What Does FDA Regulate?
The United States Food and Drug Administration (FDA) regulates many different products beyond what their name suggests of food and drug. FDA also regulates cosmetics, dietary supplements, homeopathic drugs, medical devices, laser devices, tobacco products, vaccines, blood and biologics, animal and veterinary food, drugs and supplements, and radiation-emitting products.
Food and Dietary Supplements
FDA regulates all foods distributed in the U.S. FDA regulates foods for safety, contamination, and proper labeling. All foods and supplements must contain approved ingredients, mandatory labeling, follow good manufacturing practices, and only make claims that are permitted for foods and nutritional supplements. Visit our pages on food and dietary supplements to learn more about the regulations that apply to both types of products.
At Capote Law Firm, we conduct label and ingredient reviews for all foods and dietary supplements in accordance with FDA regulations. We help clients with obtaining FDA approval for food additives.
Cosmetics
Cosmetics marketed in the U.S. must comply with the provisions of the Federal Food, Drug, and Cosmetic Act, Fair Packaging and Labeling Act, and other federal regulations. The U.S. FDA has issued regulations that pertain to permitted labeling, permitted ingredients, and claims that can be made on cosmetic labeling. It is the industry’s requirement to ensure that they are compliant with these regulations. Visit our cosmetics page to learn more about these regulations.
Is your product compliant? We can conduct ingredient and labeling reviews as well as analyses of any claims made on your website.
Pharmaceuticals, OTC & Homeopathic Drugs
One of the most highly regulated products on the market are pharmaceuticals and OTC drugs. Prescription drugs must undergo FDA approval through one of the various application processes, the most common being New Drug Applications (NDA). Over-the-counter drugs, also known as OTC, must comply with strict labeling, manufacturing, and ingredient regulations. These OTC drug regulations are referred to as OTC monographs. Similar to traditional allopathic OTC drugs, homeopathic drugs, whether prescription or OTC, must follow a homeopathic monograph. The monographs are published in the US Homeopathic Pharmacopoeia. Visit our OTC drug page for additional information on the regulations that apply to these products.
Are you complying with your OTC monograph? Do you need to file a New Drug Application? Capote Law Firm can prepare your orphan drug application, assist with implementing and conducting necessary product recalls, educate and train your staff on adverse event reporting compliance, prepare New Drug Applications and Abbreviated New Drug Applications. We will conduct annual internal audits of your facility so that if FDA comes knocking on your door, you can be assured that their inspection will run smoothly.
Is Your Business FDA Compliant?
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