We Built What the FDA Wouldn't

Two Vials. Same NAD+. Different Lanes.

They wouldn't build it. So we did.

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.  

What injectable NAD+ does

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:

1. ATP production. 

• • The mitochondria convert food into the energy currency the rest of the body draws on. They cannot do that conversion without NAD+ as a co-factor.
  • In a 2016 Cell Metabolism study, aged 32-month-old mice had roughly half the NAD+ of young mice, and that depletion tracked directly with mitochondrial dysfunction. The authors traced the effect to the NAD+-degrading enzyme CD38 (Camacho-Pereira et al., 2016).²
• Sirtuin activation. 
  • Sirtuins are a class of proteins that decide which genes turn on and off as cells age. They cannot fire without NAD+.
  • In a 2013 Cell paper from Harvard's Sinclair lab, restoring NAD+ levels in aged mice reversed key markers of mitochondrial decline within days in a sirtuin-dependent mechanism. Treated tissue resembled that of young mice on multiple measures (Gomes et al., 2013).³
• DNA repair. 
  • PARP enzymes use NAD+ to repair damaged strands of genetic material. Damaged cells either get patched, or they do not.
  • In a 2017 Science paper, raising NAD+ in old mice restored PARP1 activity to levels similar to those in young mice and reduced DNA damage, including in mice subsequently exposed to radiation (Li et al., 2017).⁴

Peer-reviewed studies have documented strong negative correlations between age and NAD+ concentration in human tissue (Massudi et al., 2012)⁵. The decline tracks with the cellular dysfunction associated with aging.

What injectable NAD+ does is restore the substrate to the level the cellular machinery needs. Subcutaneous administration delivers NAD+ in the 90 percent or higher bioavailability range typical of small-molecule subcutaneous routes per published pharmacokinetic literature.¹

That amplitude produces a time-localized tissue spike. It is the kind of rise the cellular machinery draws on for restoration moments.

When NAD+ runs short, cells protect energy production first. Repair and gene regulation lose out.

So if the biology is settled, and the research confirms that NAD+ works...

Why has affordable, safe access stayed broken for years?

The two broken options patients faced.

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:

• Price. Per-session pricing varies by clinic, and most major-market clinics charge a multiple of an entire month of oral support.
• Friction. Travel, scheduling, in-clinic time.

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.

Customers buy them and self-administer with no physician, no protocol, no quality control:

• Contamination.
• Dosage errors.
• The vials look identical to the real thing.
• The supply chain is what nobody is checking.

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.

So the patient gets forced to choose.Sterile and out of reach, or affordable and risky.

The middle did not exist.

What we fought for in Washington.

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.

• In 2022, when the FDA moved to strip NMN out of the dietary supplement category, the coalition pushed back hard enough to keep it on the shelf. The agency's official position has never been formally reversed.
• In 2023, the FDA moved nineteen popular peptides off the approved compounding list overnight. Peptides physicians had been prescribing legally for years through 503A pharmacies. RFK Jr. himself called the 2023 move illegal. The industry pushed back.
• In 2025, the FDA agreed to reconsider seven of those peptides.

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:

• USP <797> sterile compounding
• Lot release testing
• ICH Q3C residual solvent documentation
• USP <85> endotoxin documentation

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.

The safe lane we built.

Black Forest MD is the clinical service we built to fill the vacuum. The NAD+ Injector Pen is what we built to close the gap. Physician-prescribed. 503A-compounded. The first NAD+ pen designed for safe use at the kitchen counter, not the clinic chair.

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:

1. Every kit is compounded at the pharmacy partner under sterile pharmaceutical standards.
2. Every cartridge ships with documentation, the protocol, and clinical support attached to your file.

Here is what the protocol actually looks like.

Two to three subcutaneous shots a week. Preferably in the morning. The molecule arrives in the window the body is drawing on it. Never at night (NAD+ is stimulating at the cellular level, and an evening dose disrupts sleep onset.)

The dose ladder titrates across five weeks:

• Women. Start at 10 mg per shot, work up.
• Men. Start at 20 mg per shot, work up.

In clinical experience, patients on this protocol do not commonly report needing dose escalation to maintain effect, though individual responses vary.

The pen confirms the dose in a window before delivery. No measuring, no mixing. Thirty seconds at your kitchen counter.

The clinic protocol, without the clinic chair.

Two common placement patterns within a 2–3 shot week:

• Morning after poor sleep. Single nights of short or disrupted sleep can transiently deplete cellular NAD+. A morning shot supports the recovery window.
• Days of higher metabolic or recovery demand. Periods of disrupted sleep, recovery from illness, or other clinically relevant demand windows your prescriber has identified.

What we need you to do.

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:

• First invitation to intake. Before the protocol opens to the general public.
• Founding-member pricing. Locked in for the life of your subscription, regardless of future public pricing.
• Priority physician review. Dr. Moulavi and the BFMD clinical team review founding-member intakes first.
• Cold-chain delivery of the kit after approval, with first-dose clinical support included.

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.

JOIN THE EARLY-ACCESS LIST →

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.