Discussion Bulletpoints
DIETARY SUPPLEMENT LABEL-OWNERS HAVE A GROWING FDA PROBLEM!
1) FDA's Dietary Supplement cGMPs from 2010:
"...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained."
Federal Register, page 34811
This regulatory challenge has become more serious recently and the future appears increasingly dangerous for not just start-up and established vitamin companies, but for every physician, chiropractor or other health care practitioner who owns his or her own "private label" products.
NutraIngredients-USA - 5.10.13
"FDA warning letter: obligations of private label distributors: A new FDA warning letter outlines the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’."
FDA News.com - 3.27.13
"FDA on the hunt..."
"Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus..."
2) If you do not meet this regulatory challenge, you could spend hundreds of thousands of dollars defending yourself against the FDA, and your business could be ruined.
a) EVERY dietary supplement company will be inspected this year, and most likely, yearly, by the 7,000 new FDA agents.
b) You could end up like one company in California where an FDA inspection discoverd, unknown to the owner, certain ingredients from China were illegal drugs. That company spent $250,000 to stay in business.
3) Our Regulatory Compliance Network is headed by Ralph Fucetola JD, the Vitamin Lawyer, with 40 years experience in the nutrient and natural product industry.
Counsel Ralph has worked with many of the leading pioneers in the industry. People like Dr. Mercola, Durk Pearson, the Life Extension Foundation. He practiced law for 36 years and has held executive positions in several start-up and established companies, such as TrimSpa.
Ralph provides the cGMP compliant Standard Operating Procedures (SOP) format for your company and then trains your staff in implementing the standards. He certifies your employees as properly trained.
4) It's easy to get started. Check out his site, www.SOPcertification.com. Ralph will be happy to provide you with a free initial consultation, to determine your status.
Do you have written SOPs? Have you filed the FDA-required Structure and Function Claims Notices?
Do you have lawful substantiation for your claims? Are you ready for the inevitable FDA audit?
"The FDA showed up unannounced. Said they’d be here for at least six days. We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A. C. Company CEO
1) FDA's Dietary Supplement cGMPs from 2010:
"...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained."
Federal Register, page 34811
This regulatory challenge has become more serious recently and the future appears increasingly dangerous for not just start-up and established vitamin companies, but for every physician, chiropractor or other health care practitioner who owns his or her own "private label" products.
NutraIngredients-USA - 5.10.13
"FDA warning letter: obligations of private label distributors: A new FDA warning letter outlines the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’."
FDA News.com - 3.27.13
"FDA on the hunt..."
"Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus..."
2) If you do not meet this regulatory challenge, you could spend hundreds of thousands of dollars defending yourself against the FDA, and your business could be ruined.
a) EVERY dietary supplement company will be inspected this year, and most likely, yearly, by the 7,000 new FDA agents.
b) You could end up like one company in California where an FDA inspection discoverd, unknown to the owner, certain ingredients from China were illegal drugs. That company spent $250,000 to stay in business.
3) Our Regulatory Compliance Network is headed by Ralph Fucetola JD, the Vitamin Lawyer, with 40 years experience in the nutrient and natural product industry.
Counsel Ralph has worked with many of the leading pioneers in the industry. People like Dr. Mercola, Durk Pearson, the Life Extension Foundation. He practiced law for 36 years and has held executive positions in several start-up and established companies, such as TrimSpa.
Ralph provides the cGMP compliant Standard Operating Procedures (SOP) format for your company and then trains your staff in implementing the standards. He certifies your employees as properly trained.
4) It's easy to get started. Check out his site, www.SOPcertification.com. Ralph will be happy to provide you with a free initial consultation, to determine your status.
Do you have written SOPs? Have you filed the FDA-required Structure and Function Claims Notices?
Do you have lawful substantiation for your claims? Are you ready for the inevitable FDA audit?
"The FDA showed up unannounced. Said they’d be here for at least six days. We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A. C. Company CEO
