PMTA Progress Update

Correction From July Issue

In one of the more bizarre experi-

ences of my 25-year career covering the convenience store industry, CStore Decisions has learned that the images sent to us for the Mountain Express Oil (MEX) article in our July issue featured CEO Turjo Wadud posing at a convenience store in Atlanta that was not his own or affiliated with MEX in any way.

CStore Decisions would never have published these images if we knew the store featured in the photos sent to us had no connection to Wadud or MEX. Upon learning this information, CStore Decisions pulled the article in its entirety from our digital issue and website and replaced the front cover image online in the digital issue. The story will remain removed from our website. This is an unprecedented situation. The true owners and operators of the store in question, Buckhead Shell (The Shoppe @ Buckhead), were disappointed to see their flagship store, which took over seven years to design and build, featured in a story highlighting someone else’s brand. We have been assured by Wadud’s public relations team at M-Squared PR — who randomly picked the store to do the photo shoot — that the move was not intended to take credit for another retail brand. Unfortunately, that was the perception from Buckhead Shell, and how the story may have appeared to readers.

Buckhead Shell commented, “We believe we were misled by Wadud and his team, who stated that they were doing an article 'for the industry.' Had they told any of us that they were planning to use our pictures on the cover page of CStore Decisions July 2021 issue, we would have stopped it immediately. We have spent a lot of time and energy building this store along with Clipper Petroleum, and we are deeply hurt with this turn of events.”

As editor-in chief, I know how hard it is to build a store that stands out in a competitive market, and I apologize for the misperception. I have expressed my apologies to the owners of Buckhead Shell and Clipper Petroleum. We have instituted safeguards to ensure this doesn't happen again. Buckhead Shell has graciously agreed to a profile feature in a future issue of CStore Decisions. — John Lofstock, editor-in-chief, CStore Decisions

Foxtrot Set for 50-Store National Expansion

Chicago-based Foxtrot is growing, with plans for 50 new stores across the country within the next two years. The brand, which already operates in Chicago, Dallas and Washington D.C., is expanding into New York City, Austin, Boston, Miami, Los Angeles and Houston, among other locations. New store formats will be twice as large as Foxtrot’s earliest models and feature expansive on-premises dining, enhanced cafe menus and in-store merchandising that anticipates trends within the consumer packaged goods landscape.

BP to Fully Acquire thorntons

BP announced an agreement to acquire full ownership of its Thorntons convenience stores joint venture. BP has agreed to purchase the majority share it does not already own in the business from ArcLight Capital Partners LLC. The deal is expected to close later this year following regulatory approvals. Following the transaction, BP will become a leading convenience operator in the Midwest, with 208 owned and operated locations across six states, including Kentucky, Illinois, Indiana, Ohio, Tennessee and Florida.

BP plans to retain and build on the Thorntons brand.

PMTA Progress Update

As the PMTA authorization deadline approaches, some 15,000 applications are still pending.

Thomas Briant • NATO

The Food and Drug Administration (FDA) is under a court order to review and either authorize or decline to authorize — by Sept. 9, 2021 — the marketing of new tobacco products for which manufacturers submitted Pre-Market Tobacco Applications (PMTAs). But with numerous applications waiting for review, FDA is unlikely to meet the deadline.

BACKGROUND

The federal law known as the Tobacco Control Act requires that before a tobacco product may be introduced into the U.S. market, the new product must undergo pre-market review by the FDA and receive marketing authorization from the agency.

If a product was already on the market as of Feb. 15, 2007, the product is grandfathered and does not need a pre-market application nor is FDA authorization required.

For every tobacco product that entered the market after Feb. 15, 2007, one of two applications will be required.

Either a Substantial Equivalence (SE) application that compares a new tobacco product to a similar one that is grandfathered or already has an SE approval order from the FDA, or a PMTA application is required for a new tobacco product that is not similar to a grandfathered product and was introduced into the market after Feb. 15, 2007. The deadline for filing these applications with the FDA was Sept. 9, 2020. Once a manufacturer files a SE or PMTA with the FDA, the agency follows a four-step review process.

First, the FDA conducts a preliminary review of an application to see if everything is complete. Next, the agency files the application if all the scientific studies, evidence and other data accompany the application. Third, the FDA undertakes its substantive review of the application, which can take up to one year or through the deadline of Sept. 9, 2021. Fourth, the FDA issues an order authorizing or not authorizing the application. To authorize an application, the FDA needs to determine that the product “is appropriate for the protection of the public health.”

FDA PROGRESS

On June 11, the FDA’s Office of Science held a live webinar titled “Deemed Product Review: A Conversation With the Center for Tobacco Products Office of Science.” The purpose of the webinar was to provide an

update on, and information about, the agency’s scientific review of pre-market tobacco applications for “deemed products,” which include cigars, pipe tobacco, hookah tobacco and electronic cigarette/ nicotine vapor products. The main focus of the webinar was on the application intake process, application review progress and allocation of agency review resources.

With the FDA required to finalize the review of all PMTAs by Sept. 9, 2021, and given the significant number of applications filed, the Office of Science stated that it is “striving to review as many applications as possible during this one-year period described in the court order that set the Sept. 9, (2020) application deadline” date, and that the FDA has the “discretion to defer enforcement action against particular products on a case-by-case basis.”

According to the FDA website, there were 269 PMTAs filed between October 2019 and July 2020. Then, in August of 2020, one month before the Sept. 9, 2020, filing deadline, some 10,184 PMTAs were filed. During the first nine days of September last year, another 4,567 PMTAs were filed. This means that almost 15,000 PMTAs have been filed and are pending with the agency.

The FDA has now published a list of filed and accepted PMTAs so that industry members know which products have had applications filed.

The complete set of PMTA metrics is available here: https://www.fda.gov/media/150179/download.

The FDA staff also said that “the likelihood of FDA reviewing all of the applications received by Sept. 9, 2021, is extremely low.” This means that if the application review process has not been concluded by Sept. 9, 2021, the FDA may use its discretion and extend the time to review PMTA applications on a case-by-case basis by deciding not to take enforcement action against manufacturers who timely filed PMTAs.

The following graphic is from the FDA website, which reports that for the “acceptance” stage in the four-step application review process, applications covering the listed number of products by category have been “accepted” by the agency:

In addition, the FDA reported on its website that it has issued “Refuse to Accept” letters to manufacturers for applications covering 59,229 electronic nicotine delivery system (ENDS) products (i.e., electronic cigarette/vapor products), five cigar products and 25 other kinds of tobacco products. Moreover, the FDA website shows that the agency issued “Refuse to File” letters to manufacturers for applications covering 3,628 ENDS products because necessary information was not included with the applications.

Finally, “Filing” letters have been sent to manufacturers for applications covering 138,377 ENDS products, informing the manufacturers that their applications will be entering the third or “substantive review” stage of the review process. If a SE or PMTA application was not filed for a product and an application needed to be filed by Sept. 9, 2020, then the product is illegally on the market and must be removed from the market.

The FDA continues to work through the large number of submitted applications; however, the agency will unlikely review all of the 15,000-plus applications by the Sept. 9, 2021, deadline. The agency may, however, at its discretion, extend the review time on a case-by-case basis and opt not to take any enforcement action.

Industry members should regularly check the FDA website for additional information on the status of PMTA applications.

Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.

heartwarming the world.

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Colonial Group, the parent company of Savannah, Ga.-based Enmarket convenience stores, is celebrating its 100th anniversary. The company’s longevity brating its 100th anniversary. The company’s longevity is a testament to its ability to recognize and adapt to is a testament to its ability to recognize and adapt to industry shifts across a century that has seen dynamic industry shifts across a century that has seen dynamic evolution in the convenience and petroleum industry. evolution in the convenience and petroleum industry.

Today, Enmarket is growing through new builds and acquisitions, while remodeling existing locations. It currently operates 129 locations in Georgia, South Carolina and North Carolina, sells Enmarket-branded fuel and features 23 in-bay automatic car washes and one express tunnel wash. The chain is fi nalizing the latest iteration of its prototype store design, expanding its The Eatery proprietary foodservice program across its fl eet of stores and investing in technology — from a loyalty program that launched in 2020 to frictionless checkout and electric vehicle (EV) charging. Brett Giesick, president of Enmarket, pointed to entrepreneurial vision and spirit as the keys behind the long-term success of Colonial Group and its Enmarket convenience store division.

To Colonial Group President and CEO Christian Demere, the company’s “real magic” has always been its people, which includes generations of other families that have worked for the company over the years. He takes seriously the mission of sustaining the company culture.

The company rebranded its convenience stores to “Enmark” in 1990, which stood for “energy marketing.” At the time, the existing stores featured a 200-square-foot kiosk model. Raymond Demere

“I believe our retail division is aligned with the culture of our parent company in that we take calculated risks, understand the need for ongoing investments of time and capital in our people and business,” Giesick said. “But most importantly, our mantra of ‘enriching life’ encourages us to do the right things for our team members and communities. What we do is for the longer-term betterment of all, not just shortterm results.”

That entrepreneurial vision is led by Colonial Group President and CEO Christian Demere, who represents the fourth generation of the family business.

“I feel humbled to have the privilege to be a part of such an incredible legacy,” said Christian Demere. When reflecting on the last 100 years, he noted his first thought is a deep sense of gratitude for the sacrifice and effort by not only the family, but also the dedicated employees that helped bring the company to where it stands today, which inspires in him a desire to put his all into growing the business and making it stronger.

“While I think I am naturally a very driven person, I think the 100-year legacy that I am now a part of, and ultimately responsible for, is a huge factor in my drive and passion,” he said.

HISTORY IN THE MAKING

Colonial Group’s roots date back to 1921. Founder Raymond Demere had returned from World War I and saw an opportunity to supply fuel for vehicles that were now powered by internal combustion engines as opposed to horses. He purchased a 55-gallon barrel of oil and founded Savannah’s first independent wholesale petroleum company, American Oil Co., on July 21, 1921. Two years later, he debuted his first American Oil Co. service station located on the corner of Drayton and Charlton in Savannah. Ten years after that, in

The third and fourth generations of family-owned Colonial Group leadership include Houstoun Demere, Savannah Yacht Center vice president; Robert Demere Jr., Colonial Group chairman of the board; and Christian Demere, Colonial Group president & CEO.

1933, Raymond Demere sold the name American Oil Co. to Standard Oil Co. of Indiana. He renamed the company Colonial Oil and moved it to a 21-acre parcel of land on the Savannah River, which remains the company headquarters today.

In 1926, he hired Charles Jarrell, who had been an office manager with the National Cash Register Co. Jarrell served as an officer and director of American Oil and Colonial Oil. When Raymond Demere passed away in 1953, Jarrell took the helm as president, with a goal of providing a sense of continuity, while carrying the company forward until the second generation of the family business obtained the experience needed to steer the company. That day came five years later in 1958, when the founder’s son, Robert Demere Sr., stepped into the role of president. Jarrell continued to serve the company, including as chairman of the board, until he retired in 1974.

Under Robert Demere Sr.’s leadership, the convenience store division, ‘Interstate Stations,’ was founded in 1964.

His son, the third generation of the family business, Robert Demere Jr., became president in 1986. The c-store chain, which at the time featured a 200-squarefoot kiosk model, was rebranded as Enmark in 1990, which stood for “energy marketing.” The rebrand included a prototype design that measured 3,500-4,000 square feet, featuring a new look and colors, in an effort to grow customer loyalty and position the chain as a leader in the gasoline retail market. From the 1990s to the 2000s, the brand changed with the times, transitioning away from a store model based on fuel and tobacco sales, to one that centered fresh food, healthy snacks and beverage offerings. With this new in-store strategy in place, the company’s leadership decided the time was right to update the brand to better align with its modern product offering. In 2015, the company rebranded its convenience stores to Enmarket, strategically keeping the word “Enmark” within the name to maintain brand awareness through the transition. “With the simple addition of two letters, we’ve included the word ‘market’ within our name, and that is more indicative of the type of stores we operate,” fourth-generation executive Houstoun Demere said at the time. Robert Demere Jr. also led the expansion of the Colonial Group beyond the c-stores, developing the business into one of America’s largest privately held companies with nine subsidiaries, which include Colonial Oil Industries Inc., Colonial Terminals Inc., Enmarket, Colonial Compliance Systems Inc., Colonial Energy Inc., Colonial Chemical Solutions Inc., Colonial Towing Inc., and Savannah Yacht Center and Aqua Smart Inc. Today, both of his sons, Christian and Houstoun, are continuing the company’s In 2015, the company rebranded its convenience stores to Enmarket, strategically keeping the word “Enmark” within the name to maintain legacy as fourth-generation leaders. Robert Demere Jr. remains involved with the combrand awareness through the transition. pany as chairman of the board of directors.

Robert Demere Sr.

Enmarket features Mooz frozen yogurt. It also offers grab-and-go items that are prepared fresh daily in the stores, including items such as breakfast biscuit sandwiches, salads, hot and cold sandwiches, and fruit cups.

Colonial Group opened the Savannah Yacht Center, a superyacht facility, which was incorporated as an entity of Colonial Group in 2016. Houstoun Demere became vice president of business development for the new startup, which opened in 2017. And in 2018, Christian Demere took the helm of Colonial Group as president and CEO.

EXPANDING ENMARKET

Industry veteran Brett Giesick joined Enmarket as president of the c-store division in 2017, after serving as chief retail officer of CEFCO convenience stores.

As Enmarket looks toward the future, it is growing through new-to-industry (NTI) builds as well as acquisitions, with a goal to build between five to 10 NTI stores per year.

To accommodate its growth, in 2019, Enmarket relocated the c-store division headquarters to the corner of Chatham Parkway and Highway 17 in Savannah, Ga., which includes two 23,000-square-foot buildings.

The chain’s latest prototype design measures just under 6,000 square feet and debuted in March 2020 at 4318 Ogeechee Road in Savannah, next door to the chain’s headquarters. The new site featured the company’s first Marketwash+ — an 80-foot tunnel wash.

At the time, Giesick noted, “We wanted a clean, modern design that accommodates the multiple roles of an Enmarket store — a fueling station, a deep convenience inventory, appealing and healthy prepared food options, and a modern, state-of-the-art car wash.”

The chain debuted two additional new-to-industry sites in 2020, around Chatham County, Ga. — a

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