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The U.S. Food and Drug Administration (FDA) recently started including reinspection fee information on emails sent to U.S. Agents of newly registered foreign food facilities. The new emails now broadcast the possibility of reinspection fees and prominently define what they entail. “Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)].For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. agent for the facility.”

Since 2003, foreign food and beverage companies selling to the U.S. have been required to list a U.S. Agent for FDA communications. The Bioterrorism Act of 2002 stated that the U.S. Agent’s role would be to facilitate communication between the FDA and the foreign facility. Since then thousands of foreign registrants have listed importers, customs brokers or even relatives living in the U.S. as their U.S. Agent for FDA communications. A company or individual may not even be aware that they were listed as a U.S. Agent. Are you listed as a U.S. Agent?

The U.S. Food Safety Modernization Act (FSMA) of 2011 expands the role of the U.S. Agent. Under FSMA, the U.S. Agent is responsible for FDA’s re-inspection costs which are billed per hour without limit. For the Fiscal Year 2014, the hourly rate for foreign food facility inspections is $302 (and $237 for domestic facilities) [1]. This can quickly result in charges of over $10,000 USD.

Individuals who feel they may be listed as a U.S. Agent and do not wish to be responsible for these fees should promptly opt out. It is only after the company has opted out of being a U.S. Agent that the FDA “will inform the facility that you notified us that you have not agreed to serve as the U.S. Agent for the facility and request that the facility amend its registration to designate as its U.S. Agent a person who has affirmatively agreed to serve as the facility’s U.S. Agent.” If you need assistance opting out of U.S. Agent responsibilities or are in need of a U.S. Agent for FDA communications, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

As a foreign facility’s U.S. Agent, Registrar Corp Regulatory Specialists help food facilities with their FDA registration and FDA communications. In addition, as part of Registrar Corp’s U.S. Agent service, Registrar Corp will dispatch a food safety expert trained in FDA inspections to the foreign facility to help the manufacturer prepare for an FDA inspection. This assistance is included in Registrar Corp’s U.S. Agent Service at no additional charge, other than travel and lodging expenses, if FDA has confirmed an actual date for an inspection.

With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company comply with U.S. FDA Regulations. For more information on U.S. FDA Food Facility Registration, U. S. Agent services, or any other FDA regulation, go to www.registrarcorp.com. About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.

[1] https://www.federalregister.gov/articles/2013/08/02/2013-18622/food-safety-modernization-act-domestic-and-foreign-facility-reinspection-recall-and-importer

         

(Registrar Corp recently issued a press release to address food and beverage labeling blunders as Coca-Cola’s case is argued before the Supreme Court. Coca-Cola has been accused of false advertising, but answers that its products comply with U.S. FDA label regulatory requirements.)

As a regulatory consulting firm specializing in U.S. Food and Drug Administration (FDA) regulations, Registrar Corp has been closely following the oral argument (No. 12761) recently made against the Coca-Cola Company before the U.S. Supreme Court. POM Wonderful, a pomegranate juice company, has brought suit against the Coca-Cola Company over the labeling of a blended fruit juice.

Coca-Cola’s subsidiary brand Minute Maid labeled one of their juice blends as a “Pomegranate Blueberry” juice blend. The ingredients in this beverage are approximately 0.3% pomegranate juice, but mainly consist of apple and grape juices. Competitor and pomegranate juice manufacturer, POM Wonderful is suing the Coca-Cola Company for false advertising. Coca-Cola is defending its labeling practices by responding that the juice label is compliant with U.S. FDA requirements, according to Court documents.

The FDA is the regulatory authority that sets and enforces the standards required for the labeling of foods and beverages sold in the United States. FDA’s labeling requirements are found in thousands of pages within the Code of Federal Regulations, as well as the Federal Register, EAFUS Database, GRAS Notices, Guidance Documents, Labeling Guides, and Warning Letters issued by U.S. FDA. All food and beverage manufacturers that sell dietary supplements, prepared food, and beverages within the United States must comply with these regulations.

POM Wonderful based their arguments on a law called the Lanham Act which allows for “businesses whose market is misappropriated by competitors that misrepresent the character of the goods they sell” to sue. The lawsuit claims that The Coca-Cola Company’s label misleads customers, fooling them into believing their Minute Maid Pomegranate Blueberry juice blend primarily consists of pomegranates and blueberries. The U.S. Supreme Court must make a decision on whether an FDA-compliant juice label may be actionable as false advertising under the Lanham Act.

“If Coca-Cola wins, the Court may add new powers to the FDA, by granting a ‘safe harbor’ to what otherwise might be deemed unfair competition, provided that FDA labeling rules were followed,” says Russell K. Statman, Executive Director at Registrar Corp.

For more information on U.S. FDA Labeling and Ingredient Regulations or any other U.S. FDA regulation, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp

         

Does FDA Classify Your Cosmetic as a Drug?



March 20, 2014 by David Lennarz

On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. The final rule requires specific labeling statements based on the results of these tests. As of December 17, 2013, all OTC sunscreens products were expected to comply with the revised OTC drug regulations.

Many countries define drugs and cosmetics differently from the United States. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, however, sunscreens are regulated as drugs. Cosmetics and drugs are subject to different regulatory requirements in the United States. Please note that some “personal care products” are drugs, or both cosmetics and drugs, under U.S. law.

The use of the term “sunscreen” or claims regarding sun protection on a product’s labeling may cause to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses such as a color additive or to protect the color of the product. I n order to avoid consumer misunderstanding, a cosmetic product that contains a sunscreen ingredient and uses the term “sunscreen” or similar sun protection claims on its labeling must qualify the term by describing the cosmetic benefit of the sunscreen ingredient. Accordingly, only those products that contain a sunscreen ingredient solely for a nontherapeutic, nonphysiological use, and which include a labeling statement that accurately describes that use, may be marketed as cosmetic products.

Improper labeling of your product can have severe repercussions as the labeling and composition requirements for cosmetics and drugs are very different. A mislabeled product may be deemed “misbranded” and denied entry into the United States.

If you are concerned about the classification of your product, the regulatory status of your ingredients, or the labeling and that accompany your product, Registrar Corp can assist. Registrar Corp’s Label & Ingredient Review service will research how all these regulations will impact your product and assist you in ensuring compliance as you export to the United States. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

         

Using Your Noodle to Understand Pasta Names



February 4, 2014 by David Lennarz

Ever walk down a store’s pasta aisle and wonder how the different pastas got their names? Well, as it turns out, pasta names are dictated by U.S. Code of Federal Regulations.

The United States Food and Drug Administration (FDA) establishes definitions of certain products, which are referred to as “standards of identity.” In order to use a name which is the subject of a standard of identity, the product must be produced in a manner that meets that standard. By the same token, a product that meets a standard of identity cannot be called by any other name, as FDA considers the name given by the standard of identity to be the “common or usual name” of the product. For example, only products that are mixes of milk and cream with between 10.5% and 18% milkfat may be called “Half-and-Half.”

FDA has standards of identity for many of the United States’ favorite pasta products based on the ingredients, size, and shape. Spaghetti, for example, must be “tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not more than 0.11 inch in diameter.” (21 CFR 139.110).

Some product names, such as “penne” or “angel hair,” are not specifically defined by FDA. Consumers think of angel hair as a thinner spaghetti noodle. If you look closely at some of those angel hair products in the store, you’ll find that many also bear the name “vermicelli product” on the front of the box. According to FDA’s standard for macaroni products, vermicelli is “cord-shaped (not tubular) and not more than 0.06 inch in diameter.” (21 CFR 139.110). Products that conform to the complete definition of vermicelli must bear this required name.

There are also a variety of enriched pasta products on the market. The term “enriched” refers to the thiamin, riboflavin, niacin, folic acid, and iron that FDA requires manufacturers to add to those products. As you can see, choosing the correct name for your product in accordance with FDA standards can be more complicated than many people expect.

Registrar Corp’s Label & Ingredient Review regulatory specialists review labeling for pasta and all other types of food products to help manufacturers avoid costly errors. To learn more about FDA’s standards of identity, food ingredients, or any other FDA regulation, contact Registrar Corp 24/7 at http://www.registrarcorp.com or call us at +1-757-224-0177. Or, tweet Registrar Corp (@RegistrarCorp) with specific questions.

About Registrar Corp:
Registrar Corp is a FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Drug Establishment Registrations and Drug label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.

         

The U.S. Food and Drug Administration (FDA) issued an extension for the comment period for its tentative determination regarding Partially Hydrogenated Oils, i.e. the primary dietary source of industrially-produced trans fatty acids, or trans fat. Due to the public health risks associated with eating PHOs, FDA requested comments and scientific data and information on PHOs. The original deadline for comments was January 7, 2014. According to a new notice in the Federal Register, the FDA has given a 60-day extension of the comment period to March 8, 2014. This was due to several comments that people and companies wanting to do experiments didn’t have enough time to collect sufficient data.

On November 8, 2013, the FDA released a notice in the Federal Register announcing the tentative determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for any use in food. If this preliminary determination is finalized, PHOs would be considered food additives, which are subject to premarket approval by FDA. Foods found to contain unapproved food additives are adulterated by law, and cannot be legally marketed in the U.S. This means that the burden of proving that PHOs are safe to eat would fall on the manufacturers of products containing PHOs.

The most common and frequently used PHOs have long been considered GRAS food ingredients by the industry. If FDA finalizes its determination that PHOs are not GRAS, the agency and food industry would have to establish a way to gradually phase out the use of PHOs in the U.S. food supply.

Submit a comment on the Tentative Determination Regarding Partially Hydrogenated Oils.

Learn more about FDA’s Trans Fat Notice

Registrar Corp will be providing additional information on U.S. FDA Labeling and Ingredient regulations and will alert industry when the final decision is published. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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