Will Japan and Europe Switch Activity Impact the U.S. Market?

Embracing Rx-to-OTC Switch: Japan and Europe foster access to nonprescription medications, but will that have an impact on the United States market?

Recently, in Europe and Japan there have been increased Rx-to-OTC switch approvals and an environment fostering switch. The OTC men’s health category is growing in Europe, with the switch approval of Recordati’s Fortacin (lidocaine 7.5mg/prilocaine 2.5 mg) spray for premature ejaculation, via the centralized switch procedure through the European Medicines Agency. This drug marks the fifth medicine approved for switch through this centralized regulatory body, and it is expected to be launched throughout the EU on a nonprescription basis by early 2021. 

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Personalization Trend Enters the Vitamin Market

Personalization Trend Enters the Vitamin Market

American consumers are increasingly using personalized subscription services for clothing, beauty productsand meal kits—plus vitamins and nutritional supplements. In a category worth more than $10 billion—with as much as 75% of the population regularly consuming supplements—the sheer number of available products and brands can be confusing. That’s why personalization makes sense, as it helps consumers navigate a somewhat perplexing category.   Continue reading

Will the FDA’s OTC Monograph Reform Foster Innovation Including Increased Rx-to-OTC Switch Activity?

After years of the OTC industry and the Consumer Healthcare Products Association working with the FDA to pass long-overdue OTC monograph reform and regulatory modernization, long-sought-after reform is now a reality thanks to the CARES (Coronavirus Aid, Relief, and Economic Security) Act.  The act, which was passed by the U.S. Congress and signed into law by President Donald Trump on March 27, 2020, provides more than $110 million over five years for the FDA to significantly increase capacity and expertise in the Office of Nonprescription Drug Products. Continue reading

[Live Webinar] A 360-degree Look at CBD in Beauty, Health & Wellness, and Food & Beverages Industries

Across the United States, cannabidiol (CBD) has emerged as a prominent ingredient used in the healthcare, beauty, and food & beverages industries. Owing to the passage of the 2018 United States Farm Bill, which legalized the cultivation, sale, and distribution of hemp, consumer attitudes and usage of CBD enhanced over the past two years.

Considering cannabis-infused food and beverages, the overall market achieved strong double-digit growth of over 70% in 2019. Meanwhile, the market for CBD health and wellness products is forecast to reach nearly $2 billion by 2024 with steady growth every year. In the beauty industry, CBD remains the “it” ingredient that can be found in everything from skin care products to makeup and hair care.

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Nutritional Supplements During and After Pandemic Forecasts

 Nutritional Supplements Gain During Coronavirus Outbreak – But Can The Market Sustain a Recession? 

The COVID-19 pandemic has consumers scrambling to do more than kill germs on hands and surfaces. Amid the chaotic situation of out-of-stock shelves for cleaning products, hand soaps, and paper products, consumers are seeking ways to bolster their immune systems by eating more whole foods, increasing rest, and exercising. As a result, the nutritional supplements category is witnessing strong surge in demand as customers turn toward multivitamins, single-letter vitamins, and specialty supplementsFor one, Vitamin C products have seen a strong uptick in sales, as have other specialty supplements such as elderberryzincand echinacea.   

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CBD for Health and Wellness:

CBD Gets High Ratings, But Questions Remain

As part of our research on CBD for Health and Wellness: U.S. Market Analysis and Opportunities, Kline & Company has completed a second large-scale consumer attitudes and usage study on CBD. Adult U.S. consumers aged 21 and over make up the sample of nearly 700 consumers nationwide. Awareness is widespread and many consumers have tried CBD, but there are still numerous unanswered questions when it comes to usage.Continue reading

New FDA Approvals

Switch Activity Heating Up with New OTC Approvals

The U.S. FDA announced approval of three Rx-to-OTC switches on February 14, 2020. One is GlaxoSmithKline’s OTC version of its topical nonsteroidal anti-inflammatory (NSAID) pain reliever, Voltaren Gel (diclofenac sodium topical gel, 1%). This OTC medication will be indicated for temporary relief of joint pain and stiffness due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of the joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint. This medication has been sold without a prescription safely for years in Europe and marks the first topical analgesic with anti-inflammatory properties available without a prescription in the United States. It also offers another non-opiate option for those suffering from chronic arthritis pain.   Continue reading

U.S. House Judiciary Committee Votes for MORE, Federally Deschedules Cannabis

The Marijuana Opportunity, Reinvestment, and Expungement (MORE) Act passed in the House Judiciary Committee with a 24 to 10 vote on November 21, 2019. The MORE Act is historic because it:

• Removes or “deschedules” marijuana and cannabis from the federal Controlled Substances Act
• Allows states to enact their own cannabis regulations without federal interference
• Provides review and expungement of past cannabis convictions
• Provides reinvestments to communities adversely affected by the drug war Continue reading