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Old 01-24-2008, 11:38 AM   #1
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Default FDA Announces Plan to Eliminate Vitamin Companies

FDA Announces Plan to Eliminate Vitamin Companies

http://www.newstarget.com/022499.html

Tuesday, January 15, 2008 by: Byron Richards

(NewsTarget) The FDA, emboldened by its transformation into a drug company, has embarked upon an anti-American plan of interfering with business and intentionally eliminating various dietary supplement companies from the market. The FDA announcement came on Friday, June 22, 2007 under the guise of a final rule for dietary supplement good manufacturing practices (CGMPs). Within this 800 page rule the FDA states, "We find that this final rule will have a significant economic impact on a substantial number of small entities... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business... 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business... costs per establishment are proportionally higher for very small than for large establishments... The regulatory costs of this final rule will also discourage new small businesses from entering the industry." (http://www.cfsan.fda.gov/%7Elrd/fr07625a.html)

This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." Thus, the FDA is intentionally seeking to shrink the size of the dietary supplement industry and reduce the influence of safe and effective options to improve the dreadful trend in the health of Americans. The goal is to leave toxic drugs as the primary health option.

Independent analysis of this FDA rule has placed cost of compliance at 10 fold what the FDA estimates with as many as 50% of small companies unable to comply.

The gutless cowards of Congress, a majority of whom are on the Big Pharma payroll or will be on it once they leave Congress, have delegated their lawmaking powers granted by the U.S. Constitution to a bunch of Big Pharma-friendly unelected bureaucrats at the FDA, who are in turn using this power to undermine free commerce and help Big Pharma eliminate competition from the market. This is the behavior of a government in tyranny, inviting a revolution by the people. It is noteworthy that fascist governments of the past have eliminated health freedom and health options as a necessary condition to enslave and brainwash a population (http://www.fee.org/publications/the-...rint_view=true) . Congress has delegated its responsibility to the people to such an extent that over half the laws in this country are now concocted by unelected bureaucrats with vested interests.

A Vehicle for Unprecedented Harassment

Any company that can afford to comply with the costs and regulations of this new FDA rule can be targeted and eliminated at will by the FDA. In essence, the FDA is seeking to make the dietary supplement industry document every phase of production, including expensive testing at multiple points in the production process. Massive record keeping will be required, including all customer complaints and returns for any reason! This is utterly draconian and an unnecessary interference and burden to free commerce. It is completely Anti-American.

No doubt, the FDA will impose user fees as an additional charge so that FDA agents will have the funding required to enforce the regulations. Under the new rule any flaw in bookkeeping can result in a company's products being declared adulterated, allowing the FDA to remove them from the market even though nothing is wrong with them! A company can then be forced out of business because they won't be able to sell any products to raise the money to comply. The rules are so complex and vague that the FDA can selectively target any company it chooses, even those attempting to comply in good faith.

The FDA is doing this under the pretense of improved consumer safety. Consumer safety could readily be guaranteed by simply having all companies test their final products for purity and potency. Instead of this simple approach the FDA has gone to the extreme of burdening the dietary supplement industry with regulations in excess of the drug industry. Supplements are foods, not drugs. The food industry couldn't begin to comply with these FDA rules, even though food contamination is far more dangerous to health than dietary supplements.

The FDA intends to phase this rule in over the next three years. This means that within five years half the industry and many of the health options individuals rely on will either be gone or significantly more expensive.

Even more chilling is that forces within the dietary supplement industry itself are in no small part responsible for this FDA final rule.

Trade Groups and their Big Companies Turn on America

The Natural Products Association (formerly the National Nutritional Food Association – NNFA) and the Council for Responsible Nutrition (CRN) have been instrumental in forcing these drug-like rules on dietary supplements. These globalist organizations are selling out America, destroying American jobs, undermining the U.S. Constitution, and working in conjunction with pharmaceutical companies to usher in Codex and the New World Order. Consumers of dietary supplements should learn who these companies are before buying their products and helping to inadvertently fund the destruction of health freedom in this country.

When DSHEA was passed in 1994 part of that law required the FDA to establish current good manufacturing practices (CGMPs) for the dietary supplement industry. During a period of FDA outreach to the industry the FDA was surprised to learn that CRN and NPA were in favor of drug-like CGMPs for the dietary supplement industry. These trade groups, working closely with Senators Orin Hatch (R-UT) and Tom Harkin (D-IA), have intentionally taken the supplement industry down a slippery slope. It is noteworthy that Hatch takes in more money from Big Pharma than he does from dietary supplement companies. Not only is Hatch a big supporter of the Medicare Part D drug rip off of Americans he has saved Big Pharma billions by protecting them from generic competition, as he is currently attempting to do with his legislation for new biologic drugs. Hatch also has a son working for NPA and another son that lobbies for NPA and the dietary supplement industry. When Hatch leaves the Senate he will be first in line for a six or seven figure Big Pharma salary.

The CRN has been taken over by multinational drug and food companies. Key players are the nutritional divisions of Bayer, BASF, Cargill, Monsanto, Wyeth, and Archer Daniels Midland (http://www.crnusa.org/who_omc.html). Nutrition companies that participate are in most cases owned by pharmaceutical companies, heavily invested in pharmaceutical companies, or jockeying for position in the international market as part of the New World Order. Key names include Mannatech, Shacklee, Herbalife, GNLD International, The Vitamin Shoppe, and GNC. These companies are glad to eliminate competition from small companies and start up ventures.

Carrying on the general theme of Big Pharma ownership and a globalist agenda are the companies that control the NPA. One need only look at the new NPA China board to understand who these key players are (http://www.naturalproductsassoc.org/...name=abt_China) . Jarrow Formulas, Now Foods, GNC, and Herbalife top the list. At the end of 2006 Jarrow and Now helped lead the charge with Senators Hatch and Harkin to burden the dietary supplement industry with bizarre Adverse Event Reporting legislation (AER) which insisted that dietary supplement companies keep extensive records on any type of consumer complaint. Aspects of this AER law are now implemented in the FDA final rule on CGMPs. Of course, NPA was quick to offer expensive training to its members to indoctrinate them into how to comply with the rules that NPA, working on behalf of the FDA, just forced on its own members. Are their member companies really this stupid? Or are they all working together? I would recommend that any NPA member that believes itself to be a true American company that values our constitution immediately withdraw from NPA membership – consumers will be looking to see who you are (http://www.naturalproductsassoc.org/...name=abt_Board) .

The picture is now crystal clear for any person who cares to look. Numerous dietary supplement companies are anti-American and actively selling out our country and our constitution, working hand-in-glove with the FDA and Big Pharma. The majority of such companies can be found as members of CRN and NPA. It will be up to the American consumer to save the dietary industry from itself and preserve their own access to safe and effective natural health remedies. This is a relatively simple task. Quit buying products from or quit being a distributor in these fascist organizations. Support the small companies that are the backbone of America, otherwise they will soon be extinct.

Update on S.1082 Threat to Dietary Supplements

Many of you have been following the extreme threat to dietary supplements posed by S.1082 (http://www.wellnessresources.com/health_freedom.php) . Similar legislation has now cleared the House Energy and Commerce Committee and is headed for the floor of the House in the next week or two. The House version of this bill now contains the "food and food ingredients" language that the FDA can use to apply drug-related risk/benefit analysis to dietary supplements and have them removed from the market at their whim.

It is noteworthy that both CRN and NPA have posted on their websites information stating that S.1082 is not a threat to dietary supplements. Both organizations are flat out wrong. They cite a colloquy by Hatch, Harkin, Kennedy, and Enzi as their evidence. This colloquy was a direct result of our grassroots campaign to alert the American consumer to this major threat. In no way does this colloquy protect dietary supplements. Until the language in the bill is changed the threat exists and is very real. CRN and NPA also tell their members that the Codex initiative to scare consumers into thinking that dietary supplements are unsafe above minuscule amounts and need to be regulated by international laws is also no big deal. It is clear that CRN and NPA, again working hand-in-glove with the FDA, are a major part of the problem and are actively engaged in forwarding the globalist agenda of the New World Order. While pretending to represent the dietary supplement industry these organizations are in fact shooting the industry in the back and undermining health options for Americans.

The FDA is Out of Control

The FDA is a tyrannical organization that is now emboldened and completely out of control. It is not surprising that the FDA is seeking to eliminate competition to Big Pharma, they have been doing that for much of the past century. What is surprising is that they are openly stating in their final rule a plan that directly eliminates small businesses from existence. This fascist organization believes itself to be above the rule of law and is actively working against America and the rights of Americans (http://www.emord.com/events/speeches/fda_violation.htm) . It must be stopped.


About the author
Byron J. Richards, Founder/Director of Wellness Resources (www.wellnessresources.com), is a Board-Certified Clinical Nutritionist, a charter professional member of the International and American Associations of Clinical Nutritionists (IAACN) since 1991. He is a nationally-renowned health expert, radio personality, and educator. He is the creator and pioneer of The Leptin Diet® and has been a featured expert consultant on Fox News Live, CBS Infinity television (national syndication), and The Wall Street Journal. Richards has appeared on hundreds of radio programs throughout the country. He is the author of Mastering Leptin (http://www.wellnessresources.com/pro...ing_leptin.php), The Leptin Diet (www.wellnessresources.com/Books/leptin_diet.php), and Fight for Your Health: Exposing the FDA's Betrayal of America(http://www.wellnessresources.com/Boo...our_health.php).
Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. As founder of Wellness Resources, Inc. of Minneapolis, MN, an independently-owned nutraceutical-quality dietary supplement company since 1985. He has personally developed 75 effective nutritional formulations. (www.wellnessresources.com)
FREE Subscription to Byron's Health Newsletter, click here(www.wellnessresources.com/store/newsletter.php)
E-mail: byron@wellnessresources.com
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Old 01-24-2008, 12:49 PM   #2
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Wow. That's an unbiased piece of reporting.
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Old 01-25-2008, 12:22 PM   #3
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This is not my report, i just happen to run across this.
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Old 01-25-2008, 12:36 PM   #4
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I didn't say it was My reaction is only about the article writer, not the poster.

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Old 02-03-2008, 01:09 PM   #5
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Funny how the FDA want to put vitamin companies out of business but condone the use of GH in our livestock.
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Old 02-03-2008, 05:01 PM   #6
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That would be the USDA. FDA has nothing to do with food from livestock, etc..

This guy who wrote that has been sent at least one warning letter by the FDA for making ridiculous claims about some sup he sells. Telling people it would treat or cure their fibromialgia. Of course he doesn't like the FDA. They are not going to allow him to make money by victimising suffering people with bullshit miracle cures. Consider the source. The FDA has problems but don't think everybody who writes an article like this is some type of angel looking out for your interest. Just another guy looking to take your money if he can. The article is heavily slanted toward his agenda. Sup companies should be accoutable for what they do, what they claim, etc. just like the food idustry is supposed to be accountable.

Sorry, but people are way gullible and trusting when it comes to this stuff. Half the shit you buy doesn't even meat the label claims. It's one thing for people to be responsibe for their own decisions, but it won't do them any good when those decisions are based on false and misleading information. If a sup company buys a bunch of bulk crap from china and then throws it into a sup, damn right, they should be keeping records of everything. Half the crap could be contaminated with whatever. Most people read the labels of the food they buy but most people don't have a clue what's in all the pills they take. It's ridiculous.

It's gotten ridiculous with American companies not taking any responsibility for the things they market. You got toys coming from china that either kills kids or makes them sick. Kills them! But it's an American company selling it. THEY are responsible. Just as responsible as the government and the suppliers or manufacturers who take shortcuts. I heard some candidate saying the solution is to "buy American". Idiot. Most of the crap we buy is from an American company...it's just not made here. But I digress...

You'd think the dietary sup industry was so essential we'd all be dead without it. If half the stuff on the market is gone tommorow...guess what, most of it was snake oil anyway, lol. People are virtually throwing away money on "health options" that if they "depend" on them it is mostly in their minds. Sure there is some good stuff but you think we really need "colloidal silver" claiming to cure every illness known to man, or "oxygen supplements" likewise? Half of which is probably poison to your body if not just worthless. If the sup industry takes a hit and if some prices go up, I think we'll all survive. You will still be able to get your multi-vit/min and fish oil and stuff like that, lol. Oh, and whey

Frankly, I don't care. If the food and drug industry...things you put in your body...is subject to good manufacturing guidelines then so should the "dietary sup" industry. This whole claim that "we are already safer and our crap doesn't stink like the evil food and drug industries" to me, is not very convincing. The fact is, I have emailed many comps about their claims and asked for proof of quality. Lots and lots. Most of the time I have gotten a standard answer: "I have referred your question to management". And then nothing. Put your money where your mouth is.

I do want to point out, in all earnestness, that this is not me being on a tirade against sup companies. On the contrary, I have some standards that I trust explicitly. And more importantly it has been DIETARY SUP COMPS and other members of the industry that have for YEARS been urging the FDA to get to this and have voluntarily submitted proposals to that effect. Also, the article didn't mention that these smaller companies were given longer to comply. Less that 500 but more that twenty employees, 2009. Less than 20, 2010. I forget the exact dates.

I'll bet it helps companies anyway. It's doubtful that the FDA will enforce all of it with any kind of real effectiveness. There are lots of loopholes and gray areas. And it will just be something companies can hide behind saying "we have to be good, the FDA makes us".

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If you act sanctimonious I will just list out your logical fallacies until you get pissed off and spew blasphemous remarks.
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Old 02-04-2008, 04:00 PM   #7
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Right on
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Old 02-04-2008, 04:06 PM   #8
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Which part
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Old 02-06-2008, 12:31 PM   #9
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Right.

Anyway I thought I'd go ahead and provide a little back up to why this guy might have a grudge:

December 27, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Byron J. Richards, President
Wellness Resources, Inc.
7155 Amundson Ave
Edina, MN 55439

Ref. No. MIN-06-16
Dear Mr Richards:
The Food and Drug Administration (FDA) inspected your firm located at 7155 Amundson Ave, Edina, MN, on May 18-19 and June 7, 2005. During the inspection our investigator collected labeling for your products, including product labels, literature available to customers on your premises and literature included in product shipments. In addition, we reviewed your website at the Internet address www.wellnessresources.com. Our review of the labeling collected during the inspection and provided on your website identified the following violations of the Federal Food, Drug, and Cosmetic Act (the Act):
Dietary Supplements Without Iron Statement:

Your products Blood Builder and Super Mini-Multi Children's MultiVitarnin are misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 USC 343(a)(1) and 21 USC 321(n)] because the labels for these products, which contain added iron, fail to bear the following warning statement as required by Title 21, Code of Federal Regulations 101.17(e) [21 CFR 101.17(e)]:
"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."
Dietary Supplements Without Psyllium Husk Statement:

Your product Fiber Helper™ is misbranded within the meaning of sections 403(a)(1) and 201(n) of the Act [21 USC 343(a)(1) and 21 USC 321(n)]. Your labeling for this product, which contains psyllium seed husk, bears a health claim on the association between soluble fiber from psyllium seed husk and reduced risk of coronary heart disease. However, the label for this product fails to bear a label statement, as required by 21 CFR 101.17(f), informing consumers that the appropriate use of such foods requires consumption with adequate amounts of fluids, alerting them of potential consequences of failing to follow usage recommendations, and informing persons with swallowing difficulties to avoid consumption of the product.
Disease Claims:

Under section 201(g) (1) (B) of the Act [21 USC 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease are drugs. Claims that appear on your product labels, in product literature that you distribute to customers, and on your website at www.wellnessresources.com promote some of your products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)). The claims establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of disease claims observed in your products' labeling, including your website, product labels, and product literature include:
  • Black Currant Oil
    • From your website:
      • "Helps reduce inflammation and pain."
      • "High potency anti-inflammatory oil, may help reduce pain of any type, especially ongoing/chronic pain"
      • "Proven in several clinical trials to reduce the pain and symptoms of rheumatoid arthritis"
    • From the label:
      • "It is a safe and effective natural anti-inflammatory. It has been proven to reduce joint pain…"
    • From literature:
      • "Helps regulate inflammation and reduce arthritic pain. Also helps lower blood pressure.Ó
      • "Proven in clinical trails to reduce the pain of rheumatoid arthritis."
  • Calcium-AEP
    • From your website:
      • "Excellent product for low back pain, hip pain (sciatica), jaw pain (TMJ), or any dental pain/problem"
      • "Strengthens a weakened nervous system; especially helpful for problems of nerve exhaustion such as depression or fibromyalgia."
      • "Helps nerves handle pain better so that healing can occur more readily, generally helps reduce any type of pain, including chronic or acute pain"
    • From literature:
      • [Under the heading Depression] "Heals inflamed nerve tissue…"
      • [Under the heading Healing and Repair] "Reduces pain to speed healing."
      • [Under the heading Neuropathy] "Heals the myelin sheathing of nerves…"
      • [Under the heading Pain Reduction] "The best single product for low back pain, sciatica, hip pain, jaw pain and dental pain."
  • Tri-Cal
    • From your website:
      • "Helps … lower cholesterol by enhancing the formation and flow of bile…"
  • Cardio Helper
    • From your website:
      • "Helps lower high blood pressure"
      • "Helps stabilize irregular heart beats…"
      • "It can be used with or without any cardiovascular medication (except digoxin/digitalis — as it has an opposite effect; i.e., digoxin may cause arrhythmias whereas Hawthorne gets rid of them)."
    • From literature:
      • "[L]owers BP."
    • From the label:
      • "It may also help reduce blood pressure by improving electrolyte status and lymphatic function."
  • Chondroitin Plus
    • From your website:
      • "Helps prevent migraine headaches"
      • "We also add high potency feverfew, a proven herb for arthritic pain and migraine headache prevention."
    • From literature:
      • "Reduces arthritic pain."
      • "Helps prevent headaches."
      • [Under the heading Headaches] "Contains a high level of feverfew that can prevent headaches."
      • [Under the heading Healing and Repair] "[R]educes pain."
  • Super CLA
    • From your website:
      • "Reduces hypoglycemia, helps prevent diabetes"
      • "CLA has been known about since the 1940s, but nutritional interest began when researchers at the University of Wisconsin were looking for compounds in cooked meat that could cause cancer. Much to their delight, they stumbled onto a compound in cooked meat that could possibly prevent cancer … [T]hey were able to determine that this compound was CLA."
      • "Recent research has shown that CLA can help prevent hypoglycemia by helping to correct insulin sensitivity (making it so that blood sugar can enter cells correctly) … The scientists were so excited about the ability of CLA to fix impaired glucose tolerance that they concluded CLA may prove to be an important therapy for the prevention and treatment of diabetes."
    • From literature:
      • [Under the heading Cancer Risk Reduction and Support] "Higher amounts of CLA in breast tissue may reduce breast cancer risk."
  • Colloidal Silver
    • From literature:
      • [Under the heading Immune System Protection] "A powerful natural and non-toxic germicidal and anti-viral product."
  • Daily Balancer™
    • From your website:
      • "Prevents and possibly reverses mutagenic cell changes"
      • "Helps fibromyalgia and chronic fatigue syndrome"
    • From literature:
      • [Under the heading Cancer Risk Reduction and Support] "Reduces liver inflammation and protects the liver from damage."
      • [Under the heading Detoxification and Liver Support] "[H]elps headaches and toxic fatigue."
      • [Under the heading Fibromyalgia] "Clears headaches…"
  • Daily Protector
    • From your website:
      • "Helps prevent macular degeneration…"
    • From literature:
      • "Protects eyes, skin, reproductive organs, and all cells from mutagenic free radical damage."
      • "High amounts of lycopene, proven to reduce prostate-cancer risk."
      • "Contains synergistic carotenes, flavonoids, and cofactors that make up for a lacking diet-all of which reduce male cancer risk."
  • Daily Super E
    • From your website:
      • "Most effective natural compound known for lowering high cholesterol…"
      • "Has demonstrated a reversal of plaque build-up in arteries in individuals with significant health problems."
      • "Highly effective for preventing platelet aggregation, more effective than aspirin."
    • From literature:
      • [Under the heading Cancer Risk Reduction and Support] ÒTocotrienols that have been shown to reduce breast cancer risk."
  • Fiber Plus
    • From your website:
      • "Helps lower cholesterol…"
      • "Helps prevent hypoglycemia…"
      • "Helps reduce colon cancer risk"
  • Gluco Plus
    • From your website:
      • "Prevents hypoglycemia"
      • "Lowers triglycerides and LDL cholesterol…"
      • "Excellent nutritional support for anyone who is diabetic or had pre-diabetic metabolic problems"
      • "[H]elps prevent glaucoma"
    • From literature:
      • [Under the heading Sugar Cravings/ Regulating Blood Sugar] "[H]elps reduce high blood sugar levels."
  • Immune Plus
    • From your website:
      • "Helps clear body aches associated with illness, allergy, or fibromyalgia"
      • "Has natural 'vaccine like' properties…"
      • "Very effective at preventing and helping to clear ear infections"
      • "Helps bring down a fever (use high doses)"
    • From literature:
      • [Under the heading Allergies and Congestion] "Clears congestion and mucous, preventing the lymph system from getting overloaded."
      • [Under the heading Cancer Risk Reduction and Support] "[E]xcellent for reducing breast pain."
      • [Under the heading Immune System Protection] "Helps prevent germs from 'sticking,' enhances germ surveillance."
  • Leptinal™ — The Lentin Helper™
    • From your website:
      • "Helps lower blood pressure and lower LDL cholesterol"
    • From literature:
      • [Under the heading Arthritis] "Anti-inflammatory formula."
      • [Under the heading Cancer Risk Reduction and Support] "Reduces inflammation signals linked to obesity that increase cancer risk."
  • MONOLAURIN
    • From the label:
      • "[T]his product is a specially prepared monoglyceride that has been scientifically demonstrated to have a wide range of antiviral, antibacterial, and antifungal activity."
  • RelaxaMag (formerly called Tri Mag)
    • From your website:
      • "Helps lower blood pressure by relaxing the vascular system…"
      • "Helps stop or prevent tension headaches…"
    • From literature:
      • [Under the heading Cholesterol] "Unique magnesium to help lower cholesterol and prevent plague."
    • From your label (for Tri-Mag):
      • "[H]elps lower blood pressure and supports a more stable heart rhythm."
  • Oregano oil
    • From your website:
      • "A Powerful Anti-Fungal"
      • "An All Purpose Anti-Bacterial"
      • "Capsules may be opened and applied topically to any skin problem /infection."
    • From literature:
      • [Under the heading Acne] "Kills bacteria and yeast…"
      • [Under the heading Allergies and Congestion] "Helps clear sinus infection and congestion."
      • [Under the heading Candida] "Strong anti-fungal oil; fights sinus infections."
      • [Under the heading Immune System Protection] "Powerful broad spectrum antiseptic.
      • [Under the heading Lymphatic Congestion] "[H]elps clear infection from lymph."
  • Pantethine
    • From your website:
      • "Reduces LDL cholesterol and triglycerides, … and protects against hardening of the arteries"
      • "Protects against the formation of cataracts"
  • Performa Plus™
    • From your website:
      • "Helps lower blood pressure."
    • From the label:
      • "The nutrients in Performa Plus™ are designed to restore natural balance in the production of nitric oxide (NO). … Enhancing NO formation is beneficial for … helping to reduce blood pressure if it is high."
  • Preventor Plus™
    • From your website:
      • "Helps correct hormone imbalances for women and men that otherwise increase cancer risk."
      • "Improves cellular health to help all cells have more resistance to mutation and DNA damage."
      • "Directly interferes with the cellular reproduction of cancer cells as well as directly inducing the death of cancer cells."
    • From the label:
      • "Preventor Plus contains nutrients that help prevent the improper metabolism of estrogen and testosterone. Improper metabolism of sex hormones can increase the risk for developing hormone related cancer."
    • From literature:
      • [Under the heading Cancer Risk Reduction and Support] "Reduces hormone imbalance that initiates and/or perpetuates problems."
  • Super CoQ10
    • From your website:
      • "Numerous cardiovascular studies have shown that Q10 can help high blood pressure, congestive heart failure, cardiomyopathy, angina, irregular heart beat, and mitral valve prolapse."
  • Quercetin
    • From your website:
      • "Helps asthma"
      • "Reduces breast cancer risk and helps prevent a reoccurrence of breast cancer"
    • From literature:
      • [Under the heading "Allergies and Congestion] "Very effective antihistamine and anti-allergen."
      • [Under the heading Cancer Risk Reduction and Support] "More effective than Tomoxifen [sic] at binding to EBS type II receptors in breast tissue."
  • Repair Plus
    • From your website:
      • "[H]elps reduce cholesterol"
      • "[H]elps asthma…"
      • "[H)as anti-mutagenic properties"
    • From literature:
      • [Under the heading Arthritis] "Powerful nutritional anti-inflammatory that speeds healing and reduces pain."
      • [Under the heading Healing and Repair) "Powerful anti-inflammatory that reduces swelling and pain and speeds healing."
  • Saw Palmetto
    • From your website:
      • "Reduces Enlarged Prostate (BPH)"
      • "Prevents Prostate Enlargement"
  • Stress Helper™
    • From your website:
      • "Lowers elevated LDL cholesterol…"
  • Super EFA
    • From your website:
      • "Reduces plaquing of arteries"
      • "[H]elps reduce high blood pressure"
      • "[H]elps keep blood cells from inappropriately sticking together"
  • Super Immune Booster
    • From your website:
      • "Use for prevention, especially during the bug season or when around ill individuals."
    • From the label:
      • "Individuals with weak immunity can use it preventatively (sic) during the bug season or an a regular basis to help overcome chronic low grade issues."
    • From literature:
      • [Under the heading Blood Pressure] "Olive leaf extract lowers BP"
      • [Under the heading Candida] "Clears intestinal tract yeast."
      • [Under the heading Sleep: Restorative Sleep] "[R]educes blood pressure."
  • Tea Tree Oil
    • From literature:
      • "Topical antiseptic oil"
    • From the label:
      • "Antiseptic"
      • "Pharmaceutical grade Tea Tree Oil containing 40% Terpinen-4-ol, the highest concentration of active antiseptic ingredient.…"
      • "Use topically for minor cuts/scrapes, nail fungus, insect bites, stings, and minor burns."
  • Thyroid Helper™
    • From your website:
      • "Lowers LDL cholesterol…"
Structure/Function Claims:

Under section 201(g)(1)(C) of the Act [21 USC 321 (g)(1)(C)], articles (other than food, including dietary supplements] intended to affect the structure or any function of the body of man are drugs. Claims that appear on your product labeling, including literature that you distribute to customers, promote some of your products for conditions that cause the products to be drugs under section 201(g)(1)(C) of the Act [21 USC 321(g)(1)(C)]. The claims establish that the products are drugs because they are intended to affect the structure or function of the body. Examples Of structure/ function claims found in literature for your topical products include:
  • Femme Balance Moisture Treatment Crème
    [Under the heading "Balance Female Hormones"]
    • "Weight Loss Tip #14-Imbalances in female hormones lead to stuck issues regarding weight loss if not managed properly."
    • "Controls hot flashes and other menstrual symptoms."
    • "Helps build new bone and prevent bone loss."
    • "The most effective form of estrogen for protecting the brain, helps memory."
    • "Helps bladder incontinence."
    • "Helps vaginal dryness and atrophy."
    • "Femme Balance contains natural estriol and progesterone for female hormone balance and support."
    [Under the heading "Steps to Effectively Build Bone and Prevent Bone Loss!"]
    • "femme balance … Estriol, … has been shown to enhance bone density in older women."
  • Pro Femme Natural Body Cream for Women
    [Under the heading "Balance Female Hormones"]
    • "Weight Loss Tip #14 — Imbalances in female hormones lead to stuck issues regarding weight loss if not managed properly."
    • "Controls hot flashes and other menstrual symptoms."
    • "Helps build new' bone and prevent bone loss."
    • "Hormonal support for improving HDL cholesterol."
    • "Helps symptoms associated with PMS, especially headaches, depression, irritability, mood swings, fluid retention, or bloating."
    • "Helps problems of estrogen dominance: breast swelling and tenderness, fibrocystic breasts, uterine fibroids, endometriosis, or heavy menstruation."
The disease claims and structure/function claims on your product labeling cause your products to be drugs, as defined in sections 201(g)(1)(B) and 201(g)(1)(C) of the Act [21 USC 321(g)(1)(B) and (C)]. Because the products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p)) of the Act [21 USC 321(p)]. Under section 505(a) of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA) [21 USC 355(a)].
Furthermore, the labeling for a number of your products [Black Currant Oil, Calcium- AEP, Tri-Cal, Cardio-Helper, Super CLA, Colloidal Silver, Daily Balancer™, Daily Super E, Fiber Plus, Gluco Plus, Immune Plus, Leptinal™, Monolaurin, RelaxaMag (formerly Tri-Mag), Oregano Oil, Pantethine, Performa Plus™, Preventor Plus™, Super CoQ 10, Quercetin, Repair Plus, Saw Palmetto, Stress Helper™, Super EFA, Super Immune Booster, Thyroid Helper™, and Pro Femme Natural Body Cream for Women] indicates that they are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. These products are misbranded under section 502(f)(1) of the Act [21 USC 352(f)(1)] in that the labeling does not bear adequate directions for use.
Other Labeling Deviations:

Your products Activator Plus and Repair Plus are misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act [21 USC 343(1)(1) and 343(s)(2)(B)] because the labels fail to identify the product with the term "dietary supplement" (or an appropriate alternative) as part of the statement of identity on the principal display panel, as specified in 21 CFR 101.3(d) and 21 CFR 101.3(g).
We request that you take prompt action to correct these violations. Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct these violations, including any steps taken with violative products currently in the marketplace, and an explanation of each step taken to ensure that violations do not recur. Also include copies of any available documentation demonstrating that your corrections have been made. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Failure to immediately cease distribution of your violative products could result in enforcement action by FDA without further notice. The Act provides for the seizure of illegal products and injunctions against the manufacturers and/or distributors of violative products.
In addition to the violations described above, FDA has the following comments concerning the labeling of your products.
The following statements are made on the labels for your products Fiber Plus and Fiber Helper™: "Wellness Resources Fiber Plus [Fiber Helper] does not contain: … oats…" However, the nutrition labeling (Supplement Facts) for your products Fiber Plus and Fiber Plus declares that they contain oat fiber (Avena sativa) and Oat bran concentrate (standardized to contain 54% oat beta glucan), respectively.
If you intend to market your products as dietary supplements (for example, Oregano Oil), please be aware that you must meet the statutory requirements found in section 201(ff) of the Act [21 USC 321(f). In particular, section 201(ff)(2) of the Act requires that dietary supplements be in a form that is intended for ingestion (e.g., tablet, capsule, liquid form etc.). Your website includes directions of use for topical application of Oregano Oil.
This letter is not intended to be an all inclusive review of your products and labeling. It is your responsibility, as president, to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You can find the Act and FDA's regulations through links on FDA's Internet website at www.fda.gov.
Your reply should be directed to Compliance Officer Brian D. Garthwaite, PhD, at the address indicated on the letterhead.
Sincerely,
/s/
W. Charles Becoat
District Director
This page was posted on March 28, 2006.
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Old 02-06-2008, 01:18 PM   #10
EricT
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Don't get me wrong. I am all about alternative medicine. And self-education, research, and using all available info to make decisions with. I personally can't stand Stephan Barret and people like that. BUT I believe that someone purvaying these type of things should try to provide just the factual information and not leap to wide ranging and unsubstantiated claims that have no real basis of support. Provide the info, give access to more, and let people decide for themselves.
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