90% of all companies are contract manufacturers. What this means is that they have no role in the manufacturing of their goods, other than distribution. T hey may have the tablets, capsules or liquids made here in the states or they may be made overseas. Basically you give them a recipe, or buy a batch of pre made formulas. This means they have zero ability to oversee quality control. Or regulate what really gets put into their product. And prior to july of this year companies did not need to double check what was in their product, they could just hand you the manufacturers assay. But I believe Jarrow L. Rogvin, President, Chairman of the Board, Jarrow Formulas, Inc. says it best in a rant for cGMP’s in a response to a blog claiming they will hurt the industry.

Jarrow’s statements can be found here

“First, GMPs. Do you have any idea what they are or what they mean? Obviously not. GMPs are simply a system of quality control. Supplements are actually complicated and that may not seem comprehendible to you but that is your problem, not ours. We actually built a multi-million dollar facility in order to be able to maintain quality control. We simply could not rely any longer on the incompetence, bungling and screw-ups of other companies any longer. We would supply raw material X and direct Z amount to be used. They would put in raw material Y and would put in W, if not Q amount. We would have to destroy the batch when our QC caught the bungling and then would have to demand remanufacturing…but in the meantime lose sales, shelf space, goodwill and freak out from the horror of it all. There was insufficient accountability or reliability. Hence, we spent millions to build Jarrow Industries so Jarrow Formulas’ customers could be certain of the reliability of our products and I wouldn’t have to worry about what new screw-ups would be pulled by outside vendors. And then dolts like you send out hysterical emails that GMPS are the end of the world. No, Byron, GMPs are so my customers can be assured that our products are clean and true-to-claim. And it is actually a lot of work to do that and the customers deserve and I don’t want to compete against companies that deliberately don’t do it.”

Just to be clear, I do not work for Jarrow Formulas. I just happen to respect the man for his passion and his integrity. The current problem is an administration that routinely conducts its regulations in a manner similar to letting the foxes guard the hen house. Until standards are created and enforced that protect us from malicious or criminally negligent manufacturers we have to either hope that we are buying quality products or buy from reputable companies from stores that want to see you healthy.

In regards to how do pharmaceuticals could end up in a dietary supplement, if the plant also manufactures pharmaceuticals, but does not clean it’s equipment appropriately contamination can occur. If they do not quarantine ingredients or assay incoming ingredients contamination may occur. So on and so forth.

just my 2 cents

Andro, norandro etc were covered by DSHEA because you could find them in most animals, and hence in the food supply. No animals, plants, etc naturally produce DMT, Epistane, methyl, 1-4ADD, etc etc.

Are you stating that you believe supplements contaminated with steroids ARE the result of deliberate inclusion by the supplement manufacturer?

You state that “‘Contamination’ is just a pretense, a slight-of-hand to hide their evil and pass the blame.”

But there is quite a bit of evidence suggesting significant percentages of supplements are contaminated with undeclared and/or prohibited steroids and/or stimulants.

See following:

C. Judkins, D. Hall, K. Hoffman. (2007). Investigation into supplement contamination levels in the US Market. Cambridgshire UK: HFL Ltd.

http://www.usatoday.com/sports/hfl-supplement-research-report.pdf

Then there’s the IOC study in April 2002 that revealed 15% (18% in the U.S.) of dietary supplements purchased in various countries contained undeclared steroid and/or prohormone ingredients.

http://www.cyclingnews.com/features/?id=taintedsupplements

Do I think this is solely a quality control problem. Unlikely. There is probably a small number of unethical companies that intentional contaminate or “spike” their products with performance-enhancing drugs. But in large part, it is a quality control issue; I cannot fathom that 20-25% of the industry deliberately contaminate their supplements as you suggest!

http://www.steroidreport.com/2007/12/06/steroids-found-in-popular-dietary-supplements/ ]]> http://www.steroidreport.com/2008/02/06/steroids-and-dietary-supplement-regulation/comment-page-1/#comment-71 SteroidMedia.com Wed, 06 Feb 2008 22:05:50 +0000 http://www.steroidreport.com/2008/02/06/steroids-and-dietary-supplement-regulation/#comment-71 I'm the last person in the world that you need to convince of the health benefits of DHEA; I'm not sure why you feel the need to defend DHEA. I made statements of fact: DHEA is permitted under DSHEA; Pregnolone is permitted under DSHEA. Furthermore, derivatives and precursors of pregnolone are permitted as well so long as they meet other criteria set by DSHEA and not prohibited by Controlled Substance Act. Isn't this correct? (Please answer this question.) I’m the last person in the world that you need to convince of the health benefits of DHEA; I’m not sure why you feel the need to defend DHEA.

I made statements of fact: DHEA is permitted under DSHEA; Pregnolone is permitted under DSHEA.

Furthermore, derivatives and precursors of pregnolone are permitted as well so long as they meet other criteria set by DSHEA and not prohibited by Controlled Substance Act. Isn’t this correct? (Please answer this question.)

You don’t seem to get it: There is not accidental contamination; I believe that it is deliberate use of steroid compounds disguised as dietary supplements. It is like identity theft; yet you blame the victim.

It is not about poor manufacturing; it is about illegal performance drug dealing.

Self regulation is not going to stop cheaters who are already knowingly breaking the law. Instead of blaming the cheats, you are blaming the law and the law-abiding. How can the cheats both be breaking the law and getting away with it because the law allows it (it really doesn’t)? Steroid pushers are knowingly hiding their drugs, which are disguised as dietary supplements. This has nothing to do with legal dietary supplements or the strength of manufacturing rules. “Contamination” is just a pretense, a slight-of-hand to hide their evil and pass the blame.

Show me one example of a dietary supplement that has been accidentally contaminated with an anabolic steroid or precursor ingredient that has been outlawed…it can’t be done, since manufacturers have no business even having illegal controlled substances on premises or dispensing them without prescription.

You also question DHEA, pregnenolone and progesterone. Yet there are millions of Americans using them for legitimate health reasons. Let’s look at DHEA references for use in the general population of mature adults, with a final reference that DHEA has no performance benefits. This shows the folly of trying to treat everyone like elite athletes:

“…at 70-80 years of age, peak DHEAS concentrations are only 10-20% of those in young adults. This age-associated decrease has been termed ‘adrenopause’, and since many age-related disturbances have been reported to begin with the decline of DHEA/DHEAS levels, this provides a potential opportunity for use of DHEA as replacement therapy.” (1)

“DHEA supplementation may be of benefit in two specific groups of women: those with the lowest circulating levels of DHEA; and those for whom osteoporosis is a particular problem.” (2)

“DHEA treatment significantly improved overall wellbeing as well as scores for depression, anxiety, and their physical correlates…In conclusion, DHEA replacement improves well-being … in women with adrenal insufficiency.” (3)

“Adrenal insufficiency is a life-threatening disorder.” (4)

“Available studies have demonstrated beneficial effects of DHEA on health perception, vitality, fatigue…compassionate use of DHEA in individual patients with AI and impaired well-being may be justified.” (5)

“Influenza is particularly dangerous to older people with weakened immune systems. Age-associated DHEA deficiency may be partially responsible for an age-related decline in immune function…Other studies have shown DHEA and its metabolites have powerful immune-enhancing and antiviral effects…DHEA may be a hormone to consider for prevention of colds and flu, particularly in the elderly.” (6)

“Studies have demonstrated repeatedly that acute and long-term administration of these oral … precursors does not effectively increase serum testosterone levels and fails to produce any significant changes in lean body mass, muscle strength, or performance improvement compared with placebo.” (7)

“Likewise, progesterone has numerous uses for women. For others it is a protective substance. In fact, one study showed it cut the death rate by roughly 50% and improved recovery measures for traumatic brain injury survivors.” (8)

“Until the publication of 2 randomized controlled
trials (RCT) on the use of progesterone in 2003,no
other generally effective therapy had been shown to prevent PTB.” [Preterm birth, "responsible for over
70% of perinatal morbidity and mortality, accounting for 20% of children with mental retardation and almost
50% of children with cerebral palsy"]. (9)

“Transdermal estradiol and a twice-weekly administration of the vaginal progesterone gel Crinone constitutes a new, viable hormone replacement therapy regimen. It represents a practical option for a no-bleed treatment, ensuring both high endometrial protection and the inherent safety linked to administrating physiologic hormones nonorally.” (10)

Finally, vitamin D is a steroid hormone, also made from cholesterol like testosterone, so where do we draw the line for adults who want health benefits from steroid compounds and aren’t competitive athletes?

REFERENCES:

1. Genazzani AD, Lanzoni C, Genazzani AR. Might DHEA be considered a beneficial replacement therapy in the elderly? Drugs Aging. 2007;24(3):173-85. Review. PMID: 17362047 [PubMed - indexed for MEDLINE]

2. Raven PW, Hinson JP. Dehydroepiandrosterone (DHEA) and the menopause: an update. Menopause Int. 2007 Jun;13(2):75-8. Review. PMID: 17540138

3. Arlt W, Callies F, Allolio B. DHEA replacement in women with adrenal insufficiency–pharmacokinetics, bioconversion and clinical effects on well-being, sexuality and cognition. Endocr Res. 2000 Nov;26(4):505-11. PMID: 11196420 [PubMed - indexed for MEDLINE]

4. Oki K, Yamane K. Therapies for adrenal insufficiency. Expert Opin Pharmacother. 2007 Jun;8(9):1283-91. Review. PMID: 17563263 [PubMed - indexed for MEDLINE]

5. Allolio B, Arlt W, Hahner S. DHEA: why, when, and how much–DHEA replacement in adrenal insufficiency. Ann Endocrinol (Paris). 2007 Sep;68(4):268-73. Epub 2007 Aug 8. Review. PMID: 17689478

6. Roxas M, Jurenka J. Colds and influenza: a review of diagnosis and conventional, botanical, and nutritional considerations. Altern Med Rev. 2007 Mar;12(1):25-48. Review. PMID: 17397266 [PubMed - indexed for MEDLINE]

7. Smurawa TM, Congeni JA. Testosterone precursors: use and abuse in pediatric athletes. Pediatr Clin North Am. 2007 Aug;54(4):787-96, xii. Northeastern Ohio Universities College of Medicine. PMID: 17723877 [PubMed - indexed for MEDLINE]

8. David W. Wright. ProTECT: A Randomized Clinical Trial of Progesterone for Acute Traumatic Brain Injury. Annals of Emergency Medicine, Volume 49, Issue 4, April 2007, Pages 391-402.e2

9. Ness A, et al. Impact of the recent randomized trials on the use of progesterone to prevent preterm birth: A 2005 follow-up survey. American Journal of Obstetrics and Gynecology, Volume 195, Issue 4, October 2006, Pages 1174-1179.

10. Am J Obstet Gynecol 2002;187:556-60.

The problem in this area is lack of enforcement. But the end result is the same, significant number of supplements have been contaminated with steroids and stimulants.

This is a problem. We can blame the government’s lack of enforcement. Or we can blame the supplement industry poor quality control. But in the end, DSHEA will come under attack, right or wrong, as a consequence.

This is why I think the supplement industry has failed. They have every incentive to self-regulate, prevent supplement contamination, etc. to preserve DSHEA, but are not doing so.

First of all, you are correct in stating that dietary supplements are “regulated”; CNN was incorrect in stating that the industry was “unregulated.”

That is not my point of contention. It is whether or not the regulation that you cite from regulatory websites is meaningful. I believe it is not.

Also, with regard to steroids included in supplements, I am not referring to undeclared ingredients. You are correct this is blatantly prohibited by DSHEA.

No, I am talking about steroid ingredients that have been permitted by DSHEA for over a decade. Let’s not forget that androstenedione, androstenediol, norandrostenediol, etc were once legally permitted. After recognizing the loopholes permitted steroids to be marketed as dietary supplements they made regulatory changes a few years ago.

BUT they still permit steroidal products DHEA and pregnolone. As a result of the latter, steroidal derivatives of progesterone are still permitted (legally and with full blessing of DSHEA) in the marketplace. Is this not correct?

There have been several steroidal products with anabolic properties derived from progesterone that have been commercially available in recent years even after the passage of the Anabolic Steroid Control Act of 2004.