U.S. Food and Drug Administration
TopGum Triples Capacity With $30M Investment in New Plant
Gummy supplement manufacturer TopGum Industries, Ltd. has begun construction of a new, $30 million (U.S.), 11,000m2 plant 1.5 hours south of Tel Aviv, Israel. The facility, joining the company’s existing production plant, is expected to be fully operated in mid-2023 and triple the TopGum’s production capacity. Fully equipped with high-precision manufacturing technology adapted to TopGum’s ...
Lycored Opens New Facility in New Jersey
Lycored has launched a state-of-the-art processing facility in Branchburg, NJ for its carotenoids, vitamins, minerals, amino acids and real food ingredients. The new plant enables the company to maximize the purity, efficacy and shelf-stability of its ingredients while exponentially increasing output capacity. It provides advanced capabilities for milling, blending, drying and coating, with extensive opportunities ...
FDA Announces Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure
In a letter of enforcement discretion released on Jan 10., the U.S. Food and Drug Administration (FDA) announced that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension), provided that the claims are appropriately worded to avoid misleading ...
NJ Labs to Release ‘Going Beyond Testing’ Podcast Series
New Jersey-based NJ Labs will release a new podcast series called, ‘Going Beyond Testing’ in 2022 to give companies and consumers an insider’s look at testing practices and what should be tested to keep products safe and effective. The series will cover the importance of analytical testing, emphasizing transparency and integrity in the testing practices and ...
NPA Sues FDA: Asks Courts to Block “Unlawful Action” in NAC Situation
The Natural Products Association (NPA) filed a lawsuit against the U.S. Food and Drug Administration (FDA) requesting that the agency cease its unlawful retroactive application of the Food, Drug and Cosmetic Act against N-acetyl-L-cysteine (NAC). “We are very concerned that a safe, legal natural product that has been sold for over 30 years is under ...
Associations Comment on the Nomination of Robert M. Califf for FDA Commissioner
On Nov. 12, President Biden announced that he will nominate Robert M. Califf, MD for commissioner of the U.S. Food and Drug Administration (FDA). Califf is an internationally recognized expert in clinical trial research, health disparities, health care quality and cardiovascular medicine. He has nearly four decades of experience as a doctor, researcher, leader and ...
Nutrasource Joins NASC as Preferred Supplier
Nutrasource Pharmaceutical and Nutraceutical Services (Guelph, ON, Canada), a global full-service contract research organization (CRO), has announced its membership into the NASC (National Animal Supplement Council) as a Preferred Supplier. Preferred Suppliers are companies that are pre-qualified to supply products and services to NASC Primary Suppliers without additional vendor qualifications that fall under NASC cGMPS ...
NJ Labs Celebrates 85 Years in the Testing Industry
While Dr. David Levowitz was at Rutgers University, he saw a growing need to promote quality in dairy and food production, so he created New Jersey Dairy Laboratories in 1936 for that purpose. At that time, he likely had no idea how comprehensive his laboratory would become. As NJ Labs (New Brunswick, NJ) celebrates its 85th year ...
CHPA Will Feature FDA Leadership, Industry Experts During Virtual Regulatory Conference
The Consumer Healthcare Products Association (CHPA) will hold its 2021 Regulatory, Scientific & Quality (RSQ) Conference virtually Sept. 9-10. CHPA said its annual event brings together an array of highly respected experts to discuss timely regulatory, scientific, legal, and product quality topics affecting the consumer health care products industry. After a year of unprecedented change in health ...
NPA Files Citizen Petition with FDA
In a Citizen’s Petition to the U.S. Food and Drug Administration (NPA), the Natural Products Association (NPA) requested that N-acetyl-L-cysteine (“NAC”) not be excluded from the definition of a dietary supplement. “The Food and Drug Administration has not established a public health risk for NAC,” said Daniel Fabricant, PhD, president and CEO of NPA. “Not ...
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