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Experts debate pros, cons of mandatory product registry for dietary supplements

A veteran lawyer in Washington supports a requirement that companies register their dietary supplement product labels. The general idea—incorporated in legislation introduced in previous years on Capitol Hill—could lead to reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“I really believe that this movement has picked up speed this year,” said Scott Bass, an attorney who heads the Global Sciences team at Sidley Austin LLP.

Based on his discussions with myriad groups, the lawyer revealed, the idea’s “time has come.” He said it was possible to see “activity on this front as early as the fourth quarter” of 2018.

“And I don’t mean activity in the sense of the law passed,” Bass acknowledged, “but I mean serious legislative attention.”

In an interview during an annual symposium in California for the dietary supplement industry hosted in October by the Council for Responsible Nutrition(CRN), Bass laid out his support for a mandatory product registry.

“Unless we have a system where FDA can say, ‘We know what’s on the market in the list’ [of registered products] and then can easily find out what is not on that list and can easily enforce, we’re not going to be able to stem the rising tide of illegal products,” he asserted. “There really is no choice because FDA can never enforce against outliers unless they know what’s on the market legitimately.”

Added Bass: “Second, how can a company offer a product to consumers that is supposedly a health product and then say, ‘But I don’t want the government to know about it.’ It just makes no sense.”

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Product offerings grow for the anxiety, stress, mood and sleep category

Qualifying and quantifying the market for products that address anxiety, stress, mood and sleep is a little like trying to nail jelly to the wall or define “obscenity.” Regarding the latter, U.S. Supreme Court Justice Potter Stewart famously remarked in 1964 that “I know it when I see it” to describe his threshold test in Jacobellis v. Ohio. To some extent, this also applies to the market for products that address anxiety, stress, mood and sleep.

Products addressing anxiety, stress, mood and sleep are scattered all over the marketplace. No longer are innovation opportunities limited to over-the-counter (OTC) medications and dietary supplements.

GlobalData identified product innovation oriented around anxiety, stress, mood and sleep that spans nearly 30 different product categories. Product manufacturers are addressing these needs in categories as diverse as fruit, chocolate, yogurt and beer, to air fresheners, fabric conditioners, facial-care products and more.

Companies far and wide want a piece of the pie because the pie is big—and growing. GlobalData puts the global market for sleeping aids (classified as OTC health care products) at $US1.36 billion as of 2016. GlobalData expects this market will grow at a compound annual growth rate (CAGR) of just over 4.1 percent for the period from 2015 to 2020. GlobalData puts the U.S. market for sleeping aids at just under $375 million as of 2016, and projects that this market will expand at a CAGR of 3.5 percent for the period from 2015 to 2020.

But trying to measure a market like sleeping aids is not as easy as it used to be, as a growing amount of sleep-related product innovation is taking place outside of OTC health care products and supplements. It is not unusual today to see functional drinks, milk, tea, food products and even facial-care products promote enhanced sleep. Even within OTC medications, sleep aids have become a moving target as companies attempt to monetize interest in more natural and holistic formulations.

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