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"Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids," says Commissioner Scott Gottlieb.
Pharmavite will not follow NAD’s recommendation to discontinue claim its NatureMade Omega 3 Xtra Blend fish oil supplement offers “nearly 4x better absorption” than standard fish oil, but plans another clinical study supporting the statement.
Council of Better Business Bureau's industry self-regulation arm says UltraMax Health, after previously not responding to a request for evidence supporting Max Synapse online ad claims, stated in writing that it stopped using the claims and no longer is selling the product.
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“We want to show that the kratom industry is maturing, that people want to do the right thing,” says AKA Chairman Dave Herman. The standards go “well beyond” FDA's minimum GMP requirements for dietary supplements, AKA says.
Five-year reauthorization of USDA programs is controversial on numerous fronts because of its breadth. It includes programs from federal crop insurance to the Supplemental Nutrition Assistance Program, which accounts for 80% of the total spending. "As an industry, we need to be out there demonstrating support for the farm bill and why it’s so important for farmers to have that stability and consumers as well,” says Organic Trade Association executive Megan DeBates.
The surprising support of Senate majority leader Mitch McConnell is integral to the success of a provision in legislation to reauthorize USDA programs that would clarify hemp's removal from the federal list of controlled substances and ease limits on its production in the US. Meanwhile, Charlotte's Web Holdings' recent $100m IPO is a strong sign of investors' confidence in the future market for hemp products.
Marketers' websites and product labels stated other noncompliant claims that render their products unapproved new drugs, but references to opioid withdrawal treatment got FDA Commissioner Scott Gottlieb's attention. "Despite our warnings and previous regulatory and enforcement actions, we continue to find marketers actively selling kratom with unsubstantiated claims," Gottlieb says.
Health, Beauty And Wellness News: SIDI Protocol, Synthetic Labeling Survey, Recalls, Product Launches
Prebiotic aloe in a Veralixir shot; Carpe targets excessive sweating; Young Living offers subscriptions; Berry Sleepy puts $2.8m behind marketing; Jigsaw supports children's Mineral Power program; Trust Transparency survey on synthetic ingredient labeling; and Beaumont Bio homeopathics recalled.
Until CFSAN decides whether to engage in a rulemaking to amend FDA's supplement labeling regulation, it intends "to exercise enforcement discretion for those firms that choose to declare the quantitative amount of live microbial ingredients in the Supplement Facts label by CFUs in addition to weight," according to draft guidance.
Health, Beauty And Wellness News: HelloLife Recall, Nutraceutical Advisor And Foot Ease, Nutra Collagen Launches
HelloLife recalls products made at King Bio facility; Nutraceutical advisor is microbiome medicine pioneer; Foot Ease targets plantar fasciitis with nutrition; and Nutra Collagen available from Advanced Protein.
Other than making apparently false statements to FDA about no longer selling spiked supplements, operators of R Thomas Marketing, identified online as a social media consultancy, and S Hackett Marketing, which d/b/a "Just Enhance" and apparently sells a variety of consumer goods, made no contact with FDA or with DoJ, according to court order entered as a permanent injunction.
Health, Beauty And Wellness News: Keto At VSI, MegaFood In-Store Sales On Demand, Hälsa Oatgurt, Recalls
Vitamin Shoppe raises keto profile; in-store sales on demand from MegaFood office; Hain Celestial US sales slow Q4, full-year result; YGYI extends supplement, personal care, cosmetic lines; Hälsa Oatgurt drinkable yogurt launches; and FDA recalls.
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