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On December 19, 2014, the U.S. Food and Drug Administration issued a final guidance document regarding children’s toys that contain laser beams.  In the guidance, FDA defines children’s laser toys and offers suggestions for both the manufacturing and labeling of laser toys.

FDA proposed a rule in June 2013 to define children’s laser toys and to require them to be manufactured within the IEC Class I emission limit, but the rule is still in the process of being finalized.  For now, the definition and suggestions in the guidance are solely FDA suggestion and are not supported by enforceable legal requirements.

Definition

FDA defines a “children’s toy laser product”  as “a product primarily used as a toy that is manufactured, designed, intended or promoted for novelty or visual entertainment use by children under 14 years of age.”  The agency excludes lasers that are used by children in a professional or academic setting from this definition.

Manufacturing

FDA believes that lasers have a higher chance of being used in an unsafe manner when in the hands of children.  The agency suggests that lasers used in children’s toys be kept within the FDA Class I or IEC Class I emission limits to minimize the risks they pose, such as retinal injury or skin burns, to those in range of the laser beam.  IEC Class I laser beams are safe for eyes, even when viewed directly for a long period of time.

Labeling

FDA recommends that laser toy labelers use IEC Class I designation labeling so that purchasers are aware of the minimal risk associated with the product.

While the previous suggestions for children’s laser toys are not enforced at this time, they may be in the near future.  Companies that wish to learn more about FDA’s regulations for laser products or need assistance with labeling a children’s laser toy should contact Registrar Corp.

About the Author: David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA.  Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.

         

All color additives must be approved by the U.S. Food and Drug Administration (FDA) before they are used in food, drugs, cosmetics, or medical devices that come in contact with a human or animal body for a significant period of time.  What many people don’t realize is that many of these color additives also require color batch certification, which is obtained by sending a sample of a batch of color to FDA for testing.

Highly synthetic color additives have a higher risk of contamination than other additives.  These additives, for which the U.S. name begins with “FD&C” or “D&C”, are subject to color batch certification.  Color batch certification must be obtained for every individual batch of color by sending a four ounce sample of each batch to FDA.  FDA will then test the sample to ensure any contaminants contained in the batch, such as lead or arsenic, do not exceed the amount allowed.

The fee for color batch certification is based on the weight of the batch.  For straight colors, the fee is $0.35 per pound with a minimum fee of $224. The fee is nonrefundable despite whether the color batch passes or fails the certification testing.

When purchasing a color additive for use in a product that will be sold in the U.S., the purchaser should check to see if the additive requires color batch certification.  If so, the purchaser should request proof of certification before purchasing the additive.  It’s important to use the U.S. name of a color additive when researching whether or not it requires color batch certification.  For example, a commonly used color additive is named “sunset yellow” in Europe.  “Sunset yellow” translates to “FD&C Yellow #6” in the U.S., a color which requires certification.  Similarly, the commonly used additive “Allura Red” is named “FD&C Red 40” and is another that requires certification.

If FDA certifies a color batch, the agency will send the manufacturer a certificate with a lot number.  If a product is shipped to the U.S. and it contains a color additive that requires certification, FDA may contact the owner or his U.S. Agent and ask for the lot number of the color batch.  If the contact cannot provide a valid lot number, the product may be deemed adulterated and may not be allowed into the United States.

FDA has published an import alert for companies with a history of shipping foods that contain illegal color additives, including those that are uncertified.  Any company on the import alert will have its products detained without physical examination at the U.S. border.  It’s important to comply with FDA’s color batch certification requirements to avoid the delays associated with being on an import alert.

For guidance on FDA’s requirements for a specific color additive, or to submit a sample for color batch certification, contact Registrar Corp.

About the Author:  David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA.  Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.

         

On December 9, 2014, the U.S. Food and Drug Administration (FDA) announced that the uniform compliance date for food labeling regulations issued in 2015 and 2016 will be January 1, 2018.  Changing the labels for an entire inventory of food products can take substantial time and money.  FDA’s labeling regulations are constantly evolving, so FDA coordinates the compliance dates for multiple changes to give the food industry adequate time to use its existing labels and develop new labels.  This way, the economic impact is less that it would be if the food industry was required to adapt its labeling to every individual change in regulations.

One labeling regulation to watch for in 2015 or 2016 is the Nutrition Facts Chart.  FDA proposed changes to the chart in February 2014.  If the proposed rules are finalized in the upcoming years, the food industry will need to change the chart on their labels by the uniform compliance date.

For assistance with reviewing a specific food or beverage label for FDA compliance or for more information about FDA’s requirements for food labels, contact Registrar Corp.

         

FDA Action Against Main Street Family Pharmacy



December 10, 2014 by David Lennarz

According to an FDA press announcement, Main Street Family Pharmacy, LLC plead guilty on December 4, 2014 to shipping drugs that were considered adulterated under the Food, Drug, and Cosmetic (FD&C) Act, which is a misdemeanor criminal violation.  Main Street had multiple regulatory compliance issues in the previous year.  In May and June 2013, the compounding pharmacy failed U.S. Food and Drug Administration (FDA) inspections due to insanitary conditions, deviations from current good manufacturing practices, and FDA’s findings of microbial contamination in some of the its drug products.  Main Street also announced a voluntary recall of its products compounded for sterile use in May 2013 after 26 adverse events were reported regarding its compounded methylprednisolone acetate (MPA) injections.

The United States District Court for the Western District of Tennessee ordered Main Street and its co-owner David A. Newbaker to pay a fine of $25,000 each, and Newbaker was sentenced to 12 months of probation.  The court also entered a civil consent decree of permanent injunction against Main Street, David A. Newbaker, and Christie R. Newbaker, the compounding pharmacy’s other co-owner.  Under the consent decree, Main Street and its owners are prohibited from manufacturing, holding, and distributing drug products until the company complies with the FD&C Act and other FDA regulations.

Non-compliance with FDA regulations can have detrimental consequences.  In order for a drug facility to succeed in the U.S., it must fully understand and comply with FDA’s requirements.  Registrar Corp can help navigate drug facilities through FDA regulations, as well as assist with certain requirements.   For questions regarding FDA drug regulations, contact Registrar Corp at +1-757-224-0177 or through the 24 hour live help service.

         

To get an abbreviated new drug application (ANDA) approved, an applicant must prove that its generic drug is bioequivalent to the brand name drug, known as the reference listed drug (RLD). To compare its generic drug with the RLD, the ANDA applicant must have access to a sufficient quantity of the RLD.

For some drugs, the U.S. Food and Drug Administration (FDA) requires that applicants submit a proposed risk management plan called a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of the drug outweigh its risks. FDA may also require elements to assure safe use (ETASU). Some RLD sponsors seek to hinder competition by using REMS and ETASU requirements as justification to refuse to sell their drug to generic drug manufacturers.

In December 2014, FDA published a draft guidance to help generic drug facilities obtain a letter from FDA stating that the agency “will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.” In order to obtain the letter, the ANDA applicant must prove that its bioequivalence (BE) protocols are comparable to those in the RLD’s REMS ETASU. If obtained, the letter does not require an RLD sponsor to sell its drug to the generic drug company, but rather eliminates REMS as a justification for not doing so.

An ANDA applicant that wishes to obtain such a letter should first make sure that the RLD for which it seeks to create a generic version is subject to REMS approval with ETASU. If so, the ANDA applicant should prepare one or more complete BE protocols that include necessary aspects of the RLD’s labeling and ETASU to conduct the BE study or studies in a safe manner. The draft protocols, along with all informed consent documents and informational materials to be distributed to the study investigators, pharmacists, and subjects, should be submitted to GenericDrugs@fda.hhs.gov.

After FDA reviews the documents, it will either suggest changes to the ANDA applicant or notify the applicant that the safety protections contained in the protocol(s) are determined to be comparable to those in the REMS ETASU. If the latter occurs and the ANDA applicant wants FDA to issue a letter to the RLD sponsor, the applicant should complete the authorization form contained in the guidance.

Registrar Corp assists companies with U.S. FDA drug regulations. Registrar Corp can help a drug facility register with FDA, list its products, review its product labels for FDA compliance, and more. If you have any questions about FDA requirements for drug facilities, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/LiveHelp.

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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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