Regulatory

What does CBD’s legal and sales status look like in 2020?

FDA announced supplements that contain a daily serving of 500 mg of whole-fruit cranberry may now use a qualified health claim on their labels and in their marketing materials.

It will be moderated by Lance Blundell, Esq. General Counsel for cbdMD. Owen Bennett from Jefferies, Rupesh Parikh from Oppenheimer & Co, and Ashok Kumar from Think Equity will have a Q&A with Daniel Fabricant, PhD, president and CEO of Natural Products Association.

NuLiv Science received Novel Food status approval from the European Food Safety Authority (EFSA) for its flagship ingredient, AstraGin.

PLT Health Solutions Inc. has received a license from the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada to market its ingredient AlvioLife to support respiratory health in Canada.

What does the state of botanical adulteration look like these days, given the supply-chain upheaval brought about by COVID-19 and the general ongoing propensity for bad actors to adulterate?

Congressmen Morgan Griffith (R-VA) and Kurt Schrader (D-OR) introduced new legislation, called “The Hemp and Hemp derived CBD Consumer Protection and Market Stabilization Act of 2020.”

The Council for Responsible Nutrition-International published two conference reports: “From Lifespan to Healthspan: The Role of Nutrition in Healthy Ageing” in the Journal of Nutritional Science and “Measuring Health Promotion: Translating Science into Policy” in the European Journal of Nutrition.

CBD’s growth in food and beverages is undeniable as more states move to make CBD a legal food and drink ingredient. Will this change FDA’s mind about CBD foods’ legality? Attorney Ashish Talati provided an updated look at CBD food’s regulatory status.

The American Herbal Product Association joined 16 other trade associations as part of the Food and Beverage Issue Alliance (FBIA) requesting more time for small businesses to understand and comply with the new nutrition-labeling regulations that were issued and finalized on May 27, 2016.

For U.S. dietary supplement firms, selling supplements into Canada isn’t as simple as it might seem.

FDA and the FTC have issued SilveryGuy a warning letter, after reviewed the SilveryGuy website and Facebook page in August 2020, and finding claims that imply the product can mitigate, prevent, treat, diagnose, or cure COVID-19.

Both the American Botanical Council and the American Herbal Products Association strongly discourage sales or marketing of dietary supplements that contain any part of the oleander plant.

The Council for Responsible Nutrition has announced that it has transitioned its annual Day on the Hill advocacy event to an online drive, due to the ongoing COVID-19 pandemic.

The Council for Responsible Nutrition has submitted comments to the United States Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) in response to the Dietary Guidelines Advisory Committee’s final scientific report.

GanedenBC30, a branded probiotic used in multiple food and beverage categories, was approved in Australian and New Zealand for a range of digestive-health claims supported by a wealth of scientific evidence.

AHPA supports the addition of pullulan to the National List at 7 CFR § 205.605 as a nonagricultural (nonorganic) ingredient that can be used only in tablets and capsules for dietary supplements labeled, “Made with organic (specified ingredients or food group(s)).”

What is FDA’s stance on CBD in cosmetics?

U.S. Senator Ron Wyden (D-OR) will deliver the keynote at the American Herbal Products Association’s second annual Hemp-CBD Supplement Virtual Congress on August 27, 2020.

FDA issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate, or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act.

This is the first time hemp has been grown, harvested, and processed on Texas soil, following the passage of House Bill 1325 into law on June 10, 2019 by Governor Greg Abbott.

Blue California (Rancho Santa Margarita, CA) has filed a patent for the therapeutic uses of ergothioneine.

A taxonomy change for the Lactobacillus genus will impact probiotic product labels, product claims, GMPs, and more.

The bill provides a funding increase of $5 million to protect the public from cannabis-derived products that are in violation of the Federal Food, Drug, and Cosmetic Act, as well as to create a potential regulatory pathway for cannabis-derived products.

In its report to House and Senate Committees on Appropriations, FDA broke down the results of several years of sample studies the agency conducted on CBD products from 2014 to 2020.

Socati Corp. (Austin, TX) received USDA organic certification for its CBD ingredient line for finished products.

Although the safety and efficacy of authentic English lavender oil have been documented in published clinical trials, due to the comparatively high cost of English lavender essential oil, substitution with other, lower-cost species of Lavandula has been reported.

Artemis International is strengthening its partnership with the American Botanical Council’s Botanical Adulterants Prevention Program and botanical testing specialist Alkemist Labs to investigate suspicions that adulterated elderberry ingredients are infiltrating the U.S. market.

The National Health Commission of the People’s Republic of China approved three patented probiotic strains from Lallemand Health Solutions as safe for use in infant food.

The revised guidance reflects the addition, in January 2020, of cannabis smoke and delta-9 tetrahydrocannabinol (THC) to the Prop 65 list of chemicals known to cause reproductive toxicity.