60-second interview: Joe Archer, All American Pharmaceutical

All American Pharmaceutical: 'There are a number of manufacturers that will always find ways to cheat and feel the risk is worth it'

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Based in Billings, Montana, All American Pharmaceutical specializes in producing private label and custom formulations for food and dietary supplement firms
Based in Billings, Montana, All American Pharmaceutical specializes in producing private label and custom formulations for food and dietary supplement firms
With the future looking decidedly uncertain for pre-workout stimulant DMAA (1,3-Dimethylamylamine), attention is turning to alternatives, Joe Archer, VP sales and marketing at contract manufacturer All American Pharmaceutical tells Elaine Watson

What are people replacing DMAA with?

Well the cheaters will remain cheaters, but some are fine with caffeine, ​[Yerba] mate extract and Guarana. Some request Synephrine (Citrus Aurantium/bitter orange extract) which is banned by the NFL. The advice we give is if it is banned or in the process of being banned, stay away from it.

What about Dendrobium stem extract?

We have not had any requests for this as of yet…

What are your customers saying about the DMAA issue and regulatory action?

It is mixed. We have steered clients away from it as we knew it would go in the direction that it has gone. The manufacturers that are willing to risk it are upset. But some just want to stay away from any controversial ingredient. Most of the time inquiries about DMAA are from new potential clients and when we mention that we do not deal in it they just go someplace else.

Do you think DMAA or other stimulants will go underground?

Absolutely, there are always manufacturers willing to cheat and try and make a fast dollar instead of doing what it right.

Is the clean-label trend now a big part of the bodybuilding sector or are there still a lot of people out there that aren't bothered about what's on the label - and just want results?  

I think with the new cGMP requirements that companies will attempt to head in the clean-label direction. Of course when there is a demand from consumers, someone will take the chance to fill that demand.  

All of these issues with spiked products and materials are why we test every barrel of raw materials every time: three samples each barrel top, core and bottom.

You test all your raw materials for metals, drugs, banned substances and potential adulterants. How often do you find them?​ 

Our regular vendors know we test so they send us the correct material. When we are approving new vendors or dealing with client supplied materials is when we have the most problems. Being an 'Informed Choice' certified manufacturer gives our clients the guarantee that the products we produce are not contaminated with a banned substance. ​[As for adulteration], we find that materials that can be spiked often do get spiked with something to enhance the material, and by doing so, a lower grade material can be used. The only way to ensure this does not happen is to test each barrel every time. We look at the material and determine what they would spike it with and make sure we test for that substance if we do not already.

Several manufacturers have been prosecuted for spiking supplements with active pharmaceutical ingredients. How big an issue is this?  

There are a number of manufacturers that will always find ways to cheat and feel the risk is worth it.  

Is there an 'understanding' in the hardcore end of the bodybuilding market that if you buy certain products from certain suppliers you'll get something 'extra' (regardless of what is on the label)? 

Yes I would say that would probably be true. But I hope that once the FDA gets through inspecting all of the facilities these types of brands will clean up.

How is business at All American Pharmaceutical? 

We are growing at a very good rate. Quality is the main thing our clients are looking for. We get a number of inquiries from companies that say – 'I think my manufacturer is cheating me'. When they suspect this, they usually are.

Why do you think so many firms have struggled to get to grips with cGMPs? 

So many manufacturers did not take the new requirements seriously until they were inspected and realized the FDA was going to clamp down. I am not surprised to see the number of warning letters. The cGMP’s are vague and left to interpretation, when the inspectors are in a facility they can always find items that can be improved on.

The scary part is some of the violations that do occur. I believe companies that spend the time and resources to look at their facilities and processes like an inspector or auditor would and just take it off the table will have fewer issues when it comes to compliance.

Based in Billings, Montana, All American Pharmaceutical specializes in producing private label and custom formulations for food and dietary supplement firms. It is also the exclusive manufacturer and patent holders of two branded ingredients: Kre-Alkalyn and Kre-Celezine.

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p-Synephrine shown to be safe

Posted by Bob Green,

With all due respect to Mr. Archer, his comment about synephrine does not reflect the most up-to-date science. A webinar on the topic of “A Safe Alternative to DMAA and Other ‘Problem’ Diet, Fitness, Energy Ingredients” was recently presented by Dr. Sidney Stohs, who reviewed the latest research on the safety and efficacy of p-synephrine. This scientific review - available on-demand at: http://www.naturalproductsinsider.com/webinars/2012/06/safe-alternative-to-dmaa.aspx - clearly indicates that p-synephrine offers an exceedingly wide margin of safety, no regulatory concerns, and can be used safely and effectively alone or in combination with a wide range of other ingredients. – Bob Green, President, Nutratech, Inc.

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Look at science behind Citrus aurantium/p-synephrine

Posted by Sidney J. Stohs, Ph.D., R.Ph.,

The inference by Joe Archer that there is something inherently unsafe about synephrine is not based on current science. p-Synephrine - the predominant amine in Citrus aurantium/bitter orange - is not banned by WADA, the FDA or Health Canada. Health Canada changed its guidelines regarding p-synephrine last year, and it is my understanding that the NFL is reviewing the science and safety behind p synephrine. Extensive research has been published in recent years on the safety and efficacy of Citrus aurantium/bitter orange and p synephrine (http://www.nutratechinc.com/advz/advz.php?p=2). These studies clearly indicate that Citrus aurantium/bitter orange contains p synephrine, which increases thermogenesis and lipolysis, with no cardiovascular effects. p Synephrine should not be confused with m synephrine (phenylephrine), found in nasal decongestants and sprays, which impacts adrenergic receptors, potentially increasing blood pressure and heart rate.

Sidney J. Stohs, Ph.D., R.Ph.
Dean Emeritus, School of Pharmacy and Health Professions
Creighton University, Omaha, Nebraska

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