Safety, Efficacy, Consistency.

In August 2018, AcquiFlow’s bio-pharmaceutical group – Pebble – released the first of its hemp-CBD product line; specifically formulated for neurological disorders. Pebble has been featured on The History Channel, has shipped to 49 states, has completed a successful clinical study treating Autistic children ages 5-12 and has now begun to structure a Series-A raise in sync with the FDA’s hemp regulatory rollout.

Why These Critical Elements?

Industry Validity: Self interest of survival. Communal interest of industry success: Consumer interest of quality control.

Legal Responsibility: Product Liability – FDA and USDA.

eg: Vape issue, Washington state epileptic child, National MLM with Lead

Social Responsibility: Depending on us for real medication.

The 1st Critical Element:

Safety

Definition:

Products should be able to be taken at titration consistently with no negative effects.

Current Industry Standard:

No Federal structure/oversight. Regulations are state-by-state, with varying degrees of efficacy or enforcement. Often, products are created at lowest cost available; varying in sourcing, ingredient & testing standards.

Safety – Best Practices (in lieu of federal regs)

● Develop and maintain multiple suppliers of the quality (e.g. organic standards, full spectrum vs isolate), amount and frequency needed of your base hemp ingredient.

● Every supplier should be licensed and regulated by the state in which they operate.

● Every ingredient used in your product should be sourced with the same standard of care as you do hemp.

● All ingredients should be independently third-party tested (e.g. Pebble requires 3rd-party testing for each raw material prior to processing & then again post-manufacturing for every batch.

● All products should have tamper-proof security packaging prior to distribution.

The 2nd Critical Element:

Efficacy

Definition:

The product effectively solves the problem for which it is intended.

Current Industry Standard:

Unsubstantiated claims abound about what CBD can do for people. The most hard scientific evidence currently centers on treating Neurological conditions, which run the gamet from Autism, PTSD, ADHD and Arthritis to anti-inflammatory/anti-nausea pain management. However, the vast majority of CBD providers have no idea regarding critical dosing protocols (e.g. what kind of CBD/cannabinoid-profile, how much & how often)

Efficacy – Best Practices (in lieu of federal regs)

● Ensure extraction technique used preserves terpene profiles, so that resulting oil maintains same medicinal value as the fresh plant that entered process.

● R&D: are you providing the right cannabinoid profile for the specific disorder for which your customer is purchasing the product (e.g. CBG & CBN for seizure-disorder patients).

● Easily-obtainable 3rd party lab-results that confirm exact milligram of CBD, overall concentration, solvent/lead/pesticide free are critical.

● Long-term Efficacy is tied to Consistency across batches and should be reflected on all packaging.

The 3rd Critical Element:

Consistency

Definition:

To use as a true medication, products must meet exact standards across manufacturing process, batch-to-batch, in perpetuity.

Current Industry Standard:

Because state-regulated, manufacturing standards can vary county to county in some instances. As of September ‘19, USDA has submitted regulatory draft for White House review. Once approved, states can begin prepping to file their FDA program approvals. All is still within timing for 2020 planting season. Regulatory consistency will be a journey, not an event.

Consistency – Best Practices (in lieu of federal regs)

● If providing for medical purpose, manufacturing process should include batch laboratory analysis to spike/dial-in cannabinoid/terpene profiles to exact specifications.

● Packaging should include metered delivery so caregivers can measure exact dosing.

● When product is ready for distribution, random sample test each batch to confirm it meets every requirement and no shifts in cannabinoid/terpene concentrations.

● Make sure complete 3rd party test results are easy for customers to find (e.g. Pebble provides full testing transparency via our “Track Your Batch” feature at www.pebble.life).

The Pebble Difference: Safe, Effective, Consistent.