FDA

Determining whether your food or dietary supplement product is compliant with FDA and FTC regulations, as well as determining the best strategy from marketing can be a daunting task. Arrastia, Capote & Phang makes the process easier by taking the guess work out of the process.

FDA Registration

FDA requires facilities that manufacture, process, pack or store foods, drugs, and medical devices marketed in the U.S. file registrations with FDA. In addition, manufacturers of drugs and devices must list their products with FDA. These registrations and listings must be completed annually to stay in compliance with FDA regulations.

Under the Bioterrorism Act, foreign drug and device manufacturers are required to provide to the identity of known US importers. On importation statement must be filed with FDA identifying the registration numbers of various companies in the supply chain. We assist with filing Prior Notices and will work closely with your Customs broker to ensure compliance with Bioterrorism and Prior Notice. We will also act as U.S. agent for foreign facilities.

Foods & Dietary Supplement

FDA regulates all foods distributed in the U.S. FDA regulates foods for safety, contamination, and proper labeling. Arrastia, Capote & Phang 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 Arrastia, Capote & Phang advise you on the best course of action with each of these.

Cosmetics

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. 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 Drugs

One of the most highly regulated products on the market are pharmaceuticals and OTC drugs. Are you complying with your OTC monograph? Do you need to file an New Drug Application? Arrastia, Capote & Phang 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.

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. Arrastia & Capote 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.