By Antonio Colmenares
Two Vials. Same NAD+. Different Lanes.
The FDA refused to open a consumer pathway for injectable NAD+. The pharmaceutical industry refused to fund the trial that would have forced one.
Neither moved because nobody could patent a molecule the body already makes.
So the protocol stayed locked inside concierge clinic chairs. And underneath them, a gray market grew: NAD+ vials stamped “not for human consumption,” self-administered with no physician and no quality control.
Two players who wouldn’t act. One vacuum. One unsafe market that filled it.
In 2024, when the FDA tried to reclassify NMN as a drug, we filed alongside the Natural Products Association. We rallied the tribe. We won. This is what we built next.
A physician-prescribed, 503A-compounded NAD+ pen. Used at your kitchen counter, not the clinic chair.
This is the molecule, the wall, the fight that broke through it, and the safe lane on the other side.
NAD+drives 95% of cellular energy and repair in the body. NAD+ is the molecule of life.
The problem is NAD+ doesn’t stay constant through the years…
50% of it is gone by age 50 resulting in chronic fatigue, slower recovery, accelerated aging.
30 seconds without NAD+ and you’d be DEAD.
7 of 10 top killing diseases are linked to low levels of NAD+.
This is because three jobs depend on NAD+ inside every cell:
When something forces PARP into overdrive (like accumulated DNA damage), it can pull NAD+ down by up to 80 percent. That leaves the sirtuins and the mitochondria with nothing to work with (Bai et al., Cell Metabolism, 2011; Cantó et al., Cell Metabolism, 2015).
When NAD+ runs short, cells protect energy production first. Cellular repair and gene regulation lose out.
What an injection does is put NAD+ back into the bloodstream at the levels cells need to do their work.
When NAD+ is delivered under the skin, more than 90 percent of the dose reaches the bloodstream. That’s the standard for small molecules given by subcutaneous injection.
Energy production, DNA repair, and gene regulation all wait for moments when NAD+ surges above a normal floor before they start operating at optimal levels.
The injection creates that surge.
So if the biology is settled, and the research confirms that NAD+ works…
Why has affordable, safe access stayed broken for years?
Injectable NAD+ is not new. It has been standard protocol at concierge longevity clinics for over a decade. Tokyo, Zurich, Tel Aviv, Manhattan, Aspen.
Two gates kept that protocol inaccessible to most patients:
The 503A compounding pathway existed. It was the legal lane that would let licensed pharmacies prepare individualized NAD+ for at-home use. But almost no one with the clinical infrastructure built the consumer-facing version.
So legitimate injectable NAD+ stayed locked inside the concierge clinic chair.
When the legitimate door is locked, the gray market fills the gap.
Research-chemical vendors sell NAD+ vials stamped “not for human consumption.” The label is a legal dodge. It keeps the seller outside the FDA’s drug and supplement jurisdiction. Everyone in the chain understands what is actually being purchased.
The supply chain behind those vials is the part nobody talks about. The bulk of gray-market NAD+ and peptide compounds trace back to Chinese chemical manufacturing facilities that produce reagent-grade compounds for laboratory research.
These facilities operate outside FDA inspection, and they do not:
❌ Test for endotoxin.
❌ Run residual solvent analysis.
❌ Certify cold-chain shipping.
The vial that arrives at a U.S. customer’s door has been through container-shipping temperature swings, customs holds, last-mile delivery in unrefrigerated mailers.
The “research use only” label is the seller’s legal protection, not a safety claim. In a December 2024 warning letter to one such supplier, the FDA called the disclaimer “a ruse” to avoid regulatory scrutiny (FDA Warning Letter, Summit Research Peptides, 2024).
What gets injected and what was synthesized are not necessarily the same molecule.
Customers buy them and self-administer with no physician, no protocol, no quality control:
When something goes wrong, there is no physician to call, no pharmacy to recall the lot, no regulatory body the customer has standing to complain to. The deniability is structural.
This injector pen did not get built in spite of the regulatory vacuum. It got built because of it, by the people who refused to leave the lane closed.
We are a member of the Natural Products Association, the trade coalition that represents the natural-products industry in Washington.
This injector pen is what happens when that fight finally finds a legal lane.
503A compounding pharmacies are a real federal regulatory category. Section 503A of the Federal Food, Drug & Cosmetic Act, on the books since 1997, authorizes licensed pharmacies to prepare customized medications for individual patients under prescription.
Strict standards apply:
The pharmacy partner for the BFMD protocol meets all of them.
The lane exists. The FDA did not ban it. The reason most patients have never accessed injectable NAD+ through this lane is that almost no one with the clinical infrastructure, the pharmacy partnership, and the patient-onboarding system bothered to build the consumer-facing version.
We built it.
That is what the fight in Washington was for.
Black Forest MD is the clinical service we built to fill the vacuum.
The NAD+ Injector Pen is the first NAD+ pen designed for safe home use. What you couldn’t get for a decade. Physician-prescribed. 503A-compounded. On your kitchen counter, not the thousand-dollar clinic chair. Not the gray-market gamble.
Every prescription is reviewed by a licensed physician before fulfillment. Our medical director, Dr. Sasson E. Moulavi, M.D. (Dr. Sass), is a board-certified bariatric physician with over twenty years in metabolic medicine and a member of the American Academy of Anti-Aging Medicine.
He trained at the University of Toronto and McGill, and runs LaviMD anti-aging center in Boca Raton, Florida. Dr. Moulavi oversees the BFMD clinical protocol and the patient-review process. Every kit is compounded under sterile pharmaceutical standards. Every cartridge ships with documentation, the protocol, and clinical support attached to your file.
Your body runs NAD+ on a 24-hour clock. Levels rise in the morning, peak during your active hours, and fall as you wind down. The enzymes that make NAD+ rise and fall on the same daily cycle (Nakahata et al., Science, 2009; Ramsey et al., Science, 2009).¹²
A morning shot lands the high-concentration spike when your cells are already drawing on it. An evening shot fires your cells during the hours your body needs to wind down. Morning is biology, not preference. That is why NAD+ is never taken at night.
The protocol, in plain steps:
Dosing is individualized at intake by your prescriber, based on your medical review. In clinical experience, patients on this protocol do not commonly report needing dose escalation to maintain effect, though individual responses vary.
When to deploy your shots in the week. Common placement patterns your prescriber may suggest:
No travel. No clinic chair. No prescription refill phone tag.
The clinic protocol, at your home.
The NAD+ Injector Pen is not yet available to the general public. Founding members on the early-access list will be invited to complete the medical intake before the protocol opens to general access, at founding-member pricing that locks in for the life of the subscription!
What founding access includes:
Here is what we need from you:
Join the early-access list. Add your name below. You’ll be invited to complete the medical intake before the protocol opens to the general public.
Share this with one person. Anyone who has watched someone they love age faster than they should. Anyone who has paid concierge rates and wants the protocol at home. Anyone who has bought a “research use only” vial and hoped. Forward them this blog.
Tell us your state. Drop a comment below with your state. We’re tracking demand to expand availability in the states that show up first.
The molecule isn’t dangerous. The regulatory vacuum is.
We built the safe lane. Walk it.
Antonio
CEO, Black Forest MD
BFMD is currently available to adults 18+ in select states. State availability is confirmed at intake. Communications between you and your clinical team will be handled under our Notice of Privacy Practices.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
