August 27, 2015 by David Lennarz
Filed under: Food & Beverages |
On August 12, 2015, the U.S. Food and Drug Administration (FDA) issued a warning letter to Hampton Creek Foods, Inc. regarding its Just Mayo and Just Mayo Sriracha products. FDA considers the products to be misbranded, as they don’t meet FDA’s standard of identity for mayonnaise, which requires egg as an ingredient. ”The use of the term ‘mayo’ in the product names and the image of an egg may be misleading to consumers because it may lead them to believe that the products are the standardized food, mayonnaise,” FDA said. FDA also noted that the products contained “additional ingredients that are not permitted by the standard, such as modified food starch, pea protein, and beta-carotene.”
The warning letter comes nine months after Unilever filed a lawsuit against Hampton Creek for the same issue. Unilever claimed that Hampton Creek’s misbranding was deceiving customers and hurting sales of Unilever’s own mayonnaise products. Unilever withdrew the lawsuit a month later to allow Hampton Creek to properly re-label its products.
In the warning letter, FDA also took issue with “cholesterol free” claims made on the Just Mayo labels for three reasons:
- The Just Mayo product labels fail to disclose the level of total fat per serving in immediate proximity to the cholesterol claims, which is required by FDA due to the amount of fat in the products.
- The labels state “You’ll never find cholesterol in our products,” which is an unauthorized synonym for “cholesterol free.” Nutrient content claims may only be formatted in ways specifically defined in FDA regulations.
- The labels state “Your Heart Matters. When your heart is healthy, well, we’re happy. You’ll never find cholesterol in our products.” FDA said this implies that “these products can reduce the risk of heart disease due to the absence of cholesterol.” This is an implied health claim for which the products are not eligible to make due to their fat content.
Other labeling issues mentioned in the warning letter include an improperly formatted Nutrition Facts label and incorrect placement of the information panel. FDA gave Hampton Creek 15 days to respond to the warning letter with an outline of corrective actions.
Distributing misbranded products in the United States is a prohibited act. It is prudent to have your food label reviewed for regulatory compliance before marketing the product in the USA, as discovering issues post-marketing can yield time consuming and costly challenges as well as damage your brand. For example, Hampton Creek will likely need to redesign and reprint its label as well as re-label and rebrand its Just Mayo products as something other than mayonnaise.
Registrar Corp offers a Label and Ingredient Review Service through which our Regulatory Specialists will review all elements of your food label for FDA compliance, including standards of identity, claims, the Nutrition Facts label, and more. After the review, you’ll receive a detailed report (usually 40-50 pages), along with a print-ready graphic file that incorporates Registrar Corp’s changes.
For more information about U.S. FDA food labeling regulations and how Registrar Corp can help, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
To learn more about the five most common food labeling mistakes, click here.
August 24, 2015 by David Lennarz
Filed under: FDA News, Medical Devices |
Under the FDA Export Reform and Enhancement Act of 1996 (EREA), medical device companies can request export certificates from the U.S. Food and Drug Administration (FDA). The cost for an initial export certificate is $175. Subsequent copies of the certificate for use in the same country are offered for a reduced fee. On August 18, 2015, FDA increased the fee for subsequent medical device export certificates from $15 to $85 to account for increased costs of processing the certificates. This marks the second time FDA has increased the fee since the export certification program began in 1996.
Export certificates issued by FDA confirm in writing the regulatory or marketing status of a device being exported to the United States. EREA directs FDA to issue export certificates within 20 days of a request. Export certificates can be requested by logging into the FDA Unified Registration and Listing Systems (FURLS) and accessing the CECATS system. Manufacturers of medical devices who wish to obtain an Export Certificate must register their establishment(s) with FDA and list all devices.
Registrar Corp can assist medical device companies to obtain an Export Certificate to Foreign Government, which can be used to offer official assurance to foreign governments that a device is in compliance with U.S. regulations as well as to assure foreign buyers of a device’s quality. Registrar Corp can also assist with FDA registration and listing requirements. For more information about FDA export certificates or other FDA regulations for medical device companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist 24-hours a day at http://www.registrarcorp.com/livehelp.
August 18, 2015 by David Lennarz
Filed under: FDA News, Medical Devices |
The U.S. Food and Drug Administration (FDA) extended the Global Unique Device Identification Database (GUDID) submission compliance date for all labelers required to submit data to the GUDID by September 24, 2015 to October 24, 2015. The extension is the result of GUDID security vulnerability issues that have caused FDA to temporarily take the GUDID offline. Those affected by this extension include:
The one-month extension applies only to GUDID data submissions. Affected devices and their packaging must still be labeled with a Unique Device Identifier (UDI) by September 24, 2015. See Registrar Corp’s recently published guide to complying with FDA UDI requirements for more information.
Registrar Corp can help medical device labelers navigate FDA’s UDI and GUDID requirements. Our Regulatory Specialists can help device labelers determine the UDI compliance dates for their specific device, as well as submit their device data to the GUDID. To have Registrar Corp submit your data to FDA’s GUDID, contact us and we will send you a simple spreadsheet to complete and return to us.
For more information on FDA UDI and GUDID requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
August 13, 2015 by David Lennarz
Filed under: Drugs, FDA News |
The U.S. Food and Drug Administration (FDA) issued a warning letter to Duchesnay, Inc after a social media endorsement posted by U.S. celebrity Kim Kardashian was reported through FDA’s Bad Ad program. Kardashian published a lengthy post on her Instagram describing her successful experience with Duchesnay Inc’s product DICLEGIS, a prescription morning sickness medicine. “It’s been studied and there was no increased risk to the baby,” Kardashian said in her post.
FDA has strict regulations regarding the promotion of prescription drugs. Advertisements of drug products may only include information supported by strong evidence and must provide risk information in equal proportion to any benefit information. A referral to risk and safety information in another location, such as a website, does not fulfill this requirement.
“The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts,” FDA said in the warning letter. FDA said Kardashian’s post “suggest[s] that DICLEGIS is safer than has been demonstrated” and therefore misbrands the drug product. FDA requested that Duchesnay Inc either cease misbranding DICLEGIS (remove Kardashian’s endorsements) or stop distributing DICLEGIS in the United States, as distributing misbranded drugs in the U.S. is a prohibited act.
Registrar Corp is a U.S. FDA consulting firm that helps drug establishments navigate FDA regulations. Registrar Corp offers website and advertisement reviews through which Regulatory Specialists review the text of a drug establishment’s website and advertisements line by line and alert drug establishments of any non-compliance.
For questions or assistance with FDA regulations for advertising drug products or other FDA requirements for drug establishments, contact Registrar Corp at +1-757-224-0177. Live help is available 24-hours a day at http://www.registrarcorp.com/livehelp.
August 12, 2015 by David Lennarz
Filed under: Drugs, FDA News, Medical Devices |
In early August each year, the U.S. Food and Drug Administration (FDA) publishes various user fee rates for the upcoming fiscal year (October 1 to September 30). On August 3, 2015, FDA published its medical device and generic drug user fee rates for fiscal year (FY) 2016.
Medical Device User Fees
FDA has authority to collect medical device user fees under the Medical Device User Fee Amendments (MDUFA). With the exception of the establishment registration fee, medical device user fees are reduced for small businesses. The FY 2016 medical device user fee rates are as follows:
- Establishment Registration Fee : $3,845 (No Reduction for Small Businesses)
- Premarket Application (PMA, BLA, PDP): $261,388 / $65,347 for Small Businesses
- Premarket Notification (510(k)) : $5,228 / $ 2,614 for Small Businesses
- 513(g) request for classification information: $3,529 / $1,765 for Small Businesses
- Annual periodic reporting fee for class III device: $9,149 / $2,287 for Small Businesses
FDA’s FY 2016 medical device user fee rates show an increase from the FY 2015 rates. The most significant increase is found in the standard PMA fee, which increased by over ten thousand dollars.
To be considered for small business recognition for FY 2016, FDA must receive the request from a company, along with tax returns that have been verified by its country’s tax authority. Small business recognition must be requested annually, as it expires on September 30 of each year. Registrar Corp can help medical device companies determine whether or not they qualify as a small business, and if so, can help with the submission of the request. Registrar Corp can also register medical device companies with FDA and review a 510(k) for FDA compliance.
Generic Drug User Fees
Generic drug user fees are authorized under the Generic Drug User Fee Amendments of 2012 (GDUFA). FDA collects both application and facility fees from human generic drug manufacturers. There are no small business fee reductions for generic drugs. The FY 2016 fees are as follows:
- Abbreviated New Drug Application (ANDA): $76,030
- Prior Approval Supplement (PAS) to an ANDA: $38,020
- Drug Master File (DMF): $42,170
- Active Pharmaceutical Ingredient (API)—Domestic: $40,867
- API—Foreign: $55,867
- Finished Dosage Form (FDF)—Domestic: $243,905
- FDF—Foreign: $258,905
The FY 2016 application fees show a significant increase when compared to the FY 2015 rates. Both the ANDA and DMF application fees increased over fifteen thousand dollars. The facility fees are also slightly higher than FY 2015.
Registrar Corp can register drug facilities with FDA, as well as file new or update existing DMFs with FDA.
Registrar Corp helps medical device and generic drug manufacturers navigate and comply with U.S. FDA regulations. For questions about or assistance with U.S. FDA regulations, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at http://www.registrarcorp.com/livehelp.
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 18 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations
This blog was originally published as a press release.
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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