What is FDA approval?


The phrase "FDA approval" is used very loosely when it comes to product compliance. The FDA only actually "approves" high risk medical devices, pharmaceutical drugs and food and color additives. A majority of products do not receive prior approval from FDA. With that said, importing products does add additional scrutiny as both CBP and FDA review products that enter the United States. Read more ...




Do all products go through the FDA approval process?


No, most products are not approved or reviewed by FDA before going on the market. For a majority of products regulated by the FDA, the responsibility for compliance is on the businesses marketing and selling the product(s) to ensure that the items are compliant with FDA regulations prior to marketing and sale. That makes it even more vital that your products are reviewed by an experienced person prior to be placed in the market.




My company just had an FDA inspection, what should I do now?


At the end of an FDA inspection, you should receive a Form 483. This will list all of the investigator's observations of non-compliance. It is important to respond to these observations as soon as possible as there is a 15 day deadline to respond in writing. Ensuring that the responses are thorough and if necessary, point out instances where you believe the inspector may have been incorrect is of utmost importance. Many clients attempt to respond on their own, only to find that they later receive a publicly posted warning letter after FDA finds their responses insufficient. Responding in a timely fashion and with thorough responses cannot be stressed enough to ensure your business does not suffer unnecessarily.




I want to begin selling a new FDA regulated product. How do I get started?


The most important aspect of ensuring compliance is ensuring that the product is properly classified. This means that you determine whether the product is a food, dietary supplement, cosmetic, medical device, tobacco product or drug. This is determined by the product's intended use. The intended use can be gathered from the nature of the product as well as any claims made in the marketing of the product. The next step is to ensure that you understand what is required by regulation before you begin printing labels, marketing and manufacturing the product.




My imported products were stopped at customs (Notice of Action was issued), what should I do now?


The FDA should have issued a Notice of Action if your shipment is being held or detained. This document will outline the non-compliance issues FDA has found. It is important to provide a thorough response as quickly as possible to provide the best chance of having the products released. Knowledge of FDA regulations and requirements is important to ensure that the written response answers each violation appropriately. Imported products and firms found to be in violation of FDA laws and regulations may also be subject to other enforcement actions including but not limited to seizure by Customs and Border Protection (CBP) or FDA, civil money penalties, bond actions, state embargo/stop sale, food importer debarment, and prosecution.




I want to begin importing products. What do I need to do?


The first thing to do is hire a customs broker who has knowledge and experience with CBP regulations and requirements. It is also important to ensure you have or you hire someone who has thorough knowledge of FDA regulations. Recently enforced regulations like the Foreign Supplier Verification Program for food products can be complex. Having someone with experience in these areas can help.




Do I really need an FDA attorney for compliance? What’s the worst that could happen?


You don't necessarily NEED an FDA attorney for compliance, but it sure is good to have one on your side. FDA attorneys not only have expertise and knowledge of FDA regulations, but can use the law in your defense if the agency takes action against you. Knowing the law is one thing, but knowing how to strategically apply it is another. Lawyers are trained to do this and do it skillfully. The worst case scenario depends on the issue, but here are some examples: - if you are importing, the FDA could hold and detain your products, require you to export back or destroy the products or place your company on a publicly published import alert. - if your fail to respond to 483 inspection observations in writing, the FDA will issue a warning letter which is publicly posted as well. This can escalate to injunctions, fines and criminal prosecution. FDA has the authority to issue injunctions, charge criminal fines, and prosecute criminally. There may also be civil liability from any injured consumers as well as repercussions from other federal and state agencies.




What is the timeframe for getting my products compliant?


This varies substantially depending on the product. If you only need a registration, it may be a week. If you require something like a medical device premarket approval it can take a year or more.




Is it really worth the money?


We get this question often, if not directly, by inference. The real question is, "How much do you value piece of mind?" Not only will the money you spend on the front end give you that piece of mind, but it will likely be substantially less than what you will spend and possibly lose in the case of FDA action against you. Example for Reference: DIetary Suppement Label and Ingredient Review Flat Fee: $1000 Estimated costs for dietary supplement compliance issue at import: Customs fees: $250 - $2,000 Attorney/consultant fees for Notice of Action Response: $3,500 - $8,000 Cost to export products back: $1,000 - $3,000 Cost for response to Import Alert: $5,000 Cost for Reconditioning: $5,000 - $10,000 Cost to review labeling and ingredients: $1,000 Cost to reprint all labeling: $3,000




My company recieved an FDA Warning Letter, now what?


The dreaded FDA Warning Letter can stop any company in its tracks. It may come as a surprise and the requirement to respond in 15 working days can be overwhelming. The most important thing to do, is to start working on a plan immediately. Begin compiling a list of the violations, addressing them and documenting a plan for addressing any that cannot be handled right away. Responding within the timeframe with actionable steps taken is key. Strategy in responses can be the difference between a Warning Letter closeout and continuing FDA action.





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FREQUENTLY ASKED QUESTIONS

Disclaimer: The FAQs are some of the questions that we frequently get asked in some (but not all) of the areas in which we practice. The questions and answers are not intended to be exhaustive and do not constitute legal advice for your particular question, issue or concern, nor do the questions and answers create any attorney-client relationship or duty on our part to assist you. The information, however, is intended to be helpful and to get you thinking in a more sophisticated manner about your legal issues and possibly will assist you to ask the right questions or determine whether you have a legal need. Moreover, we encourage you to contact us to dialog further on your issues or areas of interest.

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