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

Restless Americans Drive Double-Digit Gains in the Sleep Category

The number of consumers suffering from sleeping disorders continues to grow, and quality sleep is a major issue for many Americans. In fact 75.0% of surveyed consumers indicate they have trouble falling asleep. Many use OTC sleep aids, combination OTC pain relievers and sleep aids, natural and herbal remedies, or sleep devices, such as smart watches and sleep tracking apps which posted 50% sales growth to help them sleep. These market segments however, are growing at very different rates. For example, sales of OTC sleep aids like Unisom, ZzzQuil, and Simply Sleep expanded by 3.4%. In contrast, sales of natural and herbal sleep aids that contain melatonin or valerian rose 18.0%, and sleep devices grew over 50.0%, as per Kline’s Sleep Aids study. Continue reading

Many questions about CBD use for health and wellness – Kline report provides insights on consumers’ perceptions of CBD

There is much hype surrounding consumer-use cannabidiol (CBD) for health and wellness. There are hundreds of companies marketing tons of products; however, there is little consumer education or advertising, along with very nebulous claims, if any, about what the products will do for those who take them. There is even less information on dosage recommendations or clear labeling to help consumers understand how much CBD is actually contained in oral drops, tinctures, gummies, and other popular forms. In short, there’s lot of buzz surrounding this ingredient but little substance.Continue reading

Digestive System

Digestive health remains a strong growth category with increased consumer awareness and knowledge of probiotic benefits

There is growing awareness of the connection between probiotics and immunity. Studies show that bacteria found in probiotics assist in the maturation of immune cells and helps reduce undesirable bacteria in the body. More probiotics with immune-boosting claims are entering the category. Research continues to drive interest in probiotics and improved health. Continue reading