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.
Capote Law Firm conducts label and ingredient reviews for all foods and dietary supplement in accordance with FDA regulations. We help clients with obtaining FDA approval for food additives. We also provide regulatory compliance with Nutrition Labeling and Education Act including health claims, nutrient content claims, formatting the labeling as well as advertising rules and regulations under FTC. Our staff will also consult on the use of new qualified health claims for conventional foods, ensuring compliance for medical foods and formulas, as well as packaging materials.
Dietary supplements are allowed to have structure/function claims, but not health claims. Can your company tell the difference between the two? Let us educated you and help a smooth transition for your dietary supplement from concept to market. We will also provide advertising guidance for your dietary supplement to ensure conformance with regards to testimonials, disclaimers, amount of evidence to support certain claims and various other FTC regulations. We will file your 30 Day Structure/Function Notification with FDA.
Have you received an FDA Warning Letter? Have you been audited by FDA? Let Capote Law Firm advise you on the best course of action with each of these.
Cosmetics marked in the US must comply with the provisions of the Federal Food, Drug and Cosmetic Act, Fair Packaging and Labeling Act and other federal regulations. US 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 cosmetic page to learn more about these regulations.
Is your product compliant? We can conduct ingredient and labeling review as well as an analysis 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 various application process, 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 Rx, OTC, and Homeopathic drug pages for additional information on the regulations that apply to these products.
Are you complying with your OTC monograph? Do you need to file an 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.
FDA regulates medical devices through a classification process. Each medical device falls into one of four categories, Class 1, 2, 3 or unclassified. Class 3 devices are those which are considered life-sustaining, Class 2 are those devices which require oversight, but not to the level of a life-sustaining device and Class 1 devices are those devices that require the least oversight. One example of a Class 1 medical device is a toothbrush. Unclassified devices are traditionally regulated similarly to Class 2 devices. Learn more about FDA's regulations and approval process for medical devices.
We can provide you with product development counseling, including coordinating with investigators, third party reviews, advertising requirements, and promotion of the device. We determine whether a product requires a pre-market notification and what the necessary registration and device listings may be. If a 510(k) application needs to be filed we will put together the necessary application material and file the application with FDA. Our staff works with the FDA, to the extent possible, addressing any and all concerns FDA may have with the device. We also work with scientists and regulatory personnel in the pre-market process.
All medical device facilities, including distributors, must have a quality system in place for tracing purposes as well as ensuring the product is developed in accordance with FDA regulations. Many facilities may be ISO certified, however FDA regulations require a few more documents to be included in your manual. Capote Law Firm can review, establish and find short comings with your quality system program as well as provide training and consulting for Medical Device Reporting. Our staff works efficiently to save you time and money.