fda
New FDA Inspection Tips from AHPA
The American Herbal Products Association’s (AHPA) teleseminar played a large role in helping the dietary supplement industry recognize and observe good manufacturing practices. The two-hour teleseminar, held in the middle of May, had industry legal experts, including Justin Prochnow, Esq, Marc Ullman, Esq and Ashish R. Talati, Esq provide pertinent tips on U.S. Food and ...
NPA Adds Another to List of Top Employees
Immediately following the hire of Daniel Fabricant, PhD, as CEO, the Natural Products Association (NPA) has brought on Corey Hilmas, MD, PhD, as the new senior vice president of scientific and regulatory affairs. Hilmas served the U.S. Food and Drug Administration (FDA) for two years as the chief of the Dietary Supplement Regulation Implementation Branch ...
Sweeten Up With Natural Alternatives
New FDA regulations will highlight added sugar content on the labels of food and beverages where it can’t be ignored or buried in ingredients lists. Suppliers are responding with sugar substitutes that sweeten the pot in both taste and nutrition. This past February, the U.S. Food and Drug Administration (FDA) announced proposed changes to food ...
Bringing Others’ Big Ideas To Market
Flexibility, specialization, speed and regulatory compliance make contract manufacturers competitive in the natural products marketplace.IFC Solutions, formerly International Foodcraft Corporation, which was founded in 1939, and changed its name in July, is a producer of finished product ingredients. For the New Jersey-based company, the current state of the market of its contract manufacturing business is ...
Preparing For An FDA Audit
NIE highlights the resources available and pitfalls to avoid so companies are completely prepared when an inspector comes knocking.In June 2007, the United States Food and Drug Administration (FDA) issued the Dietary Supplement Current Good Manufacturing Practice (cGMP) Final Rule 21 CFR Part 111. In essence, the final rule requires that the proper controls be ...
NDI Update
Industry offers reaction to the FDA NDI draft guidance, NDIN experiences and suggestions for proceeding until a finalized version is put forth.Since the 1994 passing of the Dietary Supplement Health and Education Act (DSHEA), the industry has had limited guidance on the statute requiring the submission of new dietary ingredient notifications (NDINs) to the U.S. ...
Focus On Food Safety
NIE discusses the implications posed by FSMA with industry representatives, and their work to meet the challenges head on.In 2007, the U.S. Food and Drug Administration (FDA) published a “Final Rule,” establishing FDA regulations, which require current good manufacturing practices (cGMP) for dietary supplements (21 CFR 111). The final rule addresses in particular the identity, ...
Policing Claims
Claims that can be used on food and dietary supplement labels fall into three categories: health claims, nutrient content claims and structure/function claims. The responsibility for ensuring the validity of these claims rests with the manufacturer, Food and Drug Administration (FDA) or, in the case of advertising, with the Federal Trade Commission (FTC.)Section 403(r)(6) of ...
Delivering In Detail
While clients’ quality, cost and speed demands must be met; today’s regulatory environment emphasizes the importance of partnering with a contract manufacturer that can help a company confidently go to market.Every company, regardless of size, has one goal: to be bigger. To grow its product lines, its market share, its customer base and, ultimately, its ...
GMPs: One Year Later
As FDA audits have begun, the consensus is that the industry still has a long way to go proving its compliance, but it’s making a concerted effort to reach that goal. Setting a three-year timeline for industry-wide good manufacturing practices (GMP) compliance seemed ample, but as it has passed and U.S. Food and Drug Administration (FDA) ...
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