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Food that is bought, sold, and imported in the United States needs to have a label, ingredients that are permissible, food facility registration. Many companies do not have the expertise and skills in creating labels, so they hire a FDA consultant in order to keep within compliance of the regulations. There are five reasons why businesses should hire a consultant when they are dealing with food labeling under FDA regulations.

Compliance Process

When businesses create a new product for the public, they often do not understand what the details are in order to ensure their product is compliant with regulations. Using consultants will make it easier to get their product approved since they know all of the details in labeling.

Protecting the Company

By hiring a consultant, he or she is aware of the legality issues on how a new product needs to be labeled. The consultant will be preventing any potential lawsuits to the company by complying with the FDA regulatory guidelines for the labels. Consultants also are the ones to confirm that all procedures were followed if a consumer issues a compliant.

Staying in Compliance

When designing the label, the consultant is aware of all of the FDA laws and guidelines that are needed in order to be within compliance. The experts have the knowledge and expertise to word the label correctly while staying within the FDA guidelines. The consultant is also there to ensure that the business operates within the laws if an auditor of the FDA stops by.

Required Health Information

The experts will know what type of health claims may or may not be required and/or allowed on the packaging. They know where and when to put the nutrient information on the packaging as well. If a product contains allergens, the consulting firm needs to know how to word it on the label correctly in order to prevent injury to the customer.

Staying Informed

The FDA Consultant also keeps up to date with any new laws or guidelines that are released on a yearly basis. They know how to stay on top of the changes by going to seminars or taking self study courses. This is to ensure that the data on the labels remains within the guidelines of food labeling under FDA regulations.

As you may already know Import Alerts, or FDA’s automatic detention lists, can cause serious issues for your clients. Import Alerts are also known as detention without physical examination. An importer that finds itself or its products listed on FDA’s Import Alert lists faces the difficult task of proving to FDA’s officers that its products are in compliance. Proof can come in a variety of methods, but the common approach is through a private laboratory test. These tests can become quite costly when the importer must conduct them every importation.

What is the best course of action for these importers? How can your client get off this list in hopes of smoother, quicker importation of their products? There are a number of steps that need to be taken by these importers. This is a guideline to help them move in the right directions so that the product and/or company can be removed from the list.

The first step is to determine what was wrong with the product that resulted in the original Import Alert being issued. The type of issue will dictate the best manner and means of resolving the issue. The issue must be resolved, whether it is a labeling concern or an ingredient issue. The necessary steps to resolve the issue and ensure that it does not happen again must be documented, preferably in newly enacted company protocols that must be followed by employees.

Once the issue has been addressed and new procedures have been implemented and documented to ensure that the issue does not occur again then the importer must make entry. The product will be detained automatically by FDA and a hold designation will be issued. At this point it is up to you, as their customs broker, or an attorney retained by your client, to communicate with FDA and request that the product be allowed to be sent out for private laboratory testing. The testing facility must be approved by FDA and the manner and means of collecting samples must be in accordance with FDA standards. It is imperative that the correct laboratory be chosen. If the sampling method is done incorrectly, or the method of testing is not industry standard, then the product will not be released and another sample will have to be sent for testing.

After the first successful testing and release the importer must bring the product in four more times, for a total of five shipments. Each shipment must be tested and released. Finally, after five successful releases a petition may be submitted to FDA’s Division of Import Operations & Policy for consideration of removal. Once the petition is granted your client will be removed from Import Alert and detentions without physical examination will be a thing of the past.

Under the FDA food law known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 food facility registration is required to certain food facilities as well as providing FDA advanced notice of shipments carrying imported foods. Under the food laws domestic and food facilities that manufacture, process, pack or hold food for human or animal consumption must provide a FDA registration.

Foreign FDA registration is required in specific instances depending on what process of manufacturing is occurring in the particular facility. There are situations where the “primary” facility must register and there are situations where both the primary and secondary facilities must register.

Foods that are included and result in the requirement of food facility registration include dietary supplements, beverages, infant formulas, fruits and vegetables, dairy products, raw agricultural commodities, bakery goods, and many more. There are also a few exclusions as to what foods require FDA registration.

Foreign facilities must designate a US agent, who maintains a location in the US and is physically present in the US.

The purpose of the facility registration requirement is to provide FDA with the location and source of potential bioterrorism incident or an outbreak of food-borne illness as well as allow FDA to quickly notify any facilities that may be affected.

Failure to register is prohibited under US regulations. The federal government may bring a civil action, or it may bring a criminal action to prosecute persons who are responsible for the commission of a prohibited act. Furthermore, a foreign facility that fails to register will not be able to pass US Customs. The food product will be detained by FDA or Customs and Border Protection Services.

The repercussions of failing to register are widespread and can have a direct impact on your company’s ability to conduct business. Be sure your facility is registered before going to market.

Under the FDA laws a cosmetic is defined by its intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance. A drug on the other hand is defined a “(a) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and (b) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Do you know what your product is classified as?

Many distributors and manufacturers do not realize that a moisturizer is a cosmetic, but the moment an ingredient to is added for sun protection the product is now a combination product, cosmetic/over-the-counter drug. The implications of being a drug versus a cosmetic are widespread. For example, a cosmetic does not require FDA registration. However, an over-the-counter drug requires facility registration, labeling submission and what is known as a national drug code number provided by FDA.

The time involved in obtaining the necessary FDA registrations for an over-the-counter drug can be lengthy. This is why it is imperative that a distributor or manufacturer have their product reviewed before going to market, to ensure compliance with all applicable regulations.

Moreover, the statements made on a cosmetic’s labeling may subject it to classification as a drug. One example is claims regarding diseases. A product, regardless of how it is marketed, that claims to assist with a disease, say rosecea, will be considered a drug for purposes of FDA laws.

An attorney whose practice focuses on FDA matters and international trade can be a vital component. FDA attorneys are qualified to interpret regulations to ensure that the claims being made are compliant while still being able to market the product.