FDA and Pharmacy Weekly Digest - September 2019 #2



Food/Dietary Supplements

FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food products. The FDA stated, “Beginning July 9, 2018, the FDA will receive and process new requests and updates to current listing information using the ELM for establishments exporting seafood and infant formula to China and establishments exporting collagen and gelatin products to the European Union. To ensure a successful transition to the electronic system, establishments that are currently listed for these products are strongly encouraged to submit a new request via the ELM. Establishments that previously submitted requests for inclusion on the dairy exports lists via the DLM will have continued access to these requests via the ELM.”

FDA Updates Submission Process for New Dietary Ingredient and Structure/Function Claims Notification and Food Ingredients – The FDA announced that as of Sept. 6, 2019, it will begin using a new submission system for NDIN and SFCN submissions. This is a part of the agency’s ongoing modernization efforts. The FDA also announced that it is modernizing the submission process for food ingredient and food packaging petitions or notifications.


FDA Warns Stem Cell producers – The FDA issued a press release and warning letter “for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk.”

FDA Releases Guidance on Chromatographic Analytical Methods – The final guidance “provides recommendations to sponsors, applicants, and contract research organizations regarding internal standard (IS) response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications, abbreviated new drug applications, biologics license applications, and supplements. Chromatographic analytical methods are commonly used to quantitate analyte concentrations in samples from nonclinical and clinical studies to support regulatory submissions.”

FDA Publishes Guidance on Seizure Treatment Drug Development – The final guidance “provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 2 years of age and older.”

Medical Devices

FDA Comments on Consent Decree Issued to Tennessee Facility – A federal court issued consent decrees to two companies prohibiting them from continuing to distribute drug, device and dietary supplement products. The allegation stated that “the defendants unlawfully distributed unapproved new drugs, adulterated and misbranded dietary supplements[,] and an adulterated and misbranded device.” FDA noted, “During inspections at the facility, FDA investigators found numerous violations of the CGMP requirements for dietary supplements, including failing to establish specifications to ensure that the products they receive for labeling are adequately identified and consistent with the purchase order and failing to establish and follow written procedures to review and investigate product complaints. Because the defendants failed to follow CGMP regulations, their dietary supplements are considered adulterated. Several of the defendants’ dietary supplements are also missing information on their labels required by law, rendering those products misbranded. Additionally, defendants distributed a device that is adulterated and misbranded. According to the complaint, despite previous warnings from the FDA and repeated promises to correct deficiencies, defendants continued to violate the law.”

FDA Issues De Novo Classification Guidance Documents – The FDA published three guidance documents related to de novo classification of medical devices. The documents address FDA’s performance goals, acceptance review and user fees.

FDA Publishes Guidance Documents on HDEs – The FDA issued two guidance documents related to the Humanitarian Device Exemption (HDE) Program. The first provides clarification to the industry and FDA staff about the FDA’s review practice related to the HDE program. The second focuses on submissions to the HDE Program and how such submissions should be prepared.


FDA Warns Vaping Company About Marketing Practices – The FDA issued a warning letter to an e-cigarette company “for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.”

CDC Reports on Lung Illness Associated With E-cigarette Usage – In coordination with the FDA and state and local health departments, the CDC is “investigating a multistate outbreak of severe pulmonary disease associated with e-cigarette product (devices, liquids, refill pods, and/or cartridges) use. This investigation is ongoing and has not identified a cause, but all reported cases have a history of using e-cigarette products.” The CDC also stated, “As of September 6, 2019, over 450 possible cases of lung illness associated with the use of e-cigarette products have been reported to CDC.”


FDA Issues Notice Related to 503B Bulks List – The FDA published a notice of “nine bulk drug substances that FDA has considered and is proposing not to include on the [503B bulks] list.” The list includes dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue and vecuronium bromide. The comment period closes on Nov. 4, 2019.

FDA Publishes Notice on 503A Bulks List – The FDA proposed 26 substances to be excluded from the 503A Bulks List. The excluded substances are: 7-keto dehydroepiandrosterone (DHEA), acetyl-L-carnitine (ALC), alanyl-L-glutamine, Aloe vera 200:1 freeze dried, artemisinin, astragalus extract 10:1, boswellia serrata extract (BWSE), cesium chloride, chondroitin sulfate, chrysin, curcumin, D-ribose, deoxy-D-glucose, diindolylmethane, domperidone, epigallocatechin gallate (EGCG), germanium sesquioxide, glycyrrhizin, kojic acid, nettle, nicotinamide adenine dinucleotide (NAD), nicotinamide adenine dinucleotide disodium reduced (NADH), rubidium chloride, sodium dichloroacetate, vanadyl sulfate, and vasoactive intestinal peptide (VIP).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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