Regulatory

Nutritional Outlook asked a handful of supplement industry stakeholders about how DSHEA has aged-and what a DSHEA 2.0 should look like. What, if any, changes to the law are needed? What changes are needed in the way FDA polices the market?

Following its own evaluation of the safety and toxicology of AlaskOmega 50% and 70% omega-7 concentrates, the U.S. Food and Drug Administration does not dispute the GRAS status of the ingredient. 

The House of Representatives has passed the Secure and Fair Enforcement (SAFE) Banking Act of 2019, a bill that creates protections for depository institutions providing financial services to cannabis-related legitimate businesses. 

Manufacturers and retailers must avoid making claims and instead focus on delivering high-quality products, one CEO writes.

Senate Leader Mitch McConnell (R-KY) inserted “report language” into an appropriations bill being considered by the Senate Agriculture Appropriations Subcommittee that demands FDA take significant actions with respect to products containing cannabidiol (CBD). 

Most U.S. adults take one or more dietary supplements. With a growing number of users, it is imperative that more is done to ensure that consumers are protected. One expert explains how to improve traceability in dietary supplement production using a manufacturing operations management (MOM) system.

The Natural Products Association reports that the U.S. Senate Agriculture Appropriations Committee failed to include legislation passed the House of Representatives that would have appropriated $100,000 for the FDA to perform a health hazard evaluation on CBD. 

NSF International has announced it will provide independent testing, verification, auditing, and certification services to consumer products containing hemp and hemp-derived cannabidiol (CBD), including food, dietary supplements, and personal care products. 

As the Centers for Disease Control continues its investigation into vaping-related illnesses, and several states consider banning the sale of flavored vape products, the Natural Products Association is warning Congress that this public health crisis may inevitably extend to cannabidiol (CBD) products. 

According to a report recently published by the American Herbal Products Association dietary supplement recalls are relatively infrequent. 

AIDP Inc. has achieved pre-market approval for novel prebiotic claims after collaborating with the full-service contract research organization Nutrasource Pharmaceutical and Nutraceutical Services. 

NuLiv Science has announced that its InnoSlim ingredient is self-affirmed GRAS after the firm engaged AIBMR Life Sciences, Inc. to convene a panel of experts qualified by training and experience to evaluate the safety of food ingredients. 

Industry associations, testing labs, suppliers, and finished product manufacturers are exercising due diligence, each in their own way, to self-regulate and promote responsible behavior, claims, and best practices in an immature hemp and CBD market.

USDA’s Risk Management Agency announced that industrial hemp growers will be able to obtain insurance coverage under the Whole-Farm Revenue Protection program for crop year 2020, if their hemp is grown for fiber, flower, and seeds. 

Arla Foods Ingredients received a “no objection” GRAS (generally recognized as safe) notice from FDA for the use of alpha-lactalbumin in infant formula. 

Where do hemp and cannabinoid companies fit in the manufacturing standards regimen? This has become the question in the absence of clear FDA guidance and regulations for manufacturing.

Prenexus Health has received a “no questions” letter from FDA following its GRAS (generally recognized as safe) notification for the use of its xylooligosaccharide (XOS) prebiotic, at levels up to 2.4 grams per day, in a variety of foods. 

Four Sabinsa manufacturing sites in Kunigal, Dobaspet, Hyderabad, and Nelamangala, India have received Foundation Food Safety System Certification 22000 (FSSC 22000) certification.

What does research say about CBD’s potential role in sports recovery, and how do sports regulatory bodies view its use?

ExcelVite has announced that it has obtained certification from the Malaysian Sustainable Palm Oil Supply Chain Certification Standard (MSPO SCCS) after an extensive audit by the Standard and Industrial Research Institute of Malaysia. 

Deerland Probiotics and Enzymes has announced that it has received a GRAS (generally recognized as safe) no-objection letter for FDA for its Bacillus subtilis DE111 branded probiotic. 

Chemi Nutra warns that synthetic Alpha-Glyceryl Phosphoryl Choline is making its way into the market by posing as the company’s branded ingredient. 

ChromaDex is one step closer to regulatory approval in the European Union with this positive opinion from the European Food Safety Authority.

Prior to FDA's amended color additive regulation, soy leghemoglobin, used in the Impossible Burger for meat-like taste, texture, and aroma was only approved in products sold to consumers in cooked form, meaning that Impossible Burger was only available in participating food service locations. 

The authors write: “It seems that foods and beverages containing CBD are likely to remain high-risk, while dietary supplements would appear to be a slightly lower-risk option for manufacturers or distributors of CBD-containing products.”

Natural Remedies' branded turmeric extract, Turmacin, is now self-affirmed GRAS (generally recognized as safe). 

Former FDA commissioner Scott Gottlieb, MD recently wrote an opinion piece in the Washington Post about how the agency should handle cannabidiol (CBD) in food and dietary supplements. 

Amarin Pharma has filed a petition for certiorari asking the Supreme Court to review a decision made by the U.S. Court of Appeals for the Federal Circuit to uphold a 2017 decision of the International Trade Commission (ITC) not to investigate Amarin’s complaints against manufacturers of omega-3 EPA concentrates. 

The meeting convened federal agencies USDA, FDA, and EPA as well as the testimony of industry stakeholders providing important perspectives when it comes to farming and testing of hemp crops and extracts.

As FDA considers a potential regulatory pathway for hemp-derived CBD products, the agency continues to take action against firms making unsubstantiated claims.