or inspection without any issues of non-compliance does not equate to an FDA endorsement of the facility.

In this article, let’s explore with GOL about key tips and strategies to help streamline your FDA approval process and increase your chances of securing regulatory clearance.

FDA Approval of Food and Beverages

The FDA does not grant approval to food and beverage products. Instead, food facilities are required to register with the FDA prior to distributing their products in the United States, but this registration should not be mistaken for an endorsement or approval of the facility or its products by the FDA.

Registration with the FDA for food serves dual purposes: it equips the agency with essential contact details for both routine and emergency communications, and it provides the FDA with information about the facility’s products and operations. This information is crucial for the FDA to prioritize inspection schedules based on the assessment of potential food safety risks.

An exception to the general rule of FDA non-approval for food and beverages applies to new food additives, which do require FDA approval. Manufacturers seeking to incorporate new food additives into their products must conduct thorough testing to demonstrate the additive’s safety to the FDA’s satisfaction.

While food facilities are mandated to register with the FDA and categorize their products, receiving an 11-digit registration number upon successful registration, they are also responsible for ensuring their product labels meet FDA labeling requirements. It’s important to note that the FDA does not review or approve these labels; the onus is on the manufacturer or distributor to ensure their product labels are fully compliant with FDA regulations.

Read more: FDA approved vs FDA cleared: The differences you need to know

FDA approval for Dietary Supplement

Dietary supplements do not require FDA approval, except for new dietary ingredients which necessitate FDA approval. The primary emphasis for dietary supplements lies in regulating new dietary ingredients. To be legally sold in the United States, a new dietary ingredient must undergo FDA approval, adhering to safety and effectiveness criteria.

However, the lack of a requirement for FDA approval of the supplements themselves does not mean that there are no regulatory obligations. Dietary supplement manufacturers must adhere to several key regulatory requirements, including facility registration with the FDA, compliance with Good Manufacturing Practices (GMP), and adherence to strict labeling and ingredient guidelines. These regulations are designed to ensure the safety and proper labeling of dietary supplements available to consumers.

A notable exception to the general rule regarding FDA approval involves dietary supplements that make claims related to treating, diagnosing, preventing, or curing diseases. When a company markets a dietary supplement with such health claims, the product may then fall under the purview of drug regulations. In such cases, the product would be required to undergo the FDA approval process similar to pharmaceutical drugs if it does not meet specific regulatory exemptions. This ensures that any product making significant health claims has been rigorously tested for safety and efficacy, providing an additional layer of consumer protection against potentially misleading or harmful products.

FDA Approval of Drug Products

The FDA’s approval process for drug products hinges on whether a new drug aligns with an established over-the-counter (OTC) monograph. These monographs detail specific conditions under which the FDA has previously determined a drug to be safe and effective for consumer use.

When an OTC monograph is finalized, manufacturers are then permitted to market their OTC drugs that meet the monograph’s criteria without needing direct FDA approval. Additionally, the FDA exercises enforcement discretion, allowing the marketing of certain drugs without formal approval, provided they adhere to tentative final monographs.

However, for new drugs that do not fit within an existing monograph, obtaining FDA approval is mandatory. This process requires drug manufacturers to undertake extensive testing, including laboratory, animal, and human clinical trials, and to submit their findings to the FDA for review. The FDA evaluates these submissions, focusing on whether the benefits of the drug for its intended use outweigh any potential risks. Should a new drug be marketed without conforming to an OTC monograph and without obtaining FDA approval, it would be considered the marketing of an unapproved new drug, a violation under the Food, Drug, and Cosmetic Act (FD&C Act).

While the FDA is responsible for the approval of new drugs, it is important to note that the agency does not approve compounded drugs. Drug establishments are required to register with the FDA and list their products; however, this registration and listing process does not equate to an FDA endorsement of the establishment or its product offerings.

FDA Approval of Medical Devices

The FDA categorizes medical devices into three risk-based classes: Class I, Class II, and Class III, with the classification determined by the potential risk the device poses to patients. Among these, Class III devices represent the highest level of risk and are the only category requiring FDA premarket approval. Manufacturers of Class III devices are tasked with proving to the FDA that their products are both safe and effective, offering reasonable assurance of their performance.

For Class I and II devices, which are considered to pose lower risks, the FDA does not require premarket approval. However, unless specific exemptions apply under the Food, Drug, and Cosmetic Act (FD&C Act), these devices must undergo premarket notification, commonly referred to as a 510(k) submission. This process involves demonstrating that the device is substantially equivalent to another device that is already legally on the market in terms of safety and effectiveness. If the FDA concludes that the device meets these criteria, it will grant clearance for the device to be marketed. It’s important to note that this clearance is distinct from an approval, as it is based on the device’s equivalence to existing products rather than an independent assessment of its safety and efficacy.

Similar to the procedures for food, beverage, dietary supplements, and drug products, medical device establishments are required to register their devices with the FDA and list them. However, this requirement for registration and listing does not constitute FDA approval of either the establishment or its medical devices.

Read more: Explaining the Differences of the 3 FDA Medical Device Classes

FDA Approval of cosmetic

FDA doesn’t require cosmetic products or their ingredients prior to market release, with color additives being the sole exception to this rule (refer to the section on FDA Approval of Color Additives for more details).

Historically, cosmetic companies were not required to register with the FDA; their responsibility was merely to ensure their products were safe for intended use. However, the landscape shifted with the enactment of the Modernization of Cosmetic Regulations Act (MoCRA) on December 29, 2022. Under MoCRA, the FDA now exercises increased regulatory authority over the cosmetics industry, necessitating cosmetic companies to register with the FDA.

It is critical to understand that FDA registration for cosmetic companies does not equate to FDA approval. The process of registering a cosmetics facility simply provides the FDA with visibility into the operations of the facility and the products it introduces to the U.S. market.

Moreover, similar to dietary supplements, cosmetics may face exceptions concerning FDA approval. If cosmetic labeling makes claims that fall under the purview of drug regulations, the FDA may classify the cosmetic product as a drug. In such instances, the product may then be subject to FDA approval requirements, as outlined in the section concerning FDA Approval of Drug Products.

FDA Approval of Color Additives

The use of color additives in food, drugs, cosmetics, and certain medical devices necessitates FDA approval. Additionally, color additives deemed high-risk must undergo FDA certification for each batch produced. These additives are permitted only within the bounds of their sanctioned applications, specifications, and regulatory limitations.

Should a product incorporate color additives that have not received FDA approval, it is classified as adulterated according to the Food, Drug, and Cosmetic Act (FD&C Act). Such adulterated products are prohibited from distribution in interstate commerce within the U.S. Furthermore, cosmetic products found to contain violations related to color additives may be subject to detention at U.S. ports of entry.

Labeling Products Approved by the FDA

For products such as drugs and medical devices that necessitate FDA approval, manufacturers are permitted to use the designation “FDA Approved” on their product labeling, provided they have received formal approval confirmation from the FDA through an approval letter.

It is crucial to note that the FDA logo must not be used on product labeling, even for FDA-approved items. Utilizing the FDA logo could suggest endorsement by the FDA, which is not allowed and may infringe upon federal regulations. The unauthorized application of the FDA logo on product labeling could expose manufacturers to civil or criminal penalties.

Regardless of approval status, entities like food facilities, pharmaceutical companies, medical device manufacturers, and cosmetic firms are required to adhere to the FDA’s Current Good Manufacturing Practices (CGMPs) and specific labeling guidelines. For those products that do require FDA approval, such as certain pharmaceuticals and medical devices, the product’s labeling is considered approved upon the product’s approval. Generally, though, product labels are not directly approved by the FDA.

Given the vast number of products not subject to premarket approval, one might wonder about the FDA’s oversight mechanisms. The FDA maintains regulatory control over products through regular inspections of facilities and randomized examinations of shipments at U.S. borders, ensuring compliance with its standards.

GOL – A reputable provider of FDA registration services

FDA registration can be a complex and time-consuming process for businesses. At GOL, we are committed to assisting businesses in the food and beverage, pharmaceutical, medical device, and cosmetics industries comply with the regulations of the US FDA. We can support you in registering your company with the FDA, listing your products with the agency, and reviewing product labels to ensure compliance with FDA regulations. Our team of management experts is also available to assist in submitting color additive petitions to the FDA for certification of color batches. Contact us today for detailed support and advice!

References: 

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