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FDA Compliance

FDA Lawyer for help with Compliance & Registration of the FDA

Capote Law Firm’s FDA attorneys work diligently to identify potential FDA issues with compliance, mislabeling, misbranding, or alteration of a product. Our dedicated FDA lawyers work with industry specific professionals and keep them informed throughout every step of the FDA approval process. Capote Law provides practical advice to protect against future violations and delivers practical solutions that will ensure compliance. Our FDA attorneys work closely with support staff and clients, establishing achievable solutions to FDA regulatory concerns.

How to get FDA Approval

Companies looking to become FDA compliant rely on the FDA compliance attorneys at Capote Law Firm to resolve a wide-range of compliance and enforcement issues, including, but not limited to:

  • BioTerrorism Act Compliance
  • Medical Device Facility Registration & Product Listing
  • Dietary Supplement Statement of Nutritional Support
  • Label for foods and dietary supplements, drugs, cosmetics, and medical devices
  • Food Registration
  • Food Labeling
  • EPA Organic Labeling Regulations
  • OTC Drug Facility Registration
  • OTC Product Listing
  • Cosmetic Registration
  • Cosmetic Listing
  • Removal from Import Alert
  • USDA, EPA, FTC, CDC, CMS and CBP Compliance
  • FTC Advertising review
  • Responding to FDA Warning Letters
  • Inspectional FDA 483
  • Notices of FDA Action
  • Notices of Detention and Hearing for imported products

FDA Lawyer for Help with Compliance and Registration with the FDA

Our law firm’s FDA attorneys work diligently to ensure that you are aware of any potential FDA issues associated with mislabeling and misbranding compliance or alteration of a product.

Knowing that you have an FDA lawyer you can turn to who has industry specific experience allows you to stay informed through every step of the FDA approval process. Capote Law provides comprehensive and practical advice to protect against future violations while also delivering practical solutions that ensure compliance.

Our FDA attorneys are committed to working with you closely to support clients as well as staff in order to identify and achieve meaningful solutions to FDA regulatory concerns. Our FDA product law firm works one-on-one with manufacturers, processors, importers, and distributors throughout the United States and around the world.

Our FDA compliance firm represents clients in the food, OTC, prescription, cosmetics and medical device industries.

We bring an experienced team of attorneys and consultants to the table to guide corporations through the FDA regulations and rules as well as providing assistance with any other government agencies that may have jurisdiction over your products such as the U.S. Department of Agriculture, U.S. Customs and Border Protection, the Environmental Protection Agency, and the Consumer Product Safety Commission.

There are many different enforcement and compliance issues that any of these individuals may need assistance with. Our firm provides numerous different support for different types of products and concerns.

FDA Food Labeling:

Any company that does not comply with federal regulations associated with food labeling could be facing significant legal liability. Even established giants can fall or fail as a result of these challenges. Claims listed on food labels can characterize different aspects of the food including the nutrients in a food.

A claim that may be made earnestly may be interpreted differently by other individuals and may cause problems with the FDA. Although the FDA has established recommended daily intakes for certain nutrients, for example, it is important to have an experienced FDA labeling attorney review your product before it hits the shelves.

Consumers who purchase a food product with the belief that the labeling is accurate and fairly represents the food is common. Although the FDA does regulate some statements that are made on food products, others are not recommended.

•All labeling should be carefully reviewed by an FDA lawyer with food labeling experience prior to hitting the shelves.

Food Registration

How to register food product with FDAFDA registration is required under the U.S. Bio-Terrorism Act. This demands that all firms who deal with food for non-human or human consumption in the United States to have FDA registration. This is regardless of whether or not these facilities are foreign or domestic. Any facility engaged in holding, manufacturing, packing, or processing nourishment for consumption governs food contact substances and dietary supplements.

All domestic facilities are required to register as an FDA food facility as well as foreign facilities. FDA registration gives the government agency information about the distribution and origination of food products within the United States which allows for a quick response to real or potential threats to the food supply. FDA registration should lead to an FDA registration number for the business.

Having an experienced attorney to guide you through this process is strongly recommended for any business engaged in the process of food production.

EPA Organic Labeling Regulations

These days it can be significantly beneficial to be able to add organic materials and advertising statements on your food products. However, there are strict regulations governing this.

Our knowledgeable FDA food attorneys and EPA organic labeling lawyers are familiar with the regulatory compliance issues associated with beverages, dietary supplements, and food. It is essential to identify someone who has experience in this field so that you have appropriate advisement as you develop your products and market them.

It is important to understand all the rights and responsibilities entitled to and appropriate for individuals who are involved in the production of food labeled as organic.

Dietary Supplements Statement of Nutritional Support

register diet supplement with FDAWorking with an attorney to prepare labels or advise you about products requiring FTC or FDA-compliant labeling like nutraceuticals, dietary supplements or cosmetics is important. FDA compliance can be extremely comprehensive and confusing if you do not have a knowledgeable attorney who has assisted others in this field.

We can evaluate to determine whether or not your claims or the product name causes the product to meet the FTCA’s definition of drugs as well.

A dietary supplement is referred to as a product taken by mouth that is intended to supplement the diet and that contains one or more of the following dietary ingredients, a botanical or herb, an amino acid, a mineral, a vitamin or dietary substance used to supplement the diet by increasing dietary intake or an extract constituent concentrate metabolite of any combination of the ingredients above. The product must be labeled as a dietary supplement.

Regulations of Claims and Labeling Associated with Dietary Supplements and Other Products

Claims typically come in four different types including disease claims, function and structure claims, nutrient content claims and qualified health claims and health claims. Dietary supplements can make function or structure claims that will describe the product’s role in maintaining general wellbeing or a function or a structure of the body.

Labeling rules are extremely complicated and should be handled directly by an experienced attorney. In some situations, the Food and Drug Administration has regulations that overlap with the federal trade commission. This is why it is important to work with an attorney who can help you identify which apply to your individual situation.

OTC Drug Facility Regulation

All over the counter drugs are responsible for being officially registered with the FDA’s electronic submission portal. This means that the manufacturer is responsible for having a facility registration as well as the importer. This is important for all importers to recognize. At our law firm, we maneuver through the labeler code request, facility registration, and drug listing to ensure that your company is appropriately covered and in compliance with all FDA regulations.

OTC Product Listing

All processors, drug manufacturers. labelers, packers, re-labelers, and re-packers who offer drugs for distribution or for sale in the United States have to register their drug establishments with the FDA.

Every drug that is produced in commercial distribution must obtain a national drug code number. This may also be referred to as an NDC re-labeler code. The Capote Law Firm can help you register your drug establishment, can act as the U.S. agent for foreign drug manufacturers and can help you list your drug products as well.

Cosmetic Registration:

How to register cosmetic products with the FDAThe FDA uses a voluntary ingredient listing system and registration for those manufacturers, importers, and distributors that want to provide the FDA with details about the ingredients being used in their products and about their facility.

Capote Law Firm assists clients with obtaining the necessary registration details under the voluntary registration program.

Cosmetic Listing

The food and drug attorneys at the Capote Law Firm assist clients and provide advisement under the full range of regulatory compliance issues associated with cosmetics including advertising and labeling compliance issues within the U.S. and other international requirements, counseling about the potential product liability issues, advisement on the classification of a product as a drug or cosmetic based on product claims, defending against FTC advertising complaints and assisting with compliance issues, product recalls, record keeping, and governmental inspection practices.

Identifying a law firm with extensive experience in this field can be extremely important for growing your business.

Medical Device Facility Registration and Product Listing:

The marketing, development, and manufacturing of any medical device requires a complex understanding of the Food and Drug Administration’s regulatory process. Our experienced attorneys provide assistance with product clearance, approval, enforcement and compliance issues, post-market requirement and advertising concerns and product promotion.

Our attorneys understand the FDA regulatory processes associated with medical devices including pre-market approval applications, investigational device exemption applications, pre-market notification submissions, and humanitarian device exemptions. There are also extensive concerns that your company may have including:

  • how to register a medical device with the FDAInvestigator disqualifications
  • Pre-inspection audits
  • Assistance during an inspection
  • Import and export issues
  • Product recalls
  • Highly specialized medical device regulatory concerns

Compliance and Protection Under Various Laws:

Our attorneys also have extensive experience with dealing with a broad range of laws that govern production, advertising, and dissemination of your product. These include compliance with the laws listed below.

Bio-Terrorism Act Compliance

The Bio-Terrorism Act or the Public Health Security and Bio-Terrorism Preparedness and Response Act of 2002 was signed into law after the terrorist attacks in 2001. This amended the previous Food and Drug Cosmetic Act in order to give the FDA new inspection powers and enforcement capabilities.

There are many different issues associated with this including registration of food facilities, the authority of the FDA to institute debarment of food importers, and record keeping requirements for food facilities. It is important to identify an attorney who has experience handling the complex concerns of importing clients.

Removal from Import Alert:

FDA automatic detention list or FDA import alerts are used by the Food and Drug Administration to notify district offices about products or foreign manufacturing facilities that could be in violation of FDA regulations.

Many of these products and firms listed on such an import alert will be automatically detained by the FDA without having an inspection. This is why it is important to understand all of your rights and responsibilities and to have an attorney you can contact quickly in this situation.

USDA, EPA, FTC, CDC, CMS, and CBP Compliance:

Get help with FDA compliance issuesThere is a broad network of federal laws and regulations that govern the creation of, development, production, and marketing of food, cosmetic and medical devices across the United States. In many cases, these various regulations will overlap although they might have slightly different requirements.

It can be extremely confusing for a business owner to attempt to determine all the ways in which they must fall under compliance with these rules. Consulting with an attorney who is capable of digesting all this information and developing a strategy as a result is strongly recommended.

FTC Advertising Review:

Promoting services and products means complying with state, federal and FTC regulations. Non-compliance could lead to enforceable professional bans or substantial fines. The Capote law firm helps clients avoid these FTC fines and assist when a party is under investigation for deceptive and unfair marketing.

One of the most common ways that this can emerge has to do with an FTC advertising review when problems have been raised or when you wish to have a product and its marketing campaign analyzed in full before it moves forward.

Responding to FDA Warning Letters:

How to respond to FDA warning letterHow a company chooses to respond to an FDA warning letter can be important for how an FDA investigation or further actions unfold. Obtaining an attorney who has experience in this field as soon as possible can help to identify all possible risks and to develop a strategy to appropriately handle and respond to the FDA warning letter.

Inspectional FDA Form 483:

Prompt and skilled defense may be important for any FDA enforcement issues. An FDA inspection is typically the first in a series of events that could have significant consequences for your company.

A Form 483 report of inspectional observations means that your company needs to issue a response to those observations within 15 business days in the event that your company wants the FDA to consider these responses when deciding whether or not to move forward with a warning letter. 

Notices of FDA Action

The Food and Drug Administration works in conjunction with the U.S. Customs and Border protection to ensure that all products are in complete compliance with all necessary laws and regulations before they are exported or imported to or from the United States.

In certain situations, customs or the FDA can deny entry for a product if they believe that it fails to meet the strict requirements. In the event that those that are believed to be non-compliant are detained for further examination, the FDA District Office will then issue a notice of FDA action. This will explain the details of the violation and gives the owner or the consignee of the product a chance to respond and to provide evidence. Having an attorney in this situation is strongly recommended.

FDA Notices of Detention and Hearing for Imported Products

lawyer for FDA hearingObtaining an FDA import release for a detained shipment could lead to delays of weeks or months. The FDA has the jurisdictional right to inspect, examine, review or sample documentation associated with an imported product. It is critical to resolve your import detention concern while it is still in the detention stage.

If the FDA moves forward with an FDA import refusal notice this will be much more difficult to handle. The FDA may not reverse or resend their refusal later even in the event that the FDA refusal is wrong. Consulting with an experienced attorney in this situation can be extremely beneficial for identifying ways to bring that item into compliance and get an FDA import release.

FDA Compliance Issues:

It is important to be aware of all necessary compliance issues well in advance. However, you may also wish to consult with an experienced FDA lawyer if there are issues when you are not in compliance with state or federal regulations.

An attorney can conduct an audit of your existing practices and provide recommended strategies for resolving issues when not in compliance. In the event that you have already been flagged with a notice of inspection or a warning letter, it is important to respond as professionally and promptly as possible and to evaluate potential strategies for becoming in compliance quickly.

This could be critical for stopping a minor issue from escalating any further. It can also be important for minimizing your risks in the long run.

FDA Export Certificates and Free Sales Certificates:

Depending on your business practices and the products involved, you may also need assistance obtaining FDA export certificates or free sales certificates. Attempting to manage this on your own could lead to minor mistakes that could cost your business significantly or delays and other problems down the road.

Identifying an attorney as soon as possible in the event that you need a free sales or FDA export certificate is strongly recommended.

About the FDA Red List and the FDA Black List

How to get off FDA Red ListIf a company is placed on the import alert list it means that the FDA is sending a warning to importers around the world regarding the company’s safety concerns and products. It can lead to significant costs as the FDA may be able to automatically detain these products at the border referred to a detention without physical examination.

It can become extremely expensive for importers. In the event that the FDA refuses a shipment based on the importer taking no action about an automatic detention, these shipments may also be destroyed or exported. There is a comprehensive import alert page that allows individuals to identify materials about someone on the FDA blacklist including their country and their company name.

You cannot be removed from the FDA blacklist until sufficient evidence is provided identifying that the merchandise meets FDA compliance. The exact methods used for being removed from the import alert list are associated with the reasons why a company was put there to begin with.

A petition needs to be filed directly with the FDA requesting removal from the list and further details have to be provided. It has to be persuasive and convincing that the problem has been completely rectified.

Consulting with an attorney in this situation is strongly recommended. A red list refers to products, firms or countries being subject to detention without physical examination under the import alert.

When a product or a firm is in violation and meets the criteria outlined in an import alert, it will automatically be added to the red list or taken off the green list. This includes situations in which a foreign firm had a violated inspection by the FDA, the FDA has sampled the product and it contains illegal food additives or illegal colors, the product contains pesticides that do not meet tolerance levels, or the FDA sampled the product and tested in violation for a pathogen.

If the product is an unapproved new drug or has not provided sufficient evidence to support, adding them to the green list, this can also lead to them being added to the red list. Identifying an attorney is strongly recommended to avoid these problems as well as in situations in which your company or product has already been named on the red list.    

Lawyer for help with FDA approvalCapote Law FDA product law firm works one-on-one with manufacturers, importers, processors and distributors through the United States and internationally. Our FDA compliance firm represents clients in the food, prescription, OTC drug, cosmetics, and medical device industries. Our experienced team of attorneys and consultants guide corporations through FDA rules and regulations and any other government agencies that may have jurisdiction over FDA regulated products, such as the U.S. Customs and Border Protection (CBP), U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Consumer Product Safety Commission (CPSC), and many other abroad agencies.

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