When starting and growing a hemp or supplement company, I always suggest hiring a dietary supplement veteran to have an active management role in the company. They will help you set up systems in operations, quality and compliance.
There are many important factors in hemp and supplement manufacturing and having to learn them on your own can hinder your growth in this fast-moving world. cGMPs can seem daunting but supplement experts are familiar with the basics such as:
FDA Inspection Readiness, watch my webinar here
Controlled entry
Label control
Component specifications/release
Finished product specifications/release
Checked and Verified By System
What Regulations for CBD?
As we know the FDA’s position on hemp-CBD is unclear, this doesn’t mean that no compliance is needed. In lieu of clear FDA guidance, cGMPs for dietary supplements provide a good guideline to address truthful labeling, and quality, there is no reason for the hemp industry to reinvent itself. View this free cGMP Basics for Hemp-CBD Companies webinar here.
There are many important regulatory factors in manufacturing and marketing, cGMPs can seem daunting. The supplement and hemp world is moving quickly and having to learn GMP’s on your own can hinder your growth.
Dietary supplement veterans have done this before and can give manufacturing or marketing companies a strategic advantage. An ounce of prevention is worth avoiding trouble, Here are reasons to avoid a warning letter or even worse, an FTC administrative action.
Key manufacturing & marketing areas where dietary supplement experience can help your company shine!
Developing and Implementing Quality systems: Dietary supplement regulations allow room for interpretation. cGMPs are a framework of regulations but this can be sloppy or difficult to translate into actuality. It’s hard to know how to implement in a way that makes sense for your situation and company. I always try to hire from the supplement industry, as the interpretation of the regulations can mean the difference between success and failure in the highly competitive hemp & supplement world. I see this all the time in my consulting business.
Operational Systems: This goes hand in hand with Quality Systems. Help support Quality Systems that ensure products are made efficiently at a high-quality standard, but also keep in mind costs such as headcount and opportunity cost for not shipping QC cleared products promptly. I speak about optimizing customer experience here.
Marketing Compliance: Communicating a marketing message without inadvertently getting into FDA/FTC and class action trouble is essential for long-term company growth. Watch my Labeling & Marketing Claims webinar here.
As companies are looking to gain a competitive edge they are constantly pushing out content. I commonly see companies that have excellent label and manufacturing compliance and are very careful with online marketing campaigns. An unsuspecting company copywriter or social media employee can bring a warning letter by adding the wrong hashtag, infographic, or a well-intended educational post with studies cited.
This is indicative of executives coming from industries such as apparel or tech, and not understanding the smaller but important aspects of what pitfalls to avoid.
I review this here
I suggest company-wide training sessions which include the top execs. This helps weave a culture of compliance into the fabric of the company’s DNA and spreads compliance from within. Read my discussion on this here.
4. Reduce Learning Curve Time: As companies grow, there is always a learning curve to reach operational efficiency. The time saved by not having to learn on the job is crucial in this very rapidly moving hemp and supplement world. A 3-month delay to launch or scale-up can mean the difference between company success or failure.
5. Machinery: Dietary supplement folks know how to look through misleading vendor promises.
High output numbers. If you take vendor Maximum Peak Performance numbers as face value this can lead to inaccurate costing information and can affect how much you charge customers. Not factoring in standard filling deviations can severely hurt your bottom line. This happens all the time. It is called armchair operational planning.
Machine onboarding time. Despite vendor promises no machinery is plug and play. Machines always take longer than expected to set up and get running well. Those with experience factor this in. Setting a reasonable machinery implementation time is important as requesting objectives that cannot be achieved can set up a culture of eye-rolling, or “never cry wolf” where tight deadlines mean little more than wishful thinking. This in turn hurts morale, thus hurting efficiency.
Quality Control: I can't tell you how many softgel machines have been purchased only to learn that making homogenous softgels at scale is difficult. SO MUCH CAN GO WRONG. If you have been around the supplement industry for long enough you have experienced poor quality softgels and know it is not easy to make a lot of perfect softgels on inexpensive equipment.
6. Recruiting: When you hire someone with years of experience, you are not just hiring them, you are also benefiting from their network. This is called network effects and helps a company hire additional positions but also helps with other resources such as ingredient sourcing.
To go a little further into Network Intelligence, all recent jobs I’ve found were unlisted or created for me, and came about through my network. So again, when you hire an industry veteran you are benefiting from their career knowledge and the knowledge and strength of their network as well.
7. Network Benefits: Early in the pandemic, I was researching a product development project and the world was changing day by day. I reached out to my network to see how my colleagues were coping with the vitamin C supply chain and what they were seeing with upcoming packaging supply shortages. This helped me plan the production and purchasing plan accordingly.
What about hiring from other industries?
Generally speaking people from pharma tend to have a stiffer interpretation of the regulations, as we are masters of our reality. There are plenty of excellent people in the pharma industry but generally speaking people from pharma oftentimes lack the flexibility needed in the dietary supplement or hemp industries. A pharma mindset when designing and implementing quality systems can lead to a rigid “interpretation” of the regulations. It is essential to build a robust and well-functioning quality system in place early on, as inefficient practices can become magnified as companies grow, resulting in longer lead times, unnecessary testing, and a silo approach to whole company objectives. This is very common, and I discuss this during my NutraCast interview here.
On the other side, folks from the food industry have a steep learning curve to become accustomed to the more robust supplement cGMPs, and care must be taken to ensure regulations are interpreted correctly and effectively.
Develop in house regulatory expertise:
There are many ways to develop in-house expertise. AHPA webinars and events are a great way to develop in-house expertise. I attribute much of my executive success and my track record of three FDA GMP audits with no 483’s to AHPA education. This is one reason I volunteer so much time to AHPA!
Another way to develop in-house expertise is by consulting attorneys when needed. Here are a few attorneys I like.
I suggest consulting legal assistance when just starting a business. For example, I know a friend's company who started making a CBD cooling salve with a high percentage of menthol. After they released the product they realized having more than a small percentage of menthol turns a product from a cosmetic into an OTC drug. Consulting an attorney would have helped them avoid this costly error.
Also, I like using attorneys as tiebreakers and to help explain the risks associated with certain marketing campaigns as is commonly the case when a CEO or CMO wants to use language I am not comfortable with.
GMP’s are a framework of regulations but this can be sloppy or difficult to translate into actuality.
There is lots of room for interpretation in the regulations and it’s hard to know how to implement them in a way that makes sense to your company. Here is one example of how two cGMP approaches get the same outcome.
Scenario discussion:
The regulations state Design manufacturing processes to ensure product specifications are consistently met.
This, as many areas of the regulations, leaves room for interpretation, but the goal is to ensure the product is made to specification.
Option #1: Hire a full-time member of quality to stand over the packaging line to constantly be checking quality (labels, lot numbers, fill levels, etc).
Discussion: There may be companies reading this who are saying Wait I can’t afford to have a Quality employee on the packaging floor full time.
That’s OK, you just need to interpret the regulations in a way that makes sense for you!
Option #2: Quality staff starts on the line ensuring the bottle fill level is correct, the correct labels are being applied, and the correct product is being used, etc… The Batch Production Record (BPR) can be written so a Packaging Manager or Lead is responsible for in-process checks.
Review: The final lot clearance will always be done by Quality. You are getting the same result from each example, but the implementation is different. By putting some Quality responsibility back to packaging personnel pays dividends, as it helps all employees become an extension of the Quality.
This reduces the Us-Versus-Them mentality which can happen with Packaging and Quality and helps what I like to call the virtuous operations ecosystem, where all departments are working together for a common goal. This is a good example of why you should hire a supplement executive who understands not just Quality Systems but also Operations. Implementing a quality system from a compliant and operational perspective will help your company grow in a lean and efficient manner.
For a free consultation regarding your compliant marketing or quality system review contact me here.
Disclaimer: The educational information provided on this website is for informational purposes only. Contact an attorney for specific legal advice.