Weekly Roundup: FDA addresses adulterated dietary supplements sales, NPA opposes mandatory labeling bill

13 May 2022 --- This week in nutrition news, the US Food and Drug Administration (FDA) sent multiple warning letters to companies allegedly selling adulterated dietary supplements. The Natural Products Association (NPA) urged the industry to continue opposing the product labeling Bill Durbin-Braun by the FDA. Meanwhile, the European Specialist Sports Nutrition Alliance (ESSNA) launched its “Sustainability pledge: Lifting the Planet,” a significant step forward for industry's transition to sustainability.

In brief: Business news
The FDA issued warning letters to several companies for selling adulterated dietary supplements that contain new dietary ingredients (NDIs). The FDA has not received the required premarket NDI notifications in some cases and the products contained unsafe food additives in others. These products have the potential to harm consumers. Despite their lack of approval, several of the identified dietary supplements are classified as medications because they are intended for use in the cure, mitigation, treatment or prevention of disease. The companies include Advanced Nutritional Supplements, Exclusive Nutrition Products, Assault Labs, IronMag Labs, Killer Labz, Complete Nutrition, Max Muscle, New York Nutrition Company, Nutritional Sales and Customer Service and Steel Supplements. The companies mentioned were selling supplements that contain 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl and octopamine. The FDA has previously voiced concern about several of these substances and their negative impact on health.

Mystic Labs gummies are infused with 10 mg of hemp-derived Delta-9 THC and tested by an ISO-certified, third-party lab-testing facility.The Natural Products Association (NPA) has renewed its call for health and wellness advocates to petition congress to reject the Durbin-Braun proposal, which would require premarket approval for dietary supplements and weaken key Bioterrorism Act provisions. The NPA has been the major trade association working with congress to understand the Durbin-Braun bill’s consequences. NPA is urging all health and wellness advocates to write their representatives of congress, imploring them to oppose the Durbin-Braun bill via the NPA Action Center, which can be accessed on their website.

Evolva and Tovani Benzaquen Ingredients signed a distribution deal for Veri-te Resveratrol in Brazil. Evolva will get access to a lucrative portion of the Brazilian dietary supplement market due to the arrangement. This relationship is expected to generate at least CHF 1.5 million (US$1.49 million) in revenue over the next two and a half years. The Brazilian regulator (AgênciaMegaFood’s Extra Strength Sleep Melatonin Gummies include a 10 mg melatonin dosage per serving.Nacional de Vigilância Sanitária (ANVISA) has approved Evolva's Veri-te Resveratrol for sale in dietary supplements. Resveratrol is a polyphenolic compound found in low concentrations in plant sources such as grapes, peanuts and cranberries. Evolva’s Veri-te Resveratrol is suitable for nutritional supplements, functional beverages, cosmetics, pharmaceutical uses and animal health industries.

In brief: Launches and releases
Manufacturer and distributor of Delta-8 THC products, Mystic Labs unveiled its latest offering, Delta-9 THC Gummies, available at US retail locations nationwide and on its website. The Mystic Labs Delta-9 Gummies contain less than 0.3% Delta-9 THC by dry weight, legal under the 2018 Farm Bill. The gummies are available in Blue Raspberry Fusion, Savage Lime, Mixed Berry Blitz and Goji Berry Rush flavors. Each gummy contains 10 mg of hemp-derived Delta-9 THC. The product is positioned to enhance mood and relieve physical discomfort, among other claims.

Supplement provider MegaFood is expanding its sleep product range with the release of its new Extra Strength Sleep Melatonin Gummies. The gummies may help maintain a healthy sleep cycle as they deliver 10 mg of melatonin per serving in an orange blossom flavor. The Extra Strength Sleep Melatonin Gummies have added chamomile and lemon balm and no high-fructose corn syrup or gelatin in the formulation. The company points out that modern light sources, especially intense blue lights, can hinder the body’s natural melatonin production, leading to sleep deprivation.

Vital Proteins introduced a new brand campaign with chief creative officer Jennifer Aniston.Collagen brand Vital Proteins introduced a new brand campaign with chief creative officer (CCO) Jennifer Aniston, highlighting a new range of protein and collagen bars that she collaborated on and her other favorite items. The freshly released protein and collagen bars developed with Aniston include the Vital Protein and Jennifer Aniston Bars and are featured in the campaign. The bars will be available in three flavors: Peanut Butter Fudge, Cold Brew Coffee and Dark Chocolate Coconut – all under 200 calories each. Aniston-inspired ingredients and flavors such as the maca and maqui berry in the Peanut Butter Fudge, maca and cordyceps in the Cold Brew Coffee, and the reishi and lion’s mane in the Dark Chocolate Coconut. The bars have 14 g of protein, including 6 g of grass-fed, pasture-raised bovine collagen peptides. As CCO, Aniston played a crucial role in product development and advancement.

In brief: Announcements
A Kemin Industries division Kemin Equine is presenting a free, virtual event between May 25 to 26 to provide horse owners with information and nutrition resources to help their horses’ intestinal health and stress. The informative topics include leaky gut syndrome, the gut-brain axis, the equine microbiome, equine heat stress, feeding the laminitis horse and fecal water syndrome.

ESSNA has announced the launch of its “Sustainability pledge: Lifting the Planet,” a significant step forward in industry’s transition to sustainability. The program outlines the commitments of ESSNA members to a clean energy transition, circular packaging, effective waste management, ethical and sustainable ingredient sourcing and improved animal welfare practices. The Sustainability Pledge offers a comprehensive approach to environmental conservation and assists the local communities with which supply chains interact. The pledge aims to ensure that ingredients and raw materials can be traced back to sustainable sources transparently. It will also evaluate environmental and ethical credentials when choosing suppliers and choosing grass-fed whey products and organic farming methods. The pledge also includes investing in the development of plant-based products, the development of low-carbon packaging materials and minimizing product waste.

By Nicole Kerr