Primordial Performance: FDA seizure, going out of business, and the future

UPDATE Dec. 4th, 2013: Please visit Botanical Craft for my latest project with Palm Fruit (antioxidant extract from red palm oil).

 

Original post from Nov. 4th, 2012:
Updated Apr. 14th, 2015 (See bottom)

Customers (and creditors),

Forgive my delayed announcement on our business situation. Since the FDA raid Tuesday morning, I’ve been wrapped up in pressing matters, which I will explain below. I’m sitting here on minimal sleep, but will try to address this completely.

The facts are as follows –

The FDA raided our office/warehouse building in Portland OR at about 9:00am on Oct 30th. They had a search and seizure warrant for the following –

  1. AndroHard, AndroDrive, AndroMass, AndroLean, AndroBulk, AndroEnhance, Sustain Alpha gel, and DermaTherm gel. Including all raw materials for these products.
  2. All computers, digital storage devices, documents from 2006 until current.

There were about 30 armed FDA agents who entered through the front and back of the building with guns drawn. A majority of them were from LA. I have no idea why they had guns. No employees at our office have any history of violence or criminal history.

I received a call about the raid, and immediately went to the office. I asked to speak to the head agent(s), who were Jeff Novitzky and Hilary Rickher. Against the advice of others, I choose to speak to them without an attorney. I handed them our DSHEA statement, sat down and allowed them to question me for about 2 hours regarding the formulation, marketing, and manufacturing of our products. They did not detain or arrest anyone.

As of now, the affidavit for the warrant is sealed, so I am not entirely sure of the justification for the warrant. Based on the agents questioning, here are the major reasons Primordial Performance was targeted –

  1. TREN & Superdrone: The FDA is aware that we sold Tren in 2009 and Superdrone in 2010 for a very short period of time. We sold these products despite FDA warning that they may be unsafe. We deemed these products safe when used according to proper guidelines and suitable for sale given clear warning to consumers about potential side effects. We included this information on the labeling. As Primordial later determined in 2010, these hormones were not naturally occurring in the food supply, and thus would require an NDI to be sold as a dietary supplement. We were not compelled to submit an NDI, therefore we discontinued all methylated steroid hormones by the end of 2010. (to be replaced by naturally occurring unmethylated steroid hormone products called the “Androseries”)
  2. Secret ingredients: The FDA asked if there were any “secret ingredients” added to our products, so they seem to believe we add illegal or unlisted substances to our products. Apparently the FDA has also invested in extensive analytical testing of our products. Based on the limited information I have, they have been unable to find any “secret ingredients” in our products, nor will they ever find any evidence of this. What’s on the label is what we put into the product.
  3. Claims: Related to the AndroSeries products, the FDA had questions related to our claims regarding “AndroSeries equivalent to injectable testosterone.” This was the work of my colorful marketing side, but was substantiated with bio-equivalency calculations from peer-reviewed journal articles. According to the FDA, that statement is a drug claim, and thus the FDA considers AndroSeries marketed as an unapproved new drugs because of this claim. Most companies get warning letters about claims, but we never received any communication from the FDA until the raid.
  4. Ingredients: The FDA also seems to believe the AndroSeries products are “adulterated” because the ingredients are not present in the food supply, and thus, are not legal dietary ingredients. We have evidence that these hormones are naturally occurring in food, present in our bodies, natural human metabolites of DHEA (which is also a legal dietary ingredient), and thus are legal dietary ingredients. The FDA also believes that our doses are excessive, and not proven to be safe. We have evidence to show that our doses are very safe according to our human case studies.
  5. Topicals: They questioned the legal definition of the topical gel products. They seemed to believe we were selling them as dietary supplements. I informed them that they are sold as cosmetic products. The reason for these products being seized remains in question.
  6. GMP, ingredient origin, and other things: They also commented that synthetically manufactured ingredients (our hormones) are not dietary supplements, although 80% of the dietary supplement market comes from synthetically manufactured vitamins, amino-acids, etc. The FDA has also made accusations that our dose of active ingredients has been “inconsistent” between our batches. I am not sure of the origin of this claim. They also pointed out that our production workers were not wearing masks, and that we do not have a temperature controlled facility.

Admittedly, we have struggled to meet GMP guidelines since they became a requirement in June 2010. We started as a home based company in 2006 and moved to a 5000 sq ft facility in 2009, and hired laboratory staff to make efforts to meet GMP requirements. Meeting the multi-point analytical requirements, paper documentation, stability testing, facility upgrades, etc., is extremely expensive. We made a good faith effort to meet these requirements as much as our finances could afford.

As a side note, I feel empathy for the start-up who wants to produce and sell a legitimate dietary supplement in the US. The upfront investment to release a new product could easily be over $50,000 to meet minimum batch sizes required by GMP certified facilities. As of 2010 the law essentially requires manufacturers to use multi-million dollar equipment to test, analyze, verify, scan, pack, and store dietary supplements. The US government needs deregulation here, especially in this economy.

Speaking of the economy, the FDA must have spent over $2,000,000 for the investigation of Primordial Performance and its products (as can be gleaned from the number of agents and depth of the investigation). This seems like a tremendous waste of taxpayer dollars, especially when the FDA could have policed the situation with a simple warning letter.

Where does this leave Primordial products?

The FDA seized our inventory as evidence based on its opinion that these products are misbranded and adulterated. At this point, the products are not controlled substances, so they are not illegal to be in possession of. However the FDA has made it clear they don’t want us to distribute them.

If you are selling our AndroSeries products, I would advise against it at this current time, but there doesn’t appear to be any legal issue with possessing or consuming the products as an individual.

What happens now?

The FDA will now review our 5+ years of company records. They aren’t going to find anything more than what they already know. I really have no idea if they are going to press criminal charges, or if this will all be settled out of court. At this point there have been no criminal charges or arrests.

Again, the affidavit is sealed, so I am unable to see the evidence or reason for the seizure. As with any seizure, there is not much you can do to prevent the items from being seized, and any attempt to get the items back requires a claim to be filed, expensive attorneys, and lengthy court proceedings. The US court system does not move quickly.

Even if we go to court, and prevail in showing the products to be safe and legal dietary supplements, this process could take years. So if we win, we still lose.

Although we don’t have final numbers, it is estimated that the FDA seized up to $500,000k in inventory, valued at over $1,000,000 at its selling price.

From bad to worse

People seem to assume we have millions in the bank, but it couldn’t be further from the truth.

Primordial has been struggling financially for the past several years. We have about $300,000 in debt with various suppliers and creditors. Most of our business trouble was related to excessive overhead, inefficient operations, and employee turnover. Trying to fix these issues in a company is like trying to fix an engine while its running. Primordial has only had one slightly profitable year in the 6 years we’ve been in business. We always operated with very tight cash flow, with most of our cash tied up in inventory. None of the investors or shareholders have ever made any financial gain from Primordial, except for my $60,000/yr salary.

Since AndroSeries was about 80% of our revenue, and it is now gone, it essentially cuts us at the jugular. Before the FDA stepped in, we had a tight, but sustainable business. Now we have no money, no credit, and no inventory. It means doors closed for us.

What made our fall even more abrupt, was the fact that we had been behind on rent payments. We had a strict repayment plan to avoid eviction, but we won’t be able to follow through on those payments now. We will likely be getting locked out of our building by Nov 7th. Because of this, we decided to immediately make arrangements to clear the building and close shop.

The final days

As of 12/30/2012 all employees have been laid off and the final remaining inventory has been sold.

I might walk away with enough to live on for a few months after all payroll, moving, and storage expenses are paid. At this point Primordial nor myself have any income. I am actively seeking formulation/marketing contract work in the dietary supplement industry (non-andro of course). When I begin work for another company I will let you guys know.

Am I going to fight the FDA?

In many ways, I’m eager to have my day of reckoning with the FDA. This story deserves a good ending.

Is our position on the legal status of these ingredients strong enough to hold up in court? How about our safety data? Or our diligent effort to legitimize a safe and legal dietary steroid supplement?

Although I’m still recovering from a major ass kicking, the story of David and Goliath inspires me. I’ve always like fighting hardest when I’ve been the underdog. It’s FDA’s next move, so we will just have to see what happens.

Epilogue

Since I was 16 I’ve invested my life in the study, research, and development of hormone products. I did it for the fun of it. Its always been my personal passion to create something that could produce life changing results for people. The fact that we weren’t making any profit at PP really didn’t matter to me. The reward was the unsolicited letters of gratification from guys who discovered a greater life with our products. I loved creating hormone products, guys loved using them, and it was a great time.

I hadn’t been around much for the past 12 months. I’ve been quite captivated in my most recent work. I was confined in my small studio apartment constructing a plan for my next business. It was a complete male hormone solution, similar to Primordial Performance, but much improved. If this project every sees the light of day, it won’t be for several years.

I thank those who stood by until the very end here at the office, and those customers who maintained great loyalty over the years. I know if you could many of you would suit up and charge into battle. Maybe our day to rally will come.

Humbly & Respectfully,

-Eric Potratz
Primordial Founder & President

Update:

Here is a response to a couple myths I’ve heard over the last couple years:

Myth #1: The FDA raid never happened. Apparently, there is a rumor that the FDA raid was faked so Primordial could shut down and avoid payment of past-due taxes and debt. For the record, we had payment plans established for our debt, and were making an active recovery before the raid. The raid was very real, and the warrant can now be seen here.

Myth #2: The IRS shut down Primordial. Deborah Laughlin, the IRS Revenue Officer assigned to the Primordial account, had no idea about the FDA investigation. I realized this several weeks after the FDA raid when I had a meeting with her in Vancouver to let her know that Primordial was shutting down, and that we would no longer be able to make the payment plan on our past-due payroll taxes. The IRS had nothing to do with Primordial closing its doors.

UPDATE Dec. 4th, 2013: Please visit Botanical Craft for my latest project with Palm Fruit (antioxidant extract from red palm oil).