I would talk about the usefulness of these controls, give good examples of why these should be followed and what happens when they aren’t.
Everyone complains about documentation until someone ask “has someone given them their medication?”.
O also distinguishing yourself by talking about what you think should be done compared to what the “overbearing government” thinks should be done can work well.
Why not turn this into marketing? If you’re so compliant, set the bar and show all the lab tests (or whatever you gotta do) and challenge consumers to find lab tests for their product?
Chances are, if it’s not a NutraBio product, they won’t be able to.
The third-party lab test is always my trump card. If someone’s like “you guys are all over NutraBio’s jock” then I’m like, “Well, I’d be all over someone else’s jock too if they proved to me what’s in that bottle is on the label and they disclosed where it was made and not in a bathtub”.
But for some odd reason, they always fail to do that, even though they have to get their stuff lab tested anyway (right?)
Of course I acknowledge that publishing 3rd party lab tests only pleases a niche of us. The rest of everyone else wants candy in a jar and hot instagram babes to send them kissy duck faces or whatever they’re doing nowadays. But if you want to play the compliance card, then play it. Because from the outsider’s perspective I have literally no proof that it’s not made in a bathtub, despite how much I love your brand.
Yeah but we blend all our stuff in an FDA registered bathtub okay.
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There’s legal and competitive reasons not to publicly publish your MMR/QC records.
Yohimbine was corrected and magnesium added to all label as of today. The website will be upadted with 48 hours… Thanks for your input.
I don’t appreciate the Federal governments over-reaching into the private sector and their seemingly unquenched desire for overregulation. I believe firmly in the 10th amendment which limits Federal Government powers to those expressly granted in the Constitution, which are very few. Unfortunately, the 10th Amendment was relegated useless by the passing the Commerce Act.
That being said, surprisingly I’m a big believer in, and supporter of Federal regulation 21 CFR Part 111 for the Dietary Supplement Industry. The industry plays by the rules of the wild west, anything and everything goes and there are a lot of shady characters. CFR111 reigns that in, protecting consumers. The reg is difficult and expensive to adhere to if followed it correctly. But it is well worth it for the health and safety of the consumer. The regs are intensive, but I don’t believe there is much waste there. Everything required by CFR111, less a few minor issues, should be done by any quality company of their own free will. It doesn’t just protect the consumer; it protects the business and the industry. So it has my full support…
If? Is it not a requirement? Or do people just skirt around it?
Passed by Congress in 2008 and it is a requirement, but most companies do skirt around it because although Congress passed the law they never gave the FDA funding to enforce it. 2016 total budget for the FDA Dietary Supplement oversite was $4M. That’s for all aspects, not just CFR111.
You hit the issue dead on: “The money we spend on compliance, others spend on marketing, or just having higher cash margins to profit-take or roll out products on faster timelines.” Could not have said it better… Most brands don’t care about quality, especially the Legacy brands. Marketing hype and being cool drives their business and unfortunately many consumers buy into it. Compliance is the cheap part. Many contract manufacturers are compliant with CFR 111 and other regs, but the formulas they put hidden in proprietary blends are cheap garbage. You need both quality manufacturing and quality formulation to make a great product. That combination is expensive. Throwing together a serving of 7-8 grams serving of prop-blended ingredients, then overloading stimming it, is cheap $4 to $6 for a finished product. Create a PWO with 20-25G of full therapeutically dosed ingredients, that will cost you… Quality manufacturing with without quality formulations means nothing. Both are required to serve the customers best interest in creating a product that is safe, efficacious and will give results.
I think the worst part of everything you just said is that it’s hardly groundbreaking, yet here you are breaking ground by doing it. Thanks Mark!