FDA and cGMP obligations, labeling, hemp and CBD regulation, imports, exports and international requirements.
Opportunities There are opportunities for overseas specialty food manufacturers and brands to successfully launch products in the U.S. American consumers continue to embrace imported quality food products. Nutrition 50 has the experience and expertise to help small or medium-size companies overseas with successfully registering and gaining the import approvals at a lower cost. Registering with…
Are you a small to medium sized dietary supplement marketer? Do you have a warehouse where you store and ship dietary supplements or functional foods to your customers?. Do You have contract manufacturers that provide you with product? Do you have cGMP Standard operating procedures written and in place for your operation. Are they kept…
The US FDA has imposed new rules that change the current construct of the Nutrition Facts Panel For Conventional Foods. Companies with less than 10mm in Annual revenue have until July of 2021 to comply. Businesses with greater that 10mm must comply by July of 2020. Here is a summary of the changes: Summary of…
The smaller and innovative companies often do not have the personnel or knowledge bank to handle and successfully provide the ever-increasing document load to gain import approvals..It can be very time-consuming and often the “paper trail” is so multi-faceted that it seems to be “not worthwhile”. Health Ministry approvals can take a long time, sometimes…
So at this time, even if these operations have FDA GMP Compliant standards as outlined in the CFR 21 Part 111 for dietary supplements and part 110 for foods with the written documentation and employee training manuals in-house, they now must go to a third party certification company. In dietary supplements, this is NSF https://bit.ly/2I7NVGO …
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GMP GMP (Good Manufacturing Practices) guidelines within the dietary supplement category can be found in the CFR (Code of Federal Regulations) 21, part 111, and for Foods in Part 110. Essentially, these are basic guidelines to provide a road map to constructing Standard Operating Procedures (SOP’s) and the documentations required for compliance. These include, but…
The U.S. is lifting its nuclear sanctions on Iran as part of the landmark deal, but many business sanctions will remain in place. It will still be almost impossible for most U.S. businesses to set up a physical presence in Iran or partner with Iranian companies. In contrast, Europe is opening up almost all trade…