Frequently Asked Questions

FDA food contact formulation (FCF) notification guidance plays an important role in determining regulatory status of components of a Food Contact Material.

Many industry professionals may be surprised to learn the FDA regulates food packaging. Food packaging is considered an indirect food additive. Determining the regulatory status of your food contact material can be challenging in part because of the number of options to choose from. Those options include:

1. Consulting 21 CFR 174-179 to see if the use of the component is an appropriately regulated indirect additive,OR
2. Consulting

Food canning establishment regulations are unique among food registration regulations. The FDA requires companies that produce certain shelf-stable, aseptically-sealed low-acid canned or acidified foods to obtain a Food Canning Establishment (FCE) registration. In addition, manufacturers must file documentation with U.S. FDA for each process used in the production of foods subject to these requirements. These submissions are known as a “Process Filing” and each is assigned a unique “Submission Identifier” (SID). This three part system forms the basis for the food canning establishment regulations.

Failing to register either yourself as an importer or your foreign manufacturer could lead to fines and penalties from the US FDA. Registration also demonstrates to distributors, import brokers, and insurers your professionalism and understanding of the regulations.

Avoid U.S. FDA refusals and detentions when shipping canned, bottled, jarred, and other shelf-stable foods in the United States by ensuring your food canning establishment is properly registered and your scheduled processes are properly filed. Please contact our Charlotte or Washington D.C. offices for a complimentary consultation on

FDA Certificate of Origin offer US companies an opportunity to demonstrate FDA approval and/or compliance. Facilities exporting products from the United States to a foreign market are often asked to supply an export “certificate” for products regulated by U.S. FDA. An Export Certificate is a document prepared by U.S. FDA containing information about a product’s regulatory or marketing status.

Contact us today for assistance selecting and completing the correct form.

U.S. FDA currently offers the following types of Export Certificates:

FDA Dietary Supplement Claims

**Please contact our Washington D.C. office if you require an urgent FDA dietary supplement review. Urgent reviews can typically be completed in one business day.**

FDA dietary supplement label review is an important step to complete prior to entering the market. A proper FDA dietary supplement label review will not only identify the rote regulatory requirements, such as statement of identity on the PDP, but also identify claims that pose a risk of reclassification. Reclassification results in a product marketed as a dietary supplement reclassified as a new unapproved drug. This new unapproved drug cannot be on the market.

What is a Dietary Supplement
A FDA dietary supplement label review begins by looking at whether the product meets the dietary supplement definition. The definition for dietary supplements is narrow and only includes ingested products. The question also asks whether the ingredients used are pharmaceutical, GRAS, or require a New Dietary Ingredient submission. Overlooking ingredient classification can be a common mistake in FDA dietary supplement label reviews.

Claims and Intended Use
There are three types of claims made on dietary supplement labels. Those are nutrient content, health/qualified health, and structure function claims. Each type of claim carries a specific definition and requirements that must be followed. A FDA dietary supplement label review identifies those criteria and ensure the claims made comport with the regulations. Skipping this step can lead to a Warning Letter for unapproved claims.

Claims also play an important role in assessing intended use. The intended use is a short-hand for reclassification. The label must objectively demonstrate an intended use through claims, images, and indirect claims to supplement a consumer’s health. Commonly regulatory professionals state a dietary supplement cannot make a claim to “treat/mitigate/cure” a disease or condition. This is an inverse way of saying those claims lead to reclassification as an unapproved new drug. This is perhaps one of the most important parts of a FDA dietary supplement label review.

Label and Labeling
A FDA dietary supplement label review should focus on all aspects of labeling. A common misconception is that FDA authority only extends to the product packaging. This is not true. The FDA exercises authority over “labeling” which has been judicially defined as any material that accompanies the product. This broad definition brings websites, social media, videos, radio programs/ad, and SEO into the scope of a FDA dietary supplement label review. A reviewer should include this material in the advice given.

Please contact our Charlotte or Washington D.C. office for more information on a FDA dietary supplement label review.

At FDA Atty, you have direct access to Marc Sanchez, senior counsel. Marc is available to discuss your case and answer any questions you may have.

Absolutely. We can advise you on what language you can and cannot use on packaging and marketing, so you can make smart decisions for your business.

We have over a decade of experience working with FDA legislation in the food, dietary supplement, beverage, cosmetic, medical device, tobacco, and drug industries.

No. Our practice is limited to proceedings regarding the FDA. This unique focus enables us to have highly specialized knowledge of this area.

No, our practice helps clients from coast to coast and around the world. We connect with clients by phone, e-mail, WhatsApp, and Skype no matter where they are.

Guidance on Self-Affirming GRAS and GRAS Notifications
FDA GRAS Petition Consultants:

Review of Guidance and Regulatory Requirements
FDA infant formula approval and notification is an important and detail process that must be completed before sales begin. Infant formula is a unique area of food regulation. The FDA rightfully views infants as a vulnerable population who rely on the formula as the sole source of nutrition. Parents place a great deal of trust in the product. To maintain that trust the FDA subjects infant formula to additional steps prior to entering the market.

Typically conventional foods (non juice, seafood, or low-acid/acidified canned food (LACF) are simply subject to registration with the FDA. Importers and manufacturers of infant formula not only must register, but also submit a 90-day notification and verification of the formula. A summary of those steps and the timing is provided below.

FDA Medical Device Classification

Verify The FDA Will Not Refuse to Accept Your 510K
When preparing a medical device 510k submission there are a number of important steps. The FDA medical device RTA checklist (a/k/a refuse to accept checklist) can often be an overlooked among the many moving pieces. Among the time-pressure to complete and submit the 510k in order to enter the market it is important to pause to ensure a submission will not be refused. A refused submission will only add to the delays.

The FDA published a Guidance Document (The Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s) that describes the criteria FDA uses in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. This Guidance Document provides the FDA medical device RTA checklist for traditional, abbreviated, and special 510ks.

The FDA medical device RTA checklist is not only a tool for industry but a new part of the medical device review. Beginning in 2013 the FDA implemented an administrative review. According to the Guidance Document this review must occur within 15 days of receiving the submission and prior to the substantive review. In the administrative review the FDA medical device RTA checklist is completed by the reviewer to determine if the submission is ready for substantive review or should be refused.

The FDA medical device RTA is dense with detail. The traditional 510k RTA checklist for example fills nearly 25-pages. It covers the basic topics of the 201(h) medical device definition to documentation on software or other performance data. The detailed RTA checlist can lead to a staggering number of refusals. It is important to make the FDA medical device RTA checklist a familiar part of the 510k drafting process as early as possible and every employee involved in the device acquainted with its requirements.

Please contact our Charlotte or Washington D.C. office for a complimentary consultation on FDA medical device regulation, including the FDA medical device RTA checklist.

Overview
FDA Prior Notice Imports is a relatively new requirement. Since December 12, 2003, FDA prior notice must be provided for all food for humans and animals that is imported or offered for import into the United States (Title 21 Code of Federal Regulations (21 CFR), Part 1, Subpart I). This is