Comment 0Times Lookup 432psc Date Created 23-07-26 16:37
Comment 0Times Lookup 432psc Date Created 23-07-26 16:37
Topic: misuse of "FDA Approved" statement and FDA logo
< What does FDA approve or regulate? >
What does FDA approve or regulate?
- Maybe you saw those words- FDA approved, FDA cleared, FDA certified and FDA authorized on a company’s website or in a commercial promoting a product or treatment.
- The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation but not all those products undergo premarket approval.
- Businesses must not promote and/or advertise products outside the FDA-cleared or approved indications for use. Otherwise, it could mislead consumers and it is an allegation of regulatory misconduct. And the consumers should be able to distinguish between FDA approved and FDA regulated.
FDA doesn't approve the below, but businesses or consumers often misunderstand that FDA does:
- • compounded drugs
- • tobacco products
- • cosmetics
- • medical foods
- • infant formula
- • dietary supplements
- • food label, including the Nutrition Facts label
- • structure-function claims on dietary supplements and other foods
- The FDA doesn’t approve facilities. Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. But owners and operators of facilities must register with the FDA before exporting products to the U.S. (Mammography facilities must be FDA-certified.)
- But the FDA approves new human drugs, biological products, food additives in food for people, color additives used in FDA-regulated products.
- The FDA uses a risk-based approach for medical devices for people. Also, The FDA uses a risk-based approach for human cells and tissues intended for use in people. FDA approval before marketing may or may not be required depending on the risk.
< FDA regulation of Food, Cosmetics and medical device >
FDA regulation of Food, Cosmetics and medical device
For Food :
- • Although the FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in food or intended to contact food. Those include food additives (substances added intentionally to food, as well as substances that migrate to food from food contact products such as food packaging), and color additives.
- • Certain food ingredients, such as those that are considered “GRAS(generally recognized as safe)" for their intended conditions of use by scientific experts, do not require premarket approval by the FDA.
- • Although the FDA does not approve individual food labels prior to sale be marketed, FDA regulations require that any statements on food product must be truthful and not misleading.
For cosmetics :
- • Generally, products and ingredients, except for color additives and those ingredients that are prohibited or restricted by regulation, do not require FDA approval before being placed on the market. But there are laws and regulations that apply to cosmetics on the market in interstate commerce. The two most important laws regulating cosmetics are the Federal Food, Drug, and Cosmetic Act(FD&C Act) and the Fair Packaging and Labeling Act(FPLA). FDA can take enforcement action against products marketed that do not comply or against companies or individuals that violate the law and regulations.
For medical devices :
- • In general, business or facilities related to the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA.
- • It is important to note that the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices. Also, they do not receive a “Certificate of FDA Registration” from the FDA, even if their facilities and devices are registered with FDA.
- • Occasionally, some firms sell medical devices in the United States alongside “FDA registration certificates,” which includes the FDA logo, pictures, and information about the medical device, often have the look of an official government document. However as mentioned above, FDA does not issue certificates for medical device registration.
< Misuse of the FDA’s logo >
Misuse of the FDA’s logo
- The FDA’s logo is for official government use only and not for use on private sector materials. The FDA’s logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service. Also, the FDA logo cannot be used in combination with other elements to create a logo for an office or program. Unauthorized use of the
- FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
< Types of FDA Enforcement Actions >
Types of FDA Enforcement Actions
The objective of FDA regulatory programs is to assure compliance with Federal Food, Drug, and Cosmetic Act. Specific enforcement action activities include actions to correct and prevent violations, remove violative products or goods from the market, and punish offenders. The type of enforcement activity FDA uses depends on the nature of the violation :
- ① Warning letters : sent to the individuals or firms, advising them of specific noted violations.; These letters request a written response as to the steps which will be taken to correct the violation. These letters constitute one form of warning that can be issued under current Agency policy.
- ② Seizure : An action brought against an FDA-regulated product because it is adulterated and/or misbranded within the meaning of the Act. The purpose of such an action is to remove specific violative goods from commerce.
- ③ Injunction : An order by a court that requires an individual or corporation to do or refrain from doing a specific act. FDA may seek injunctions against individuals and/or corporations to prevent them from violating or causing violations of the Act.
- ④ Criminal prosecution : may be recommended in appropriate cases for violation of Section 301 of the Act.; Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.
- ⑤ Criminal Fines for Food Drug and Cosmetic Act Violations
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