FDA: CBD still illegal in food, supplements
President Donald Trump has signed the Farm Bill into law, opening the door for research and commercial cultivation and development of hemp. With the law signed, the Food and Drug Administration reiterated its authority to regulate products containing cannabis or cannabis-derived ingredients.
FDA commissioner Scott Gottlieb said that even with the hemp provisions, Congress preserved the agency’s oversight of hemp.
“Additionally, it’s unlawful … to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” Gottlieb said. He said that this restriction exists because both CBD and THC are active ingredients in FDA-approved drugs and were subject to clinical investigations before they were marketed as foods or supplements.
“It’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug,” Gottlieb said.
Hydroxycut launches a new formula
Hydroxycut is introducing consumers to its new innovation — Hydroxycut Ultra Lean.
The product’s key ingredient combination and central component, CurcumaSlim, is a combination of Alpha Lipoic Acid, or ALA, and curcumin from the spice turmeric.
Iovate Health Sciences International, the makers of the weight loss product, created the ingredient by theorizing on various combinations that would work synergistically in a weight-loss supplement, the company said.
“I am one of many passionate people who stand behind Hydroxycut, and Hydroxycut Ultra Lean with CurcumaSlim represents our latest innovation—it is a truly effective product that is supported by two scientific studies,” Raza Bashir, vice president of scientific affairs, innovation and procurement, said. “The formula was made from scratch and has been in the works for nearly a decade. It’s a great option for those looking to kick-start their weight-loss journey.”
In two 16-week studies, men and women using these key ingredients lost an average of 12/56 lbs. and 4.84 lbs., respectively, while also following a calorie-reduced diet and walking program, the company said.
Further information on the product, including availability, can be found on the company’s website.
GSK, Pfizer to merge consumer health businesses
In a deal that could reshape the OTC market, GlaxoSmithKline and Pfizer will be entering into a joint venture, bringing together their consumer health businesses into a single entity. The combined sales of the two totaled $12.7 billion in 2017.
“We are pleased to announce this new joint venture for Pfizer Consumer Healthcare, delivering on our commitment to complete the strategic review for this business in 2018,” said Ian Read, chairman and CEO of Pfizer. “Pfizer and GSK have an excellent track record of creating successful collaborations, and we look forward to working together again to unlock the potential of our combined consumer healthcare businesses.”
The companies noted that the all-equity transaction — of which GSK will have a controlling 68% equity interest and Pfizer will have a 32% equity interest — would have a global OTC market share of 7.3%, leading the market in most key geographical areas, including the United States and China. Brands that would be included span such categories as pain relief, respiratory health, vitamin and mineral supplements, digestive health and oral health.
Brian McNamara, GSK Consumer Healthcare CEO, will be CEO of the joint venture, with GSK Consumer Healthcare CFO serving as CFO. GSK CEO Emma Walmsley will be chair. Pfizer will be able to appoint three directors to the joint venture’s nine-person board.
“Through the combination of GSK and Pfizer’s consumer healthcare businesses we will create substantial further value for shareholders,” Walmsley said. “At the same time, incremental cashflows and visibility of the intended separation will help support GSK’s future capital planning and further investment in our pharmaceuticals pipeline.
As part of the deal, GSK plans to separate the joint venture within three years of closing through a demerger of its equity interest, listing GSK Consumer Healthcare on the U.K. equity market. This will create two companies — one focused on consumer health, the other on pharmaceuticals and vaccines — and allow GSK to reduce the leverage in its pharmaceutical/vaccines company.
“With our future intention to separate, the transaction also presents a clear pathway forward for GSK to create a new global pharmaceuticals/vaccines company, with an R&D approach focused on science related to the immune system, use of genetics and advanced technologies, and a new world-leading consumer healthcare company,” Walmsley said. “Ultimately, our goal is to create two exceptional, U.K.-based global companies, with appropriate capital structures, that are each well positioned to deliver improving returns to shareholders and significant benefits to patients and consumers.”
GSK said it expects to see annual cost savings of 500 million pounds by 2022 for an expected total cash cost of £900 million and non-cash charges of 300 million pounds. The cash costs will paid for with roughly 1 billion pounds in proceeds from divestments, and one-quarter of the cost savings are expected to be reinvented into the business. GSK said it expects the transaction to be accretive to its total earnings in the second full year after closing, reflecting the impact of integration timing and costs, with expectations that it will be accretive to adjusted earnings and free cashflow in the first full year after closing. Pfizer expects to see $650 million in peak cost synergies, with the expectation that it will be slightly accretive in the first three years after the transaction closes.
The transaction is subject to GSK shareholder approval and the approval from certain antitrust authorities. GSK said it expects the deal to close in the second half of 2019, pending these approvals.