Several weeks ago, we wrote about seven regulatory and fundamental compliance areas where emerging brands using the e-tail channel, especially on Amazon, may be taking shortcuts either through ignorance or intention. These shortcuts were likely to create a Transparency Collision as consumers continue to assume that retail provides a gate and that retailers provide the gatekeeper so that consumers can trust what they buy – especially in this category.
We made the point in our original piece that as of November 15, 2017, the number of vitamin category sellers on Amazon alone was 13,929. Additionally, Lucky Vitamins currently lists 2.577 brands, Vitacost lists 563 brands, Vitamin Shoppe lists 921 brands, CVS lists 143 brands with 495 products and GNC lists 34 brands. These numbers are significant and continue to represent an industry vulnerability.
That original list of seven items elements often overlooked by new dietary supplement e-commerce entrepreneurs was well received. So much so in fact, that we’ve been challenged and asked to deepen the list.
The original seven:
- Adverse Event Reporting
- Third party verified testing
- Retained samples program
- Stability Testing
- Allergen Confirmation
- Claim Substantiation
- Quality Control Trained Individual
Now, let’s complete the list by adding:
- SOP Manual including:
- QC/QA Testing Policy
- New Product Development Policy
- Retained Sample Policy
- Recall Program including mock recalls and inspections
- Ingredient Vetting Program
- Label Review Policy
- Contract Manufacturing Qualifying and Review Audit
- Lot and Expiration Tracking Process
- CoA Verification Policy
- Quarantine Procedures
- Continuous training program
And let’s continue to keep in mind that emerging responsibilities are not even considered (such as FSMA roles and obligations). Let’s look a little deeper at our additional nine items:
- A comprehensive SOP Manual is rarely found in recently formed start-up companies, but their importance is clear in cGMP regulations.
- QC/QA Testing Policy: An established policy and process is necessary to insure the correct assay, count, tests and other measures are consistently implemented. We have had clients who have received CofAs from contract manufacturers allowing a 10% under label claim assay of an ingredient as an acceptable starting point for a product with a 3-year shelf life. In this case, the ingredient starts out sub potent and only deteriorates, diminishing the likelihood of effective benefit.
- New Product Development Policy: This policy, and the adherence to the policy, ensures the company, the FDA and the consumer that a full, formalized inspection process has been implemented to ensure safety and efficacy of ingredient(s) decided upon for formulation.
- Retained Sample Policy: Retained samples are a necessary component to a variety of QA/QC processes but retaining the product too long can be as much of a complication as not retaining the product for long enough.
- Recall Program: While only the brand is typically assigned responsibility of being able to navigate a recall under the regulations, all members of the supply chain are involved. All aspects of a potential recall, voluntary or involuntary, should be taken into account by all supply chain participants including contract manufacturers, because the responsibility of action (and fallout) exists throughout the supply chain. Moreover, mock recalls/inspections are as important as fire drills and for the same reason. Preparation and practice will replace chaos and confusion if all parties involved have a clear understanding of the expectations involved with each requirement.
- Ingredient Vetting Program: Differing regulations across countries can prohibit sales for companies doing e-commerce business in those other countries. We have experience with PayPal shutting down an entire United States e-commerce website because persons from the UK were ordering 5-HTP and having it shipped internationally. While 5-HTP is a dietary supplement in the United States, it is classified and regulated as a pharmaceutical ingredient in other parts of the world.
- Label Review Policy: It is not enough to simply review label claims at the launch of a product. It is important to review the label on a timely and regular basis to ensure up to date claims and substantiations are in place.
- Contract Manufacturing Qualifying and Review Audit: Price is too often the single determinant of contract manufacturer selection. cGMP regulations require the brand to be responsible and knowledgeable of all aspects of the manufacturing process and the controls in place. Written and physical inspection are the only manner of assuring this requirement is met.
- Lot and Expiration Tracking: Knowledge of where your product exists in the supply chain is important from both a customer service responsibility as well as potential recall responsibility.
- CofA Verification Policy: Receipt of CofA is not an assurance of quality unless the measurements are reviewed by trained personnel and validated independently on a consistent and prescribed basis.
- Quarantine Procedures: Several times throughout the supply chain, the manufacturing and distribution process requires quarantine of an ingredient or product. It is important to know when and why these quarantine requirements exist and that they are implemented as necessary.
- Continuous training program: To train in all the aspects and requirements of cGMP is not enough. Training requirements as they apply to the products and organization continue to evolve as do the responsible personnel, including staff turnover. Continuous attention to all aspects of the cGMP structure is imperative in maintaining the required degree of responsibility mandated by FDA and that expected by consumers.
We also noted last time that the FDA has the right to inspect any dietary supplement brand for all of the above requirements, and that the reality is that the FDA has limited resources to enforce inspection on even a small portion of the brands currently available. This gap is widening, meaning that more companies are operating at this new fringe, the only common denominator being the contract manufacturers making the products, often from ready-made recipes. While one would think that this should lower or mitigate the risk, we still often find a ‘race to the bottom’ with price pressure leading to suspect products.
We wonder what else can be done, specifically in the online commercial environment, on top of regulatory and current industry initiatives, to ensure that ignorance is fundamentally dealt with, best practices become more widespread and that these new entries and entrepreneurs become model industry citizens. We at Trust Transparency will continue watching this issue, as we work to engage this community.
As promised, we’ll go deeper into both what we find…. And don’t find.
~Scott Steinford & Len Monheit
Scott Steinford and Len Monheit are Managing Partners at Trust Transparency Consulting