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FDA

 

Scott Gottlieb kept a spotlight on oversight of the consumer health product market in his final week as US Food and Drug Administration commissioner, including another shot across the kratom sector's bow and more examples of electronic cigarette marketers crossing regulatory lines.

In the four days before Gottlieb wrapped up his two-year stint as FDA commissioner on April 5, the agency also announced the official start of its initiative to consider regulatory pathways to make cannabidiol, a derivative of hemp and cannabis plants, compliant as a dietary ingredient, and tan agreement with US Customs and Border Protection to maximize inspection and detection capabilities to prevent illegal products, including drug-spiked dietary supplements, entering the US through international mail facilities and ports of entry.

Gottlieb noted the weight consumer health has in the FDA's regulatory activities when he reviewed his work as commissioner in remarks to staff at the agency's Silver Spring, Md., headquarters on April 4. Oversight of the sector is so important to the FDA, he said, that his input wasn't going to be sufficient at a Capitol Hill hearing about overhauling the agency's OTC drugs monograph system.

 

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SCOTT GOTTLIEB SHINED A COMPARATIVELY BRIGHT SPOTLIGHT ON FDA'S CONSUMER HEALTH MARKET OVERSIGHT AS COMMISSIONER.

The longtime and influential director of the FDA Center for Drug Evaluation and Research, Janet Woodcock, has spearheaded the agency's work on updating and streamlining the monograph system. She asked to speak to members of Congress in a hearing about it.

"I testified before Congress 19 times in the past two years. The only major congressional hearing where I didn’t testify was the one hearing on OTC drug reform where Janet Woodcock told me I wasn’t allowed to attend because she wanted to be the agency’s witness," Gottlieb said.

"I don’t think she trusted me to do a good job," he added in a nod to Woodcock's fervor for making more self-care products available by improving the monograph process.

Gottlieb announced his resignation on March 5, weeks after he announced that the FDA will consider conducting rulemakings or ask Congress for legislation to strengthen its authority over vitamin, mineral and supplement (VMS) product manufacturing and marketing. His push for tightening oversight of the ENDS market as well as tobacco products could continue under his interim replacement, National Cancer Institute Director Ned Sharpless, who was appointed March 12. (Also see "Wellness Industry News: Acting FDA Commissioner Named, Thorne Test Line Grows, Nitrosigine In Revel Energy, More" - HBW Insight, 12 Mar, 2019.)

"He’s deeply public health minded, and a dedicated physician. I know he shares our mission," said Gottlieb in his remarks to staff.

High Heavy Metal Levels In Kratom Supplements

The FDA on April 3 published kratom product names with high levels of nickel and lead after working with dozens of firms to help reduce levels of heavy metals in their kratom products.

FDA warns two firms, identified as Undisputed Worldwide, of City of Industry, Calif., and EZ Fumes, of Bedford, Texas, about manufacturing and selling nicotine liquids with labeling or advertising that make the products misleadingly appear to be ingestible by imitating Rx prescription cough syrups.

The FDA announced in November it had found “disturbingly” high levels of metals in products containing the botanical while assessing 26 kratom products field agents obtained as a result of a multi-state salmonella outbreak, though at that time it did not identify the products or the amount of metal in them. (Also see "Salmonella In Kratom, Like Use Of The Herb, Exceeds FDA Expectations" - HBW Insight, 2 Jul, 2018.)

The FDA honed in on kratom under Gottlieb, who became commissioner in May 2017, as certain substances in the botanical – which the agency says is not compliant as a dietary ingredient – have been found to have opioid properties and hold the potential for abuse. The Drug Enforcement Agency has proposed scheduling kratom as a controlled substance. (Also see "DEA Takes Comments On Kratom, But Keeps Eye On Scheduling" - HBW Insight, 14 Oct, 2016.)

The kratom industry has argued the botanical was available in the US food supply before the Dietary Supplement Health and Education Act was passed in October 1994, allowing all dietary ingredients in use before then to remain available without notification to the FDA of reasonable expectations of safety for their intended uses. Kratom firms also contend the FDA in 2016 incorrectly stated and has continued to erroneously say the substances in kratom have opioid properties. (Also see "Kratom Advocates Urge Industry Compliance, FDA And DEA Compassion" - HBW Insight, 7 Mar, 2018.)

Still More Vaping Product Problems

Gottlieb also has had the FDA's crosshairs trained on e-cigarettes and liquid nicotine sold with those and other electric nicotine delivery systems (ENDS) as commissioner. On April 3, he acknowledged the products' potential for use in smoking cessation while also delivering more findings that cloud that outlook.

In a review of voluntary adverse event reports for ENDs submitted to the agency and to poison control centers, the FDA identified 35 reported cases of seizures following use of e-cigarettes between 2010 and early 2019, with an uptick starting in June 2018. Seizures or convulsions are known potential side effects of nicotine poisoning and have been reported in scientific literature from to intentional or accidental swallowing of nicotine-containing e-liquids, the FDA said. (Also see "Nicotine Poisoning Seizures Darken Cloud Around E-Cigarettes' NRT Potential " - HBW Insight, 3 Apr, 2019.)

A day later, the FDA announced warning letters to two firms, identified as Undisputed Worldwide, of City of Industry, Calif., and EZ Fumes, of Bedford, Texas, about manufacturing, selling and distributing nicotine liquids for e-cigarettes with labeling or advertising that make the products misleadingly appear to be ingestible by imitating Rx prescription cough syrups. The products had labeling with statements, representations and graphical elements imitating actual cough medications and a list of ingredients that mimic a Drug Facts label.

"By deliberately making or selling e-liquid products that look like prescription cough syrups, these companies are putting adults and children at risk of nicotine poisoning. The products are being designed in ways that make them falsely appear to be ingestible. These actions are egregious," Gottlieb said.

Nicotine addiction from use of the products by nonsmokers or continued nicotine dependency by former smokers have been a concern at the FDA since ENDS became available in the US, and stopping sales of the products to young people, driven largely by firms' marketing flavored nicotine, has been a priority for Gottlieb. (Also see "Smoking Cessation Indication For E-Cigarettes Could Fade Under Cloud Of Nicotine Packaged For Children" - HBW Insight, 1 May, 2018.)

On April 1, the FDA announced it has scheduled a May 15 public scientific workshop to discuss youth tobacco use and addiction and treatment strategies to support cessation. It conducted a public hearing in January to gain perspectives on the topic and has announced funding opportunities to support research on youth tobacco initiation, use and cessation; in March, it proposed ending its current compliance policy for flavored ENDS products, other than tobacco-, mint-, and menthol-flavored products, and to prioritize enforcement of products sold in ways that risk allowing access to minors.

Still, the FDA has backed its encouragement for research on ENDS' use in smoking cessation with draft guidances on clinical and nonclinical trials. (Also see "Wider Options In FDA's NRT Clinical Trial Guidance, Approval Path Still Narrow" - HBW Insight, 29 Mar, 2019.)

FDA, CBP Enhance Collaboration At IMFs

Another initiative Gottlieb pushed as commissioner was improving the agency's rate for intercepting violative products, notably products labeled as supplements but containing drugs, at the facilities around the country where international mail and other types of shipments reach the country.

The latest development on that front came April 4 with the FDA and US Customs and Border Protection signing an agreement to maximize inspection and detection capabilities in order to prevent illegal products entering the US through international mail facilities and ports of entry.

The FDA and CBP will expand how they share information to identify trends which can target future entries. This may include general data points on frequent countries of origin and specific products and volumes of packages at each location.

 

"Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate." – FDA Commissioner Scott Gottlieb

 

They also will coordinate for shared space as well as increased scientific presence at high-risk/high-volume IMF locations, helping to facilitate and support real-time entry decisions and increased data sharing. The agencies will enhance coordination around their efforts to identify violative packages and develop new targeting and enforcement strategies at ports of entry.

Nine IMFs currently operate in the US, with one location in Florida, Hawaii, Illinois, New Jersey, New York, Puerto Rico, US Virgin Islands and two in California. CBP provides security and facilitation operations at 328 ports of entry.

International mail shipment packages are valued at less than $200 and typically are intended for consumers rather than containing bulk amounts of goods intended for distributors or retailers. The tactic is used to avoid detection of products noncompliant with US regulations, including the FDA's for dietary supplements and drugs. (Also see "US International Mail Shipment Searches Reap More Spiked Supplements " - HBW Insight, 31 Jan, 2019.)

Most mail arrives in an IMF without advanced or specific identifying information. The FDA uses advanced screening technology to assess the packages' contents and to increase efficiency of the agency’s overall investigational capabilities.

In 2017, the FDA increased its number of investigators working with CBP officials at the nine IMFs from eight to 22 full-time employees, taking the number of packages the agency can open and screen from 10,000 a year to 40,000. Even with the increase, however, investigators were able to inspect less than 0.06% of the packages presumed to contain drug products.

“Thousands of illicit and dangerous products come from overseas each day, such as unapproved fentanyl products, counterfeit prescription drugs or fake over-the-counter products that look legitimate," stated Gottlieb in the FDA's announcement. "When bad actors try to circumvent the safety of our supply chains by breaking federal law, we’ll take all appropriate action necessary to ensure these potential risks do not harm the American public,” he added.

In fiscal year 2018, FDA staff posted at IMFs examined packages from more than 180 countries, and around 90% of the packages contained products that should not have been entering the country.

A six-month pilot program using ion mobility spectrometer portable screening technology, which law enforcement and security agencies use to test for explosives and illegal narcotics, found undeclared drug ingredients in 65% of tested products at two IMFs that were labeled as dietary supplements, the FDA reported in early 2018. The agency planned to refine its use of the device and eventually install it in all US IMFs so its staff can more quickly determine whether products contain undeclared drug ingredients. (Also see "Ion Spectrometer Improves FDA's Import Screening: Health And Wellness Industry News" - HBW Insight, 26 Mar, 2018.)

In June, facing pressure from Congress about the agency's success in intercepting shipments of fraudulent products, Gottlieb said the FDA did not have sufficient personnel to search all packages that reach international mail facilities. (Also see " US House Committee Requests Proof Of FDA Progress Seizing Opioids In International Mail" - HBW Insight, 13 Jun, 2018.)

He noted the FDA's responsibility to inspect international mail in his parting remarks to agency staff. "We sought and received historic new resources and authorities from Congress to advance our public health mission, increasing our footprint and authorities to act in the nine International Mail Facilities where our Office of Regulatory Affairs is on the front line of interdiction efforts to stop dangerous, counterfeit drugs and other violative products from entering the country and putting Americans at risk."

Congressional pressure continued in March as House appropriators questioned Gottlieb on whether the FDA was making progress in intercepting packages containing materials that are violative under agency regulations.

CBD Complexity Persists

Additionally, on April 2 the FDA once again acknowledged the complicated basis of the CBD oversight policy it has practiced under Gottlieb.

Realizing that sales of CBD-containing supplements and food products are soaring even though the substance is noncompliant as a dietary ingredient under FDA regulations, the agency, largely due to its limited resources, is exercising enforcement discretion and allowing sales of CBD supplements that are not marketed with disease claims by firms that are otherwise compliant with the agency's regulations and requirements.

Another complicating factor is that even without violative claims, CBD and other hemp- or cannabis-derived ingredients are excluded from dietary ingredient use because cannabis-derived CBD is approved for use in a drug and, before it was present in the US food supply, it and other cannabidiols were being studied for additional drug products. That timeline, despite their current prevalence in supplements and food products, makes their use as dietary ingredients noncompliant with FDA regulations.

The FDA is open, though, to establishing a regulatory pathway to allow the use of CBD derived from hemp and cannabis as a dietary ingredient. But on the same day announced a May 31 public hearing and a docket for public comment – FDA-2019-N-1482 – the FDA published warning letters to three firms marketing CBD and hemp supplements with claims for treating diseases including cancer and diabetes. (Also see "FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps" - HBW Insight, 2 Apr, 2019.)

The FDA's consideration of regulatory pathways for using hemp and CBD ingredients in supplements and food, which is led by an agency working group, started after some restraints on research, production and sales of hemp, which is a source of CBD, were eased in the latest farm bill, the re-authorization of US Department of Agriculture programs Congress passed in December. The bill did not eliminate the FDA's authority to regulate using hemp and CBD in supplements and food as well as in drugs and animal products. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)

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