AG Paxton Joins Letter to FDA Urging Stronger Protections Against Flavored E-Cigarettes

AUSTIN – Texas Attorney General Ken Paxton today joined a bipartisan coalition of 26 attorneys general urging the Food and Drug Administration (FDA) to strengthen its enforcement guidance on e-cigarettes. As it stands, the current guidance will not decrease e-cigarette use among underage citizens and creates loopholes that manufacturers can exploit.  

“The FDA has set forth guidelines that, while helpful, do not go far enough to protect our children from the heavily marketed allure of flavored electronic cigarettes,” said Attorney General Paxton. “It’s no secret that e-cigarette use amongst Texas youth has grown exponentially in the past few years. Our children need protections in place that prevent companies from luring them into tough-to-break nicotine addiction with disposable, often sweet-flavored alternatives to cigarettes that have not proved to be any safer than other tobacco products.”   

The FDA released guidance in January describing how the agency will prioritize e-cigarette enforcement resources, particularly against flavored, cartridge-based e-cigarettes, with the exception of tobacco or menthol flavored products. However, the guidance does not prioritize disposable products or refillable cartridge systems that are popular among youth. The bipartisan coalition also states that the FDA’s decision to permit menthol products is problematic, as manufacturers may mislabel their e-cigarette flavors, and flavored nicotine delivery systems continue to grow in popularity with the underage population.

FDA’s investigation is underway. CDC and states encourage Jimmy John’s consumers feeling ill to contact a healthcare provider.

FDA, along with CDC and state and local partners, are investigating an outbreak of 14 illnesses caused by E. coli O103 in Iowa, Illinois, Missouri, Texas and Utah. CDC is reporting that the epidemiologic evidence indicates that clover sprouts from Jimmy John’s restaurants are a likely source of this outbreak.  

The CDC is recommending that consumers who have recently eaten clover sprouts on a sandwich from Jimmy John’s restaurants and who are experiencing symptoms of E. coli infection, such as severe stomach cramps, diarrhea, fever, nausea, and/or vomiting, should contact their doctor and report their illness to their local health department. If consumers have a leftover sandwich with clover sprouts from Jimmy John’s, do not eat it and throw it away.

Generally, it is recommended that children, the elderly, pregnant women, and persons with weakened immune systems should avoid eating raw sprouts of any kind.

Jimmy John’s LLC reported that all of its restaurants stopped serving clover sprouts on February 24, 2020. At this time, clover sprouts should not be available at Jimmy John's.

FDA has activated a team to coordinate this outbreak investigation. This team is currently collecting records and initiating a traceback investigation to determine the source of the clover sprouts. Authorities are investigating whether implicated sprouts have been distributed elsewhere and will continue monitoring for additional illnesses.

Background

On February 21, 2020, the FDA issued a warning letter to Jimmy John’s Franchise LLC for engaging in a pattern of receiving and offering for sale adulterated fresh produce, specifically clover sprouts and cucumbers. On February 24, 2020, Jimmy John’s reported to FDA that they had removed sprouts from their restaurants.

The warning letter lays out evidence from five outbreaks, including recent outbreaks in the state of Iowa during November and December 2019, of human infections with Escherichia coli O103, a Shiga toxin producing Escherichia coli (STEC) linked to sprouts.

These 14 illnesses are new and are not associated with the outbreaks mentioned in the Jimmy Johns warning letter. FDA will continue its investigation and provide updates as more information becomes available.

FDA approves first generic of ProAir HFA

The U.S. Food and Drug Administration today approved the first
generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the
treatment or prevention of bronchospasm in patients four years of age
and older with reversible obstructive airway disease and the prevention
of exercise-induced bronchospasm in patients four years of age and
older.

“Today’s approval of the first generic drug product for one
of the most commonly used rescue inhalers in the U.S. is part of our
longstanding commitment to advance patient access to lower-cost,
high-quality generic drug products that are as safe and effective as
their brand name counterparts, and to expand opportunities to bring
generic copies of complex drugs to the market,” said FDA Commissioner
Stephen M. Hahn, M.D. “Metered dose inhalers like these are known as
complex generics, which are traditionally harder to copy because of
their complex formulation or mode of delivery. As a result, too many
complex drugs lack generic competition even after patents and
exclusivities no longer block generic approval. Supporting development
and approval of generic copies of these complex medicines so that these
products can get to patients has been a major focus of our efforts to
improve competition and access and to lower drug prices. Getting more
generic copies of complex drugs to the market is a key priority for how
we’ll help bring new savings to consumers.”

According to the National Heart, Lung, and Blood Institute, bronchospasms occur when the muscles surrounding the airways swell and tighten, squeezing the airways and making them smaller. Exercise and other physical activity can bring on symptoms in most people who have asthma and may occur either during or right after being active. Asthma causes recurring periods of wheezing (a whistling sound when breathing), chest tightness, shortness of breath and coughing. The coughing often worsens at night or early in the morning. Asthma affects people of all ages, but it most often starts during childhood. In the United States, more than 26 million people are known to have asthma, about 7 million of these people are children.

The most common side effects associated with Albuterol Sulfate
Inhalation Aerosol are headache, rapid heart rate (tachycardia), pain,
dizziness, sore throat (pharyngitis), rhinitis, chest pain,
palpitations, tremor and nervousness.

The FDA regularly takes steps to help guide industry through the
development process for generic drug products, including combination
products, such as metered dose inhalers, that consist of a drug and a
device. The development of generic combination products can be more
challenging than solid oral dosage forms, like tablets.

Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products.

In 2016, the FDA issued a revised draft product-specific guidance for proposed generic albuterol sulfate metered dose inhalers, including drug products referencing ProAir HFA. Among other things, the draft guidance provides bioequivalence recommendations.

The FDA requires sponsors to submit appropriate data and information
to demonstrate that complex generic drug-device combination products
meet the agency’s rigorous approval standards. These standards ensure
that quality generic drug products are as safe and effective as their
brand name counterparts.

In 2020, the FDA will continue to advance additional policies to promote generic competition for complex generic drug products. Among other steps, the agency intends to publish additional guidance documents to aid in the development of specific complex generic drug products. The FDA also plans to publish a series of guidances to address regulatory and scientific challenges that make it generally more difficult to develop complex generic drug products because of their complex formulation or mode of delivery. As part of this, the FDA intends to issue draft guidance with recommendations on establishing active ingredient sameness. In addition, the FDA is going to help advance the development of new analytical tools and in vitro tests that may provide additional accurate, sensitive and reproducible ways to support development of complex generic drugs. Better tools can reduce complex generic drug development time and cost and can inform regulatory decisions.

Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

The FDA granted approval of this generic albuterol sulfate inhalation aerosol to Perrigo Pharmaceutical Co.

The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines and
other biological products for human use, and medical devices. The agency
also is responsible for the safety and security of our nation’s food
supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.

FDA Investigated Multistate Outbreak of Salmonella Poona Linked to Cucumbers

The FDA, CDC, and state and local officials investigated a multistate outbreak of Salmonella
Poona linked to “slicer” cucumbers, supplied by Andrew and Williamson
Fresh Produce and grown in Baja, Mexico. This type of cucumber can also
be called “American” cucumbers.

According to the CDC, as of March 18, 2016, 907 people infected with the outbreak strains of Salmonella Poona have been reported from 40 states. The number of ill people reported from each state is as follows: Alabama (1), Alaska (21), Arizona (140), Arkansas (13), California (245), Colorado (21), Connecticut (1), Florida (1), Georgia(1), Hawaii (1), Idaho (27), Illinois (11), Indiana (5), Iowa (7), Kansas (2), Kentucky (1), Louisiana (5), Maryland (1), Minnesota (46), Missouri (15), Montana (16), Nebraska (8), Nevada (17), New Hampshire (1), New Mexico (37), New York (6), North Dakota (8), Ohio (3), Oklahoma (13), Oregon (23), Pennsylvania (3), South Carolina (10), South Dakota (3), Tennessee (1), Texas (51), Utah (62), Virginia (1), Washington (26), Wisconsin (46), and Wyoming (7).

Among 720 people with available information, 204 (28 percent)
reported being hospitalized. Among these people, illness onset dates
ranged from July 3, 2015 to February 29, 2016. Six deaths have been
reported from Arizona (1), California (3), Oklahoma (1), and Texas (1).
According to the California Department of Public Health, Salmonella
infection was considered to be a contributing factor in only one of the
three deaths in California. According to the CDC, the outbreak appears
to be over as of March 18, 2016.

Federal and state authorities identified clusters of people made ill
in separate geographic areas and worked to trace the distribution of the
food they ate back to a common supplier. The results of the traceback
investigation indicate that Andrew & Williamson Fresh Produce, of
San Diego, California, was a common supplier of cucumbers that were
eaten by the people in these illness clusters.

Several state health and agriculture departments collected and tested cucumbers from retail locations for the presence of Salmonella.
The Nevada Department of Health and Human Services, the Arizona
Department of Health Services, and the Montana Department of Public
Health and Human Services have isolated one of the outbreak strains of Salmonella
Poona from cucumbers collected from retail locations. Traceback showed
that these cucumbers were distributed by Andrew & Williamson Fresh
Produce. Additionally, the San Diego County Health and Human Services
Agency isolated one of the outbreak strains Salmonella Poona from cucumbers collected during a visit to the Andrew & Williamson Fresh Produce facility.

On September 3, 2015, FDA and the California Department of Public
Health (CDPH) briefed the management of Andrew & Williamson Fresh
Produce on the status of the investigation thus far.  Andrew &
Williamson has issued a voluntary recallExternal Link Disclaimer
of all cucumbers sold under its Limited Edition® label during the
period from August 1, 2015 through September 3, 2015.  This recall has
prompted additional voluntary recalls from firms that received Andrew
& Williamson Fresh Produce.

Andrew & Williamson Fresh Produce reported that the Limited
Edition cucumbers were distributed in the states of Alaska, Arkansas,
Arizona, California, Colorado, Florida, Idaho, Illinois, Kansas,
Kentucky, Louisiana, Mississippi, Minnesota, Montana, New Jersey, New
Mexico, Nevada, Oklahoma, Oregon, South Carolina, Texas, and Utah and
reached customers through retail, food service companies, wholesalers,
and brokers.

The company further reported that these cucumbers were shipped in a
black, green, yellow, and craft colored carton which reads “Limited
Edition Pole Grown Cucumbers.”  This variety is often referred to as a
“Slicer” or “American” cucumber.  It has a dark green color.  It
typically has a length of 7 to 10 inches and a diameter of 1.75 to 2.5
inches.  In retail it is typically sold in a bulk display without any
individual packaging or plastic wrapping.  In food service it is
typically served as part of a salad.

The FDA traceback investigation determined that the firm Rancho Don
Juanito de R.L. de C.V. located in Baja, Mexico was the primary source
of cucumbers shipped to Andrew & Williamson.

On September 14, 2015, the FDA issued an updated Import Alert to include cucumbers from Rancho Don Juanito de R.L. de C.V. located in Baja, Mexico. This action was based on the identification of Salmonella in cucumbers through import sampling of the farm’s cucumbers.

An FDA investigator completed an inspection of Rancho Don Juanito de
R.L. de C.V. on September 17, 2015. The FDA investigator was accompanied
by the Mexican authorities. Among the observations of the FDA
investigators were concerns with waste water management, equipment
design of the pre-wash area, and storage of packing material. The firm
corrected some issues during the inspection, including equipment design
of the pre-wash area. The firm also stopped cucumber harvests at the
implicated Rancho Don Juanito farm for the 2015 cucumber harvesting
season. The root cause of the contamination was not identified during
the FDA’s inspection.

The FDA added cucumbers from Rancho Don Juanito de R.L. de C.V. located in Baja, Mexico to a second Import Alert on September 23, 2015, based on the appearance that cucumbers from the firm appeared to have been prepared, packed, and held under insanitary conditions.  In order to overcome the appearance of a violation, Rancho Don Juanito de R.L. de C.V. should demonstrate that they have identified potential sources and routes of contamination and have taken steps to prevent future contamination before the company’s cucumbers can be removed from the Import Alert.

The number of reported illnesses did not return to the baseline
number for a produce outbreak for several months after the peak in
August and September. To prevent contaminated cucumbers from entering
the United States from other shippers in Mexico, FDA increased
surveillance on cucumbers imported from Mexico.  FDA also sampled other
commodities and also monitored subsequent cucumber recalls after the
initial recall and Import Alert to ensure that the cucumbers were not
contaminated with the outbreak strain of Salmonella.

Early in the outbreak, the FDA and state partners found the presence
of the outbreak strain of Salmonella in cucumbers from retail locations
and at ports of entry.  These cucumbers were subsequently recalled. The
results suggested a high level of contamination in these cucumbers,
which could increase the likelihood of cross-contamination of shipping
containers or other food contact surfaces. The FDA also conducted an
investigation involving review of records to determine if
cross-contamination within the distribution chain for the recalled
cucumbers could explain continued illnesses.  The results of the records
review investigation were inconclusive.

As part of the FDA’s risk-based and preventive approach to food
safety, in November, 2015, the FDA began a surveillance sampling program
that includes the collection and analysis of 1,600 cucumber samples
domestic and import samples from packing houses, manufacturers and
distributors within the United States during FY 2016.