FDA and cGMP obligations, labeling, hemp and CBD regulation, imports, exports and international requirements.
For branded Dietary Supplement Marketers, there are essential requirements outlined in CFR 21 part 111 of the current Good Manufacturing Practice (cGMP) code that they must adhere to. These regulations encompass various aspects of production, quality control, and documentation. Engaging a knowledgeable professional can significantly enhance transparency throughout the compliance process, facilitating the creation…
cGMP (Good Manufacturing Practices) Compliance: The Vital Quality Pillar for Dietary Supplements Regulatory compliance in the dietary supplement industry can be daunting for emerging manufacturers. With over 1500 inspections conducted by the FDA last year (2024), the need for guidance and support is evident. To find a specific FDA 483 observational report, one must file…
Are you a small to medium-sized branded dietary supplement marketer? Do you have a warehouse where you store and ship nutritional supplements or functional foods to your customers? Do You have contract manufacturers that provide you with products? Do you have cGMP standard operating procedures written and in place for your operation? Are they kept…
If you are a Hemp processor producing cannabinoids, your growth in this expanding market will depend upon your innovation, marketing savvy, and most critically, your unwavering commitment to making the highest quality cannabinoids and not necessarily at the lowest cost. Due to the diversity of different cannabinoids found in the industrial hemp plant, processors will…
The passage of the 2018 United States Agriculture Improvement Act removed industrial hemp, defined as Cannabis sativa L. containing less than 0.3% THC content by dry weight, from Schedule I of the Controlled Substances Act and made it an agricultural commodity. Currently all dietary supplement manufacturers are required to implement the cGMP codes and regulations…
Quality Control Operations Although CBD is neither a dietary supplement nor a food additive, the groundwork for submitting safety data to obtain a new NDI (New Dietary Ingredient) for CBD is underway. Regardless of how long this takes, the market is so large that regulation is inevitable. The FDA often cites written Quality Control Operations…
Although CBD is currently neither a dietary supplement nor a food additive, the groundwork for submission of safety data to obtain a new NDI (New Dietary Ingredient) is underway. Regardless of how long this takes, the market is so large that regulation in this area is inevitable. cGMP will be a requirement. In the CFR…
Batch Record means Manufacturing documentation, packaging documentation, and exception documentation, such as a non-conformance report, Deviation Report and Certificate of Analysis, and additional documentation, which may have been processed as part of the production and packaging records of the Batch; as defined in 21 CFR part 110 and/or 111, or other certifying bodies as specified…
If you are, you will be required one way or another, in the near future to comply with CFR 21 Part 110 or 111, for Food or Dietary Supplements. If you are a brand, not manufacturing your product offerings, you will need: Subpart M Holding and Distributing Subpart N Returned Finished Goods Subpart O Product…
Importation documentation can be very time consuming and requires in many cases authentications and apostilles from states and sovereign consulates. I have been working in the international sector for over 15 years. Selling your offerings overseas once you get through the registration process can be a very lucrative channel broadening your revenue portfolio. Nutrition 50…