How much would you be willing to pay an attorney or paralegal to take care of all your FDA facility registration and product listing woes?  $500?  $750?  What about to have a reputable company serve as your US Agent, facilitating communications with FDA and making sure that your registrations and listings are up-to-date and compliant?   $1000?  Many companies are charging prices like these or higher for these services.  There seems to be a mindset in the industry that these services are hugely complex and take many hours, so they’re worth hundreds or … READ MORE

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The FDA regulatory consultants and affiliated attorneys at FDAImports.com recently achieved another success for one of their clients, obtaining removal from an FDA Import Alert for cosmetics.  The client, a Chinese cosmetic firm, was placed on FDA Import Alert 53-06, “Detention Without Physical Examination Of Cosmetics Containing Illegal Colors,” because a previous entry of product tested positive for an illegal color additive.   

The complicating factor in this case was that the product in question was a limited run so sending five additional clean shipments to … READ MORE

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Imagine a government official approaching you outside your business one afternoon.  The official demands that you empty your pockets. You refuse and ask why. “Because you appear to have contraband in your pockets.”  When you ask what evidence he has he answers, “I’m not sure . . . yet.” What would you do in this case?

This example seems outrageous to Americans and their love relationship with rights to privacy and against unlawful search and seizure. But it is similar to FDA’s every day “regulatory” actions against … READ MORE

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FDAImports.com recently assisted a Chinese company with removal from FDA Import Alert 53-17, “Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.”  This case is of particular interest, because it is a reminder that FDA makes mistakes too. In this case, FDA wrongly added the company to Import Alert even though the cosmetic presented no actual safety risk or violation.

FDA Import Alert 53-17 is a very common Import Alert for cosmetic products with China, Mexico, and Canada having the most companies listed.  Typically, an Import Alert listing comes … READ MORE

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FDA consulting firm, FDAImports.com, has won another substantial victory for a client on FDA Import Alert, this time for Import Alert 53-17, Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.  A Chinese company bringing in eye shadow to the United States found themselves on this import alert when their shipment was stopped at a U.S. port.  The charge stated that the product appeared to “contain a poisonous or deleterious substance which may render it injurious to health.”  The company … READ MORE

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Apparently, the smaller something is, the longer it takes to talk about.  This is the axiom currently employed by FDA, illustrated by the agency’s recently published guidance on nanomaterials in cosmetics and foods (5 years in the making).   While the European Union already requires companies to prove a product containing any nanotech materials is safe before the product can be sold to consumers, FDA has sat on the sidelines, forcing many industries to wait for some kind of guidance from FDA on how to proceed.

Slow to Speak

Back in 2007, … READ MORE

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FDAImports.com recently achieved another success, this time helping a client obtain removal from FDA Import Alert 53-17.  This particular Import Alert, “Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination,” affects over 50 International manufacturers and distributors of cosmetic products, especially products that come packaged in a kit or contain a variety of cosmetic products in one sellable unit.  In this case, a Chinese manufacturer was placed on the Import Alert Red List due to a labeling error that failed … READ MORE

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Cue the soundtrack from Jaws.

Earlier this month, the California Department of Toxic Substances Control (DTSC) issued a press release alleging that several nail polish manufacturers failed to declare the presence of potentially dangerous cosmetic ingredients, Toluene, Dibutyl Phthalate (DBP) and Formaldehyde. DTSC based its allegations on initial testing of 25 different cosmetic brands, chosen at random. The investigation also revealed that many of the brands failed to declare these ingredients even though their labeling explicitly stated they were free of these chemicals.

California authorities … READ MORE

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The FDA has “a total of about 50 full time equivalents to regulate a very large and growing industry,” said Michael Landa, Director of the Center for Food Safety and Applied Nutrition at the FDA in a statement made during a Senate hearing on the safety of cosmetics a few weeks ago. Landa went on to state that although the cosmetics industry is moving product in the billions of dollars, FDA has little more than a dozen employees that actually work in the trenches of … READ MORE

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FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap between budget and its ever-increasing responsibilities. As the agency attempts to launch new procedures and regulations in coming years, a primary source of funding will be from user fees, according to the justification set forth.  It’s not that FDA is unfamiliar with user fees … READ MORE

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Below are some of our favorite quotes and exchanges from last week’s Energy and Commerce Subcommittee on Health hearing, “Examining the Current State of Cosmetics.”  If you haven’t read our first blog about it please read that here.  What follows below are some of the more interesting quotes and exchanges from Michael Landa’s testimony portion of the hearing (our thoughts in italics):

 “FDA’s current authority is principally post-market…the pre-market authority is limited to color additives… we have the authority to ban ingredients … READ MORE

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