Join us for an overview of legal requirements when marketing child care products — to both the children who buy them, as well as to their parents or other caregivers. We will also examine unique considerations in science support for making claims for childrens products. The Committee has asked me to discuss the state of dietary supplements in the U.S., as we approach a decade-long landmark in the legislation governing these various products, the Dietary Supplement Health and Education Act of 1994. The Dietary Supplement Health and Education Act of 1994, DSHEA, amended the federal Food, Drug, and Cosmetic Act to establish a unique regulatory framework for these supplements, in an effort to strike a proper balance between providing consumers with access to dietary supplements they can choose to use to maintain and enhance their health, and giving FDA the regulatory power to act on supplements or supplements ingredients that pose safety problems, make false or misleading claims, or are otherwise adulterated or misbranded.
Under the Dietary Supplement Health and Education Act (DSHEA), a dietary supplement manufacturer or ingredient is responsible for making sure the product is safe before marketing. Once a product has reached the US market, the US Food and Drug Administration (FDA) is responsible for monitoring safety, and has the power to recall any unsafe food additive products. Claims that describe a dietary supplements role in supporting health are allowed on the labels of dietary supplements, provided that a manufacturer has proof that the claims are true and has informed the FDA within 30 days of marketing a product. This includes only products that fit the legal definition of dietary supplements under the U.S. Food and Drug Administration (FDA), with the exception of cannabis hemp products (CBD). Sales of herbal teas or herbal-based cosmetics are excluded.
Natural and Herbal Nutrition Supplements
NBJ provides estimates for the total annual sales of herbal supplements, along with sales across the three channels of distribution (mass-market; natural, health, and specialty; and direct-to-consumer) and sales by type of product (single-herb supplements versus combined formulations). From 2017-2019, direct-to-consumer sales of herbal supplements experienced the highest percent sales growth among the three NbJ market channels. In 2018 and 2019, the third highest healthcare priority was for non-specific uses (e.g., for overall health benefits), but total sales for mushroom products for energy and mood support more than doubled in 2020.
The immune health quaercetin supplement market, which accounts for the smallest share of quercetin supplement sales, also saw sales grow by 59.2% in 2020. According to SPINS, consumers on natural channels spent more on quercetin supplements markets in 2020 for allergies and respiratory health, followed by cardiovascular health and prostate health. According to SPINS, natural channel consumers in 2020 spent the most on quercetin supplements marketed for allergies and respiratory health, followed by cardiovascular health and prostate support. Another extolled the leap to herbalism of OTC giants like Warner-Lambert, SmithKlineBeecham, and American Home Products, with products like teas and herbs. A 1998 ad recommended Blood Tonic Syrup, which described itself as a Chinese-herbal (sic) liqueur made up of nine herbs and honey, promising to boost the production of all three types of blood cells, relieving anemia without any adverse effects.
Drug Store News claimed to reach 70,000 chain drug pharmacists with articles that frequently covered unproven medications, including one by a homeopath recommending unproven supplements such as borage oil and flax oil for menstrual cramping and menopausal complaints. Another commended such OTC giants as Warner-Lambert, SmithKlineBeecham, and American Home Products for jumping on the herbal bandwagon with such products as herbal teas and supplements. A 1998 advertisement recommended Blood Tonic Syrup, which it described as a Chinese herbal supplemen (sic) liquid composed of nine herbs and honey that promised to promote production of all 3 types of blood cells, naturally relieving anemia without side-effects. Food products constitutes the largest category in almost every nation. There has been a recent trend for food companies to promote toys and products bearing their brands logos to preschoolers and younger children to establish early, positive relationships with children, thereby increasing brand recognition and preferences. Youth-targeted marketing channels and techniques include TV ads, marketing to schools, product placement, childrens clubs, Internet, toys and products with brand logos, and promotions targeted at young people, such as cross-sells and tie-ins.
They also urge CFBAI to require that all products offered by brands in children-oriented ads comply with the Nutrition Facts Standard, and expand the scope to cover all types of marketing. They also call on federal lawmakers to prohibit unhealthy foods and beverages from being marketed to children as a tax-deductible business expense, and for local lawmakers to further limit marketing these products within their communities. Weary of CFBIs effectiveness more broadly, researchers have called upon the Federal Trade Commission to set voluntary guidelines for making sure that products for kids promote a healthy diet.
Maureen Enright directs the Child Food and Beverage Advertising Initiative (CFBAI), a voluntary pledge-based self-regulation initiative that sets standards for the commercialization of foods for children in the United States. The CFBAI is one of about a dozen voluntary self-regulation programs administered by BBBs national programs. In 2020, CFBAI, the food industrys voluntary self-regulation program, revised the qualified nutrition standards to lower sodium, and added a sugar restriction on products participating brands can advertise to children younger than 12. Other changes were expected to at that time require 40% of foods that were currently listed under CFBAIs products list be reformulated in order to continue to be eligible for child-directed advertising after January 1, 2020. Following publication of this draft guidance (July 2011), concerns were expressed by trade associations representing manufacturers of dietary supplements, as well as consumers, that the FDA appeared to attempt to shift enforcement burdens away from the agency to manufacturers, creating substantial bureaucratic barriers to innovation of new products and availability in the marketplace. I am president of the Council for Responsible Nutrition, a trade association representing what we call the mainstream base of the dietary supplement industry, products used by millions of Americans purchasing them in natural foods stores, on the mass market, in direct sales, and via mail-order. Cottage food products may be sold in Maryland direct to a consumer at a cottage food enterprises home, at a farmers market, a community event, through a person-to-person, through a mail-order vendor, or in retail grocery stores*. A cottage food business can apply to the MDH for a unique ID number which may be used on a cottage food products label. If a business decides to request and use the unique identification number on a cottage food products label as an alternative to the business address, the label shall include the identification number as well as the name and telephone number of the cottage food business.