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Old 06-18-2012, 05:45 AM
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Default Supplement news around the world

Random current news I come across on the net about supplements.

Opinions and content of news articles do not reflect the opinions of Thermolife.com.

This is just a random news blog that I will post what I find interesting, and may or may not agree with.

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The supplement industry's biggest little problem: magnesium stearate


by Connor Link in New Hope 360 Blog

The common supplement filler magnesium stearate could be stricken from the Codex Alimentarius list of food additives. What would this mean for an industry dependent on excipients?

With the constant drumbeat of GMP violations, FTC enforcement actions, scientific discrediting, negative supplement studies and the specter of NDI regulation, the supplement industry has plenty to worry about. But let’s go ahead and let another hornet into the house: magnesium stearate.

A nonpareil in the excipient world, magnesium stearate (or magnesium salt) is an inactive filler used widely in supplement tableting and encapsulation. Because of its lubricating properties, magnesium stearate is especially useful in manufacturing because it keeps ingredients from sticking to equipment during compression and mixing. Lacking an effective alternative, the excipient is nearly ubiquitous in supplement manufacturing.


But, according to a subcommittee of Codex Alimentarius—the world authority on international food standards—magnesium stearate has no known use in food, despite its lengthy history of use in supplements.

(Take a deep breath—prepare for acronyms.) A report from the Electronic Working Group (EWG) of the International Numbering System (INS) submitted to the 42nd Session of the Codex Committee on Food Additives (CCFA) in March 2010 recommended that “magnesium salts of fatty acids” be deleted from the Codex for no known use.

The potential impact would be deleterious to a supplement industry dependent on the excipients. So, a year later, (heads up—more acronyms) the International Alliance of Dietary Supplement Associations (IADSA) submitted a request to the 43rd Session of the CCFA in March 2011 that magnesium stearate be reinstated as a food additive—which it was, under INS number 470(iii).

However, (not out of the woods yet) the Joint Expert Committee on Food Additives (JECFA) now requires toxicity data to substantiate magnesium stearate’s new standing, despite its existing history of use in supplements. According to John Venardos, senior vice president of regulatory affairs for the global network marketing company Herbalife, who presented this issue at the recent NIA West conference in Laguna Beach, the estimated cost of this tox data on magnesium stearate would cost $180,000. No manufacturer has yet volunteered to foot the bill.

Without a favorable opinion from JECFA, however, use of the ingredient could be discontinued.

Some manufacturers may smile at magnesium stearate’s peril. Hypoallergenic supplement companies—such as Thorne Research or Pure Encapsulations—call out their lack of fillers, binders and excipients as a point of differentiation.

But most large-scale manufacturers would likely be scrambling were this ingredient to hit the skids.

What say you, manufacturers? Is there a viable alternative to magnesium stearate?

The supplement industry's biggest little problem: magnesium stearate | New Hope 360 Blog
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JUSTICE IS COMING....

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Old 06-19-2012, 06:28 AM
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California judge allows DMAA class action v Nutrex Research to proceed

A class action lawsuit filed against Nutrex Research over the safety and regulatory status of supplements containing DMAA (1,3-Dimethylamylamine) has been given the green light to proceed by a judge in California.

http://www.nutraingredients-usa.com/Regulation/California-judge-allows-DMAA-class-action-v-Nutrex-Research-to-proceed
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Old 07-13-2012, 05:23 AM
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US senators “deeply concerned” over supplements industry standards

http://www.ingredientsnetwork.com
13 July 2012

Two prominent US senators have called on the supplements industry to state their plans to improve manufacturing conditions in the $28 billion industry.

Senators Dick Durbin and Richard Blumenthal have sent letters to the heads of the Council for Responsible Nutrition, the American Herbal Products Association and the Natural Products Association after raising serious concerns about standards.

“We are deeply concerned about the poor manufacturing standards that expose consumers to potentially serious health risks," said Durbin and Blumenthal.

"Consumers should have access to dietary supplements that meet fundamental quality controls."

Last month, The Chicago Tribune reported that a US Food and Drug Administration (FDA) inspection of 450 supplements firms found violations in over half. One in four companies received a warning letter from the agency and Dan Fabricant, the FDA’s head of dietary supplement programs described the results as “downright scary”.

Durbin and Blumenthal added in their letter that many of the contraventions were “basic, common sense safety practices that should not require regulatory guidance in the first place”.

John Shaw, the Natural Products Association’s executive director acknowledged the seriousness of the issue but questioned the evidence on which the concerns were raised.

“Like the senators, we’re concerned any time a violation may be found with a supplement manufacturer and it’s an issue we take seriously,” he said.

“It’s important to emphasise that dietary supplements are part of a fully-regulated industry and good manufacturing practices apply to all supplement manufacturers, large or small.”

"Supplements have an excellent safety record and we appreciate this opportunity to provide more information to the senators. While we appreciate any concerns the senators may have, reopening a closed debate based on distorted facts causes our members concern, as they work to ensure that consumers get the high quality products they expect and deserve."

"While I am concerned that there are pockets of the industry that have their heads stuck in the sand, these pockets are not representative of the industry,” added Steve Mister, the Council for Responsible Nutrition’s president and chief executive.

The American Herbal Products Association confirmed that it would publish a detailed formal response to the letter shortly.

US senators
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Old 07-13-2012, 09:32 AM
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They need to be more concerned about what money the waste our tax dollars on stupid fucks
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Old 07-13-2012, 12:01 PM
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Quote:
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They need to be more concerned about what money the waste our tax dollars on stupid fucks
Ha...and turn themselves in? lol
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Old 07-14-2012, 05:18 AM
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Pressure mounts on USPLabs as another peer-reviewed paper concludes DMAA is NOT in geranium

If last month’s paper in the Journal of Analytical Toxicology was seen by some observers as the ‘final nail in DMAA’s coffin’, a new paper published in Drug Testing and Analysis this month appears to drive that nail home.

http://www.nutraingredients-usa.com/Research/Pressure-mounts-on-USPLabs-as-another-peer-reviewed-paper-concludes-DMAA-is-NOT-in-geranium
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JUSTICE IS COMING....

Last edited by KimJong-il; 07-14-2012 at 05:23 AM.
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Old 07-18-2012, 07:18 AM
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FDA injunction could mothball US supplements firm

17 July 2012

New York firm Kabco could be suspended from making and distributing supplements after the US Food and Drug Administration (FDA) issued an injunction over alleged breaches of the Federal Food, Drug and Cosmetic Act and Current Good Manufacturing Practice (CGMP).

The FDA, which has recently taken a harder enforcement line on non-compliance and proclaimed CGMP to be the most serious issue facing the industry, first issued a warning letter to Kabco in 2010. The letter identified CGMP non-compliance in manufacturing, packaging and storage of supplements.

According to the FDA, Kabco failed to investigate and rectify the failures, prompting the injunction action.

If the FDA is successful in securing the injunction at the U.S. District Court for the Eastern District of New York , Kabco will be banned from making and distributing its portfolio of supplements until the company can prove that it is complicit with legal standards. Kabco’s current product mix includes Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hips Time Released Tablets and Joint All Capsules.

Neither Kabco nor the firm’s owner Abu Kabir have not commented on the FDA’s

The FDA has dramatically increased its annual number of CGMP inspections from 7 in 2008 to 84 in 2010. The regulator is set to further increase the number of CGMP investigations in 2012.

Source: FDA injunction could mothball US supplements firm - News-content | Ingredients Network | Food Ingredients news powered by Fi & Hi Europe
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Old 07-19-2012, 06:08 AM
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Supplements industry injects $4.5bn into Romney presidential campaign

19 July 2012

Nutritional and dietary supplements firms have funded Republican candidate Mit Romney’s US presidential campaign to the tune of $4.5 billion.

The funding comes at a time when the industry is in disagreement with the Food and Drug Administration (FDA) over plans to introduce more stringent regulation of dietary supplements.

Unlike the pharmaceutical industry, supplements firms are currently exempt from federal review of product safety and effectiveness before they are marketed.

The industry has faced a wave of political pressure to improve standards recently.

Earlier this month, Senators Dick Durbin and Richard Blumenthal said that they were “deeply concerned about the poor manufacturing standards that expose consumers to potentially serious health risks" and called for the $28 billion industry to state their plans to improve conditions.

Trade associations including the Natural Products Association and Council for Responsible Nutrition defended the safety record and ethical standards of the vast majority of the industry.

Supplements industry injects $4.5bn into Romney presidential campaign - News-content | Ingredients Network | Food Ingredients news powered by Fi & Hi Europe
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Old 07-25-2012, 06:16 AM
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UK cracks down on adulterated sports performance supplements

Jul. 23, 2012 by Nancy Coulter-Parker in New Hope 360 Blog


With the opening of the London Olympics just days away, the UK is stepping up enforcement on the sports nutrition industry with warning letters for 84 products.

What a week. The Tour de France riders pulled into Paris on Sunday and the opening ceremonies for the London Olympics take place this Friday evening. Consistent with these events are the accusations of doping and drug use to enhance sports performance.

For the Tour de France think Lance Armstrong, Flyod Landis, Alberto Contador and, this year, Frank Schleck. Hopefully, this year’s Tour winner, Bradley Wiggins will break the streak of winners who have been stripped of the yellow jersey. Or like Armstrong, have been plagued by accusations of drug use.

Not surprising, a handful of positive drug tests have already come in for would-be Olympic athletes, including for American sprinter, Debbie Dunn, and French steeplechaser, Nordine Gezzar. And the accusations against these athletes feel a little like the calm before the storm.

UK's role in 2012 Olympics

The official London Olympics testing program began last Monday (July 16) when the athletes’ village opened, and officials hope to conduct roughly 40 percent of drug tests before the games open this Friday. Overall, London organizers expect to take 5,000 samples from the 1,250 Olympic athletes over the course of the Games. This is up from 4,770 tests taken in Beijing four years ago and represents more testing than any other Olympic Games. The drug testing will be done in a lab donated by GlaxoSmithKline where samples will be examined for more than 240 banned substances.

When athletes do test positive, it’s not unusual for them to blame a dietary or sports performance supplement, amongst other excuses. The sports performance supplement category, whether for Olympic or everyday athletes, is one of three categories consistently under fire from the FDA for tainting the supplements industry (the other two categories include weight loss and sexual enhancement supplements). And so it seems the UK is taking the opportunity of having the Olympics in their backyard to crack down on sports supplements as well.

Controversial ingredients

Already this week the Medicines and Healthcare products Regulatory Agency (MHRA) announced that it had sent warning letters to retailers and manufacturers citing 84 products containing “dangerous ingredients.” The list of ingredients that the MHRA is warning against focuses on steroids, stimulants and hormones found mainly in muscle-building or fat-burning supplements, otherwise known as thermogenic products.

The ingredients regulator warned against ephedrine, synephrine, yohimibine. Products containing the controversial stimulant DMAA, found in such products as USP Labs Jack3d were also under investigation and it is expected that more warnings specific to DMAA will be following this crackdown. The MHRA has been working with UK Anti-doping, which recently suspended Welsh boxer Enzo Maccarinelli for six months for testing positive for DMAA after a boxing match in March.

Products named on the MHRA list included Jack 3d-maker, USP Labs for its “OxyElite Pro”. Nutrex “Lipo 6” range and Isatori “MX-LS7” were also on the list. USP Labs, Nutrex and Isatori, each received warning letters from the FDA earlier this year for the use of DMAA in products and failing to verify the safety of these products. Dymatize was also on the list for its “Dyma Burn Extreme.”

Is doping or taking products like DMAA what it takes to win?

I'm not sure. Sadly, the proliferation of doping and drug tests harkens back to the famous Goldman Dilemma study. In the 1980s, researcher Bob Goldman asked pro athletes if they would take a drug that would guarantee them an Olympic gold medal but would also kill them within five years. More than half of the athletes studied said yes. And as he repeated this study over the years, the results were always the same.

Although I am no longer able to suspend my cynicism around the doping that has plagued the Tour de France (I watch it now more for the scenery than the event), I will try to suspend my cynicism a little bit longer as I watch the Summer Olympics and hope that the half of the athletes who aren't willing to die or dope for a gold will prevail and remind us what true sport is all about.

UK cracks down on adulterated sports performance supplements | New Hope 360 Blog
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Old 07-28-2012, 05:36 AM
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GNC backpedals on DMAA and prepares for launch of 'banned-substance-free' MARKED range


Supplement giant GNC - which put its head above the parapet in April to defend DMAA while the rest of the trade kept silent - says it has since “made a very concerted effort to move away from DMAA products in our stores”.

http://www.nutraingredients-usa.com/Industry/GNC-backpedals-on-DMAA-and-prepares-for-launch-of-banned-substance-free-MARKED-range
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Old 08-03-2012, 07:25 AM
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France hunting ‘unauthorised’ DMAA products as Australia condemns stimulant


The French agency responsible for policing the country’s food supplements market told NutraIngredients today the controversial stimulant DMAA has been prioritised by its 2500 agents in a nationwide crackdown.

http://www.nutraingredients.com/Regulation/France-hunting-unauthorised-DMAA-products-as-Australia-condemns-stimulant
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Old 08-05-2012, 12:59 PM
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‘‘Designer Anabolic
5 Steroid Control Act of 2012’’

Link to bill:
http://www.supplementcounsel.com/blo...Draft-Bill.pdf


Q and A with Rick Collins, Steroid Bill and You: The New Designer Steroid Bill and YOU
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Old 08-07-2012, 05:32 AM
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Bodybuilding.com steroid spiking case shows retailers also responsible for dietary supplements: US Attorney

The $8.1 million in total fines for Bodybuilding.com and the DeLuca brothers should serve as a reminder for retailers as well as manufacturers of their responsibility to ensure dietary supplements really are dietary supplements, says a US Attorney.

http://www.nutraingredients-usa.com/Industry/Bodybuilding.com-steroid-spiking-case-shows-retailers-also-responsible-for-dietary-supplements-US-Attorney
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Old 08-13-2012, 07:40 AM
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Side Effect Sports & companies using PEAK-ATP & related nucleotides

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Originally Posted by NO HYPE View Post
Just wanted to dedicate a thread to any companies incorporating this PEAK-ATP/oral nucleotide garbage into their formulas. Maybe your general consumer base is completely unaware however, this practice is akin to using sand as a filler, and it's time to be exposed. Side Effect Sports is by far the worst offender with the primary bulk of their products being worthless nucleotides that are rapidly & extensively annihilated via luminal & hepatic-dephosphorylation/degradation following oral administration. I confronted the owner of SES but to no avail. He simply refused to acknowledge the pharmacokinetic-conundrum that they've gotten themselves into. I have a feeling the SES reps have even been instructed to not venture outside of the company promo section in fear of exposure. If you plan on using any of these supplements in the future.... be sure to get the IV bag ready.

So in addition to Side Effect Sports entire lineup consisting of this flavored sand: Pre-Workout/Post Workout/Muscle Builder/Fat Burner/Energy/Endurance

MassPro Sythagen, Gaspari SuperPump Max, BSN Hyper FX/Epozine-O2, MRM Driven, Inner Armour Power Peak, are also guilty.



Did ewe say..... placebo?





Br J Nutr. 2011 Feb;105(3):357-66. Epub 2010 Dec 6.
Coolen EJ, Arts IC, Bekers O, Vervaet C, Bast A, Dagnelie PC.
Oral bioavailability of ATP after prolonged administration.

Purinergic receptors are important for the regulation of inflammation, muscle contraction, neurotransmission and nociception. Extracellular ATP and its metabolites are the main ligands for these receptors. Occasional reports on beneficial results of ATP administration in human and animal studies have suggested the bioavailability of oral ATP supplements. We investigated whether prolonged daily intake of oral ATP is indeed bioavailable. Thirty-two healthy subjects were randomised to receive 0, 250, 1250 or 5000 mg ATP per d for 28 d by means of enteric-coated pellets. In addition, on days 0 and 28, all thirty-two subjects received 5000 mg ATP to determine whether prolonged administration would induce adaptations in the bioavailability of ATP. ATP supplementation for 4 weeks did not lead to changes in blood or plasma ATP concentrations. Of all ATP metabolites, only plasma uric acid levels increased significantly after the administration of 5000 mg of ATP. Prolonged administration of ATP was safe as evidenced from liver and kidney parameters. We conclude that oral administration of ATP only resulted in increased uric acid concentrations. On the basis of these findings, we seriously question the claimed efficacy of oral ATP at dosages even lower than that used in the present study.



J Int Soc Sports Nutr. 2012 Apr 17;9(1):16. [Epub ahead of print]
Arts IC, Coolen EJ, Bours MJ, Huyghebaert N, Cohen Stuart MA, Bast A, Dagnelie PC.
Adenosine 5' -triphosphate (ATP) supplements are not orally bioavailable: a randomized, placebocontrolled cross-over trial in healthy humans.

BACKGROUND:

Nutritional supplements designed to increase adenosine 5' -triphosphate (ATP) concentrations are commonly used by athletes as ergogenic aids. ATP is the primary source of energy for the cells, and supplementation may enhance the ability to maintain high ATP turnover during high-intensity exercise. Oral ATP supplements have beneficial effects in some but not all studies examining physical performance. One of the remaining questions is whether orally administered ATP is bioavailable. We investigated whether acute supplementation with oral ATP administered as enteric-coated pellets led to increased concentrations of ATP or its metabolites in the circulation.

METHODS:

Eight healthy volunteers participated in a cross-over study. Participants were given in random order single doses of 5000 mg ATP or placebo. To prevent degradation of ATP in the acidic environment of the stomach, the supplement was administered via two types of pH-sensitive, enteric-coated pellets (targeted at release in the proximal or distal small intestine), or via a naso-duodenal tube. Blood ATP and metabolite concentrations were monitored by HPLC for 4.5 h (naso-duodenal tube) or 7 h (pellets) post-administration. Areas under the concentration vs. time curve were calculated and compared by paired-samples t-tests.

RESULTS:

ATP concentrations in blood did not increase after ATP supplementation via enteric-coated pellets or naso-duodenal tube. In contrast, concentrations of the final catabolic product of ATP, uric acid, were significantly increased compared to placebo by ~50% after administration via proximal-release pellets (P = 0.003) and naso-duodenal tube (P = 0.001), but not after administration via distal-release pellets.

CONCLUSIONS:

A single dose of orally administered ATP is not bioavailable, and this may explain why several studies did not find ergogenic effects of oral ATP supplementation. On the other hand, increases in uric acid after release of ATP in the proximal part of the small intestine suggest that ATP or one of its metabolites is absorbed and metabolized. Uric acid itself may have ergogenic effects, but this needs further study. Also, more studies are needed to determine whether chronic administration of ATP will enhance its oral bioavailability.


Side Effect Sports & companies using PEAK-ATP & related nucleotides - Bodybuilding.com Forums
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Old 08-14-2012, 12:21 PM
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Splenda under attack

13 August 2012
Ingredients Network

Johnson & Johnson and McNeil Nutritionals are the targets of a class action law suit in California that alleges that the marketing of Splenda Essentials is deceptive and misleading.

Splenda Essentials is a higher-priced line of the no-calorie artificial sweetener sucralose that is fortified either with B vitamins, antioxidants, or fibre. Those additions, according to the law suit, are designed to give the impression that Splenda Essentials will help lose weight, avoid disease, or confer other health benefits.

But that impression is false, according to the suit brought by CSPI – the Center for Science in the Public Interest - a lawsuit filed today in federal court, which alleges that Splenda Essentials provides no health benefits whatsoever and short-changes consumers.

Since 1971, CSPI has been a strong advocate for nutrition and health, food safety, alcohol policy, and sound science. Its newsletter, Nutrition Action Healthletter, has around 900,000 subscribers in the United States and Canada.

Consumers, according to papers filed on behalf of CSPI, are increasingly health-conscious. In an effort to maintain or lose weight, many consumers try to “speed up” their metabolism, or increase their fibre intake to feel fuller longer. Some consumers aim to prevent illness and disease by increasing their antioxidant intake.

These health concerns, the papers go on to say, motivate the purchase and consumption of Splenda Essentials, from which the defendants significantly profit, commanding a premium price for Splenda Essentials by distinguishing it from regular Splenda and other no-calorie sugar substitutes, and by marketing it as a sweetener that “gives you a small boost of healthy nutrients”.

On average, the price of Splenda Essentials is 25% higher than original Splenda.
The suit claims that Splenda Essentials is deceptively named because consumers are led to believe that it is in some ways a necessity; that it does not confer the benefits claimed by Johnson & Johnson and McNeil Nutritionals; and that the Federal Trade Commission requires a higher standard of proof in order to permit the claims being made.


Splenda under attack - News-content | Ingredients Network | Food Ingredients news powered by Fi & Hi Europe
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Old 09-02-2012, 05:42 AM
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Man Blames Supplement for Fractured Penis

Natural Product Insider
August 31, 2012

HOUSTON—A 29-year-old Texas man is suing a supplement company, claiming its sexual enhancement product caused his penis to fracture during intercourse . Adrian Carter alleged that Haute Health Ltd, NJ, marketed VirilisPro as being safe, but knew that it could pose serious health risks.

In the early morning of May 11, 2011, Carter and his "paramour" (as the court documents put it) stopped at a Chevron gas station in Houston. Court records report that while paying, a store clerk told Carter he should consider buying VirilisPro, marketed by Haute Health as being "formulated to increase sexual performance, well-being, endurance, stamina and penile hardness all while intensifying overall sexual pleasure and satisfaction."

It is also advertised "as made with only natural ingredients to prevent harmful side effects" On its website, VirilisPro said it contains a proprietary blend of epimedium, tribulus terrestris, panax ginseng, rhodiola rosea, lycium Chinese and yohimbe extract.

Carter purchased the product and continued to a hotel room with his lover. During sexual intercourse, Carter "experienced significant pain and observed a large quantity of blood squirting out of his penis onto the sheets, walls and mirror in the hotel room," according to court documents.

Carter went to a local emergency room and was diagnosed with gross hematuria (blood in the urine), penile fracture and urethral injury. After the emergency room physicians degloved (removed all the skin) from Carter's penis, the doctor observed that Carter's urethra had completely separated.

Carter was released from the hospital a few days later, but a catheter wasn't removed for nearly three weeks; doctors told him he may never have an erection or be able to father children, and that he may have a permanent inability to urinate naturally.

In the suit, filed in the district court of Harris County, TX, Carter alleged VirilisPro was "defective and unreasonably dangerous for consumers." Carter said he used the product as it was intended for use. Therefore, Carter said Haute Health and its owners are liable for damages.

Further, Carter alleged Haute and its owners were negligent because they did not warn consumers of the dangers of VirilisPro, failed to test or inspect the product, and failed to remove VirilisPro from the market. Carter said Haute Health's owners knew that VirilisPro was extremely dangerous, but advertised the product as safe.

Carter said the product does not increase sexual performance as advertised; on the contrary, he alleged VirilisPro can result in penile fractures and the loss of sexual functioning
Justin Prochnow, attorney at Greenberg Traurig, who specializes in food and supplement law, said that the biggest task the Carter faces is proving that the use of the supplement was the proximate cause of his injuries. "I would assume that the plaintiff has an expert lined up that will attempt to tie the use of the product to the scenario that was alleged in the complaint and the defendants will almost certainly argue that there is no evidence that use of the product is responsible for the injuries."

While this type of case is rare, Prochnow noted, "Products liability cases involving serious injuries or death have certainly seen a swell of activity, as have other forms of litigation against supplement, food and beverage companies," Prochnow said. "Earlier in August, a case was brought in Tennessee against the makers of 5-Hour Energy for wrongful death after a man collapsed while playing basketball. As plaintiff lawyers continue to troll for cases against food, beverage and supplement companies, we are likely to see an increase in all types of cases, including products liability cases."

FDA is often concerned with the potential health effects of sexual health supplements, especially those that are adulterated. It is not often that such supplements are accused of such acute risks.

Unfortunately, there is no way for a company to completely insulate itself from litigation. "Of course, companies can put themselves in good positions by vetting claims to verify that they are legally permissible claims and ensuring that claims and the safety of products are supported by scientific evidence," Prochnow said. "Just because a case is filed does not mean that a company is liable for the claims alleged in a complaint and companies that vigorously defend claims that have no merit can get those claims dismissed. Most of the time, however it causes a company to divert time, money and energy to defending against the claims and plaintiff lawyers count on companies not wanting to make such expenditures and just settling."

Man Blames Supplement for Fractured Penis
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Old 09-07-2012, 05:43 AM
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New Study Shows No DMAA In Geranium

Stephen Daniells
Nutra Ingredients UA
09-07-2012 06:56 AM

Guess what? DMAA is not found in extracts from four different species of geranium and three cultivars, and the ingredient in a leading dietary supplement is probably synthetic, says a new analysis from Italian researchers.

Researchers from the University of Milan concluded: “No detectable amounts of DMAA were found in the geranium species analyzed and its presence in sport supplements indicates that synthetic amine has probably been added.

“Since DMAA is a sympaticomimetic agent, its presence could determine severe adverse effects in people using these food supplements in sport or in recreational activities.”

Writing in Drug Testing and Analysis, the researchers report they found no DMAA in extracts from four species three well-known cultivars of geranium, including Pelargonium citriodorum Hort. ex Breiter, Pelargonium denticolatum Kuntze, Pelargonium graveolens L’Hér, Pelargonium tomentosum Jacq, Pelargonium ‘Creamy Nutmeg’, Pelargonium‘Sarah Jane’, Pelargonium ‘Sweet mimosa’.

DMAA was also not detected in commercial geranium oil containing an extract from Pelargonium graveolens leaves, they added.

On the other hand, analysis of the DMAA from the dietary supplement Jack 3D (USPlabs, LLC) revealed that the suggested dose of 5.55 g of powder up to three times per day would deliver a DMAA intake of 27.6 mg, they said.

Controversy

DMAA (1,3-Dimethylamylamine, also known as methyl hexaneamine (MHA), and several other names) has rarely been out of the headlines in recent months since FDA issued warning letters to 10 manufacturers and distributors of supplements containing DMAA.

There has been intense debate about whether DMAA, which was first manufactured synthetically by drug giant Eli Lily in the 1940s, is in fact a constituent of geranium.

Only two analyses have reported it to be a natural consistuent of geranium: The controversial ‘Ping Paper’ by Chinese researchers published in the Journal of Guizhou Institute of Technology (1996, Vol. 25, pp. 82-85), and the recently published paper by scientists at Intertek AAC Labs and funded by USPLabs (Analytical Chemistry Insights, doi: 10.4137/ACI.S9969).

On the flip side, there are more studies that have failed to find DMAA in geranium plant material, including an analysis published in the Journal of Analytical Toxicology in June described as ‘comprehensive’ and ‘robust’ by respected members of the industry.

Scientists from ElSohly Laboratories, Inc. (ELI), Phyto Chemical Services, Inc. (PSI), the National Center for Natural Products Research, The University of Mississippi, and the US Anti- Doping Agency (USADA) reported that gas chromatography–mass spectrometry (GC-MS) and liquid chromatography–tandem mass spectrometry (LC–MS-MS) analysis of geranium oils or young and mature, fresh and dried leaves and stems found no detectable levels of DMAA.

The scientists further confirmed the results using liquid chromatography–high-resolution mass spectrometry (high resolution LC–QTOF-MS).

This was followed by an analysis published in Drug Testing and Analysis by Dr Dan Armstrong et al at the University of Texas, Arlington, which had similar conclusions.

New analysis


The Milan study used a high performance liquid chromatography (HPLC) technique to analyze geranium extracts, geranium oil, and Jack3D.

“DMAA was not found in any of the leaves or stems or in the commercial geranium oil included in this study.

“Approximately 30 mg per daily dose was found in the food supplement. Therefore, the amount of DMAA found in the supplement is most unlikely to have been sourced in nature, and it must be concluded that synthetic DMAA, known to be capable of causing severe adverse physiological effects, has been added,” they concluded.

More to follow…

Source: Drug Testing and Analysis
Published online ahead of print, doi: 10.1002/dta.1391
“Could 1,3 dimethylamylamine (DMAA) in food supplements have a natural origin?”
Authors: C. Di Lorenzo, E. Moro, A. Dos Santos, F. Uberti, P. Restani

DMAA not in geranium, says yet another study
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Old 09-11-2012, 05:40 AM
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Will the market or FDA deliver the final blow for DMAA?

There is a moment at the end of the legendary computer game, Mortal Kombat, where you have just beaten seven shades of something out of your opponent and all that is left is one final blow. ‘Finish him!’ says the game, and you ready your thumbs for the coup de grâce

http://www.nutraingredients-usa.com/Industry/Will-the-market-or-FDA-deliver-the-final-blow-for-DMAA
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Old 09-21-2012, 07:01 AM
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US nutritional supplements sales hit $11.5 billion

21 September 2012
Sales of nutritional supplements in the US reached $11.5 billion in 2012, according to a new report.

Market research firm Packaged Facts said that that dollar sales increased by 31.7% in 2012 and the category had a compound annual growth rate (CAGR) of 7.1% between 2008 and 2012. The report forecasts sales to reach $15.5 billion by 2017, in-line with a CAGR of approximately 6%.

Growth was led by general supplements (such as mineral, herbal and other non-vitamin supplements) which grew by 51% between 2008 and 2012. Other strong performers included multivitamins (+25.8%), “one and two letter” vitamins (+16.8%) and liquid supplements (+6.4%).

The ageing population of Baby Boomers, rising health care costs and an increase in the number of parents who buy supplements for their children are singled out by the report as key growth drivers.

Mass-market retail sales (such as supermarkets, drug stores and mass merchandisers other than Wal-Mart) increased by 5.4% in the year ending 10 June and accounted for around a third of sales. Natural/specialty stores (26%), drug stores (21%) and traditional supermarkets (12%) followed.

The report stresses the need to address declining supplements use in the 18-29 demographic and lower-than-average consumption amongst the US’ Hispanic population.

Also singled out is the need to target over 65 and Baby Boomer sales with fit-for-purpose marketing. Manufacturers must also ensure that products have a strong scientific basis to health claims as regulation and scrutiny becomes ever tighter, the report says.

US nutritional supplements sales hit $11.5 billion - News-content | Ingredients Network | Food Ingredients news powered by Fi & Hi Europe
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Old 10-05-2012, 06:54 AM
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SUPPLEMENT USAGE, CONSUMER CONFIDENCE REMAIN STEADY
ACCORDING TO NEW ANNUAL SURVEY FROM CRN

Council for Responsible Nutrition
WASHINGTON, D.C.,
October 4, 2012

Sixty-eight percent of American adults take nutritional or dietary supplements, says the Council for Responsible Nutrition (CRN), based on data released today from its annual consumer survey. The numbers are consistent with the previous years’ stats of 69 percent (2011), 66 percent (2010) and 65 percent (2009).

According to the results from the 2012 CRN Consumer Survey on Dietary Supplements, regular supplement usage also remains steady—the online survey showed that more than three-quarters of supplement users (76 percent) classify themselves as “regular” users, as opposed to occasional users (18 percent) or seasonal users (6 percent). In 2011, 77 percent of supplement users indicated they took supplements regularly; in 2010, 74 percent, and in 2009, 73 percent indicated similarly.

“Year after year, our survey demonstrates that a sizeable portion of the American population values vitamins and other supplements as part of the things they do to maintain good health,” said Judy Blatman, senior vice president, communications, CRN. “From a publicity-generating standpoint, it would be interesting to see huge swings; but from a healthy industry perspective, it’s encouraging that two-thirds of adult consumers in this country continue to identify themselves as supplement customers, year after year.”

The survey also looked at which products consumers are taking. The multivitamin is still the most popular, with 52 percent of all adults reporting usage in the past twelve months. The number of individuals aged 35-54 that reported using a multivitamin increased by five percent (54 percent versus 49 percent in 2011). In addition to the multivitamin, omega-3/fish oil (21 percent), vitamin D (20 percent), vitamin C (19 percent) and calcium (17 percent) round out the top five.
“While the multivitamin remains incredibly popular with a majority of Americans, consumer usage is not limited to the multi, or even just to vitamins,” said Ms. Blatman. “Thirty-three percent report taking specialty supplements, 16 percent take sports nutrition supplements, and 18 percent take herbals/botanicals.”

Consumer confidence in dietary supplements has also remained consistent in 2012, with 85 percent of American adults indicating that they are confident in the safety, quality and effectiveness of dietary supplements. Confidence in supplements has remained fairly consistent over the last several years with 84 percent of American adults indicating a favorable level of confidence in dietary supplements in 2011, 82 percent in 2010 and 84 percent in 2009.

The 2012 CRN Consumer Survey on Dietary Supplements was conducted August 27-31, 2012 by Ipsos Public Affairs and funded by CRN. The survey was conducted on-line and included a national sample of 2,006 adults aged 18 and older from Ipsos’ U.S. online panel. The survey has been conducted annually since 2000. Weighting was employed to balance demographics and ensure that the sample's composition reflects that of the U.S. adult population according to Census data and to provide results intended to approximate the sample universe. A survey with an unweighted probability sample of this size would have an estimated margin of error of +/- 2.2 percentage points.

Council for Responsible Nutrition-The Science Behind the Supplements
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Old 10-19-2012, 05:40 AM
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HHS Inspector General Raises Issues with Industry

Nutritional Supplement and Sports Nutrition | Industry Counsel

October 12th, 2012 | Author: Katie Weitzman

Earlier this month, the Department of Health and Human Services Office of the Inspector General (“HHS Inspector General”) issued a report which found that many of the dietary supplements it reviewed failed to substantiate their structure/function claims. The office reached these conclusions after studying 127 dietary supplements marketed for weight loss or immune system support.

Background

The major findings include these: (1) none of the manufacturers who submitted human studies (557/1624 substantiation documents) met all four of FDA’s recommendations for competent and reliable evidence; (2) FDA could not determine to what extent manufacturers had complied with the structure/function claim notification procedures; (3) 7% of the supplements studied were missing the required structure/function disclaimer; and (4) 20% of the supplements had prohibited disease claims on the label.

In response to these findings, the HHS Inspector General recommended that FDA: (1) seek explicit statutory authority to review structure/function claims; (2) improve its structure/function notification process; and (3) expand market surveillance to ensure that dietary supplement companies are making the required disclaimer in their structure/function claims and simultaneously not making disease-related claims.
Click here for the full report

What the Report Means for Your Business

This report shows the heightened attention dietary supplements are receiving in the regulatory world, and specifically the potential for FDA to devote more resources to monitor the supplement industry. Before going to market with a dietary supplement, it is as important as ever to make sure that you have sufficient studies to substantiate your claims. In addition, it is just as important to comply with FDA’s pre-market structure/function claim reporting requirements. This study was based on a random sample of 100+ dietary supplements whose unsubstantiated claims only brought more negative attention to the dietary supplement community. There is force in numbers — if we as an industry work together to comply with the current regulations, we will change FDA’s and HHS Inspector General’s opinions about the future of the supplement industry.

HHS Inspector General Raises Issues with Industry
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Old 11-06-2012, 05:08 PM
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Do Dietary Supplements Improve Micronutrient Sufficiency in Children and Adolescents?

The Journal Of Pediatrics
Received 30 January 2012; received in revised form 23 April 2012; accepted 4 May 2012. published online 20 June 2012

Objective

To examine if children use supplements to fill gaps in nutritionally inadequate diets or whether supplements contribute to already adequate or excessive micronutrient intakes from foods.

Study design


Data were analyzed for children (2-18 years) from the National Health and Nutrition Examination Survey 2003-2006, a nationally representative, cross-sectional survey (n = 7250). Diet was assessed using two 24-hour recalls, and dietary supplement use was assessed with a 30-day questionnaire.

Results


Prevalence of supplements use was 21% (<2 years) and 42% (2-8 years). Supplement users had higher micronutrient intakes than nonusers. Calcium and vitamin D intakes were low for all children. Inadequate intakes of phosphorus, copper, selenium, folate, and vitamins B-6 and B-12 were minimal from foods alone among 2-8 year olds. However, among 9-18 year olds, a higher prevalence of inadequate intakes of magnesium, phosphorus, and vitamins A, C, and E were observed. Supplement use increased the likelihood of intakes above the upper tolerable intake level for iron, zinc, copper, selenium, folic acid, and vitamins A and C.

Conclusions


Even with the use of supplements, more than a one-third of children failed to meet calcium and vitamin D recommendations. Children 2-8 years old had nutritionally adequate diets regardless of supplement use. However, in children older than 8 years, dietary supplements added micronutrients to diets that would have otherwise been inadequate for magnesium, phosphorus, vitamins A, C, and E. Supplement use contributed to the potential for excess intakes of some nutrients. These findings may have implications for reformulating dietary supplements for children.

Elsevier
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Old 11-08-2012, 03:24 PM
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Election Impact

Natural Products Insider
11/08/2012



There will be no administration change, and the party splits in the Senate and House pretty much held course, there were a few important issues underlined by the election 2012 panel at SupplySide West in Las Vegas. Mike Greene, VP of gov't relations for the Council for Responsible Nutrition (CRN), highlighted a few key Congressional races CRN was watching, most of which went favorably for industry. John Shaw, executive director and CEO of the Natural Products Association (NPA), added the races watched by NPA all went the way the organization had hoped. While many senators and congress members considered allies of the supplement industry won their races, so did a few known detractors, Including Rep. Henry Waxman, (D-CA).

The panel said the House is a facing a tremendous amount of change. The longtime Washington insiders this includes many new members of Congress—upwards of 74 freshmen. There is not yet a consensus on how many of them will be open to learning about the supplement industry and/or become proponents of the industry, but there is a real opportunity to reach out to these new members and educate them on the value and regulation of the industry. To that end, the panel also noted the low percentage (about 12 percent) of congress who were around when DSHEA passed, so the educational outreach needs to go further than just to freshmen members.

Patricia Knight, former chief of staff for longtime supplement industry advocate Sen. Orrin Hatch (R-UT) and current senior political advisor for the United Natural Products Alliance (UNPA), reminded the audience about the looming fiscal cliff. In the early part of 2013, the government may face across-the-board budget cuts unless Congress works together on budget and deficit issues. Such cuts would affect FDA at the same reduction percentage as it would all other agencies and departments, which could result in a slowdown on FDA work, including supplement guidance and enforcement issues. The consensus among the three SupplySide panelists was the current Congress is likely to "kick the can" to the next Congress, which will start after the fiscal cliff deadline arrives, by way of stopgap legislation that funds the government for a few months.

Election Impact
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Old 11-11-2012, 05:30 AM
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CRN annual consumer survey: Almost 70% of consumers supplement, more than half with multi

October 11, 2012 | By Michael Johnsen
drugstorenews.com




WASHINGTON — As many as 68% of American adults take nutritional or dietary supplements, according to an annual consumer survey conducted on behalf of the Council for Responsible Nutrition. Regular supplement usage also remains steady. The online survey found that more than three-quarters of supplement users (76%) classify themselves as “regular” users, as opposed to occasional users (18%) or seasonal users (6%). “Year after year, our survey demonstrates that a sizeable portion of the American population values vitamins and other supplements as part of the things they do to maintain good health,” stated Judy Blatman, SVP communications, CRN. “From a publicity-generating standpoint, it would be interesting to see huge swings, but from a healthy industry perspective, it’s encouraging that two-thirds of adult consumers in this country continue to identify themselves as supplement customers, year after year.”

The survey also looked at which products consumers are taking. The multivitamin still is the most popular, with 52% of all adults reporting usage in the past twelve months. The number of individuals aged 35-54 that reported using a multivitamin increased by five percent (54% versus 49% in 2011). In addition to the multivitamin, omega-3/fish oil (21%), vitamin D (20%), vitamin C (19%) and calcium (17%) round out the top five supplement ingredients.

“While the multivitamin remains incredibly popular with a majority of Americans, consumer usage is not limited to the multi, or even just to vitamins,” Blatman said. “[One-third of consumers] report taking specialty supplements, 16% take sports nutrition supplements and 18% take herbals/botanicals.”

Consumer confidence in dietary supplements has also remained consistent in 2012, with 85% of American adults indicating that they are confident in the safety, quality and effectiveness of dietary supplements.

The 2012 CRN Consumer Survey on Dietary Supplements was conducted Aug. 27-31 by Ipsos Public Affairs and funded by CRN. The survey was conducted on-line and included a national sample of 2,006 adults aged 18 and older from Ipsos’ U.S. online panel.

CRN annual consumer survey: Almost 70% of consumers supplement, more than half with multi | Drug Store News
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Old 11-18-2012, 03:06 AM
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Dry labbing practices ‘mushrooming’ and ‘metamorphosing’: Chromadex CEO

The practice of dry labbing in the industry is continuing, and the practice is becoming more sophisticated, increasing the need for continued vigilance, says Frank Jaksch, CEO of Chromadex.

http://www.nutraingredients-usa.com/Industry/Dry-labbing-practices-mushrooming-and-metamorphosing-Chromadex-CEO
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