The U.S. Food and Drug Administration’s final analysis of certain flavors of “Total Body Formula” and “Total Body Mega Formula” has detected hazardous amounts of chromium.

On April 9, 2008, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html) Further FDA analysis of the products found high levels of chromium as well. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.

Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.

The new FDA finding comes as the U.S. Centers for Disease Control and Prevention (CDC) reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.

Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor after receiving reports of adverse reactions. (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html).

The FDA continues to investigate how excessive amounts of selenium and chromium got into the products.

The sole distributor of the “Total Body Formula” and “Total Body Mega Formula” products has voluntarily recalled the affected products.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online here.

More information about selenium and chromium and toxic effects of excessive intake is available from the CDC and the Agency for Toxic Substances and Disease Registry here.

http://www.fda.gov

More than 175 natural products industry stakeholders from 35 states and the District of Columbia gathered on Capitol Hill for the Natural Products Association’s 11th annual lobbying event, Natural Products Day. Natural Products Association members representing every component of the natural products industry educated members of Congress and their aides about the association’s legislative priorities, all of which promote consumer access and awareness of natural products.

“Nothing is more important that face-to-face meetings to establish relationships and a dialogue about the importance of natural products to the health of all Americans,” said Debra Short, president of the Natural Products Association. “I’m pleased to report that we once again had a series of productive meetings with legislators and staff and a capacity crowd on hand at our Congressional Champions Awards Reception.”

Short was referring to a packed evening reception where nearly 500 legislators and staff were able to sample a wide variety of natural products including health and beauty aids, dietary supplements, natural pet products and natural snacks and beverages, all donated by industry members (complete list of sponsors follows). The highlight of the reception was the presentation of the Natural Products Association’s Congressional Champion Awards. On hand to receive their awards were Sens. Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) and Reps. Chris Cannon (R-Utah) and Frank Pallone (D-N.J.). Sen. Tom Coburn (R-Okla.) and Rep. Edolphus Towns were also honored.

As in past years, the event consisted of an early morning briefing session and breakfast before participants adjourned to attend pre-arranged meetings with various congressional leaders. Attendees then spent the afternoon in meetings with lawmakers and key staff members from their districts and states.

During their meetings with House members, the constituents asked legislators to support Rep. Edolphus Town’s Dietary Supplement and Healthy Meal Replacement Tax Parity Act, H.R. 1107, which would ensure that natural products are given the same tax treatment as drugs and over-the-counter medications. Attendees also asked legislators to support H.R. 1363, introduced by Rep. Lynn Woolsey, which would raise the standards for school lunch programs. In addition, participants also asked lawmakers to oppose H.R. 1249, a bill to ban the safe, effective supplement DHEA.

In their meetings with senators, Natural Products Association members asked lawmakers to support S. 771, a companion bill to H.R. 1363 proposed by Sen. Tom Harkin, which would raise the standards for school lunch programs, and S. 770, a bill that would allow disadvantaged individuals to purchase dietary supplements with their food stamps. The members also emphasized the importance of defeating S. 762 and S. 2470, bills that would restrict or prohibit the use of DHEA.

Also this year, the association offered a “virtual march on Washington” for members and allied groups. Participants who could not come to Washington were encouraged to contact their members of Congress by phone, by mail, or by e-mail, and to create and post videos on YouTube. Allied organization Seniors Coalition collaborated with the association on H.R. 1249, encouraging their members to join association members in contacting their representatives and senators.

List of Sponsors

Aubrey Organics
Barlean’s
Burt’s Bees
Carlson
Country Life
Farmaesthetics
HerbaLife
Kyolic
Nature’s Way
NBTY/Solgar
NOW Foods
PetGuard
Smoothie King
Tree of LIfe
UNFI
Virgo Publishing
XanGo

For photos from Natural Products Day, please visit here.

Natural Products Association is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. Natural Products Association represents almost 10,000 retailers, manufacturers, wholesalers and distributors of natural products including foods, dietary supplements, and health and beauty aids.

Natural Products Association

As the demand for “natural” personal care products such as lotions, balms and shampoos continues to soar, manufacturers are responding with a host of new products. Some are natural, some aren’t. But how is a shopper to know? Until now, consumers had no idea what was truly natural since there was no standard definition of the term used by industry.

That is no longer the case. To end this confusion and help consumers, the Natural Products Association announced today a new certification program which defines natural and includes an easily-identified seal. Shoppers can expect the seal to begin appearing on certifier personal care products in the coming months.

“People want natural products because they are good for them and good for our environment,” said Debra Short, president of the Natural Products Association. “But anyone could claim their product was ‘natural,’ even if it had 100 percent synthetic or petroleum-based. That wasn’t fair to consumers or to companies who make truly natural products, and this seal will help end all that confusion.”

Widespread Confusion Over Natural

With public interest in natural personal care products growing stronger each day, research confirms consumers are very confused about what constitutes a “natural” product. A recent survey by Yankelovich showed that:

-More than three of every four (78 percent) American women think natural personal care is currently regulated or don’t know if it is, while nearly all (97 percent) think it should be

-Two of every three American women think a personal care product labeled “natural” should contain at least 95 percent natural ingredients

The New Natural Certification Program and Seal of Approval

Under the new program, products must follow strict guidelines set out by the Natural Products Association to merit bearing the seal. The criteria include, but are not limited to:

-Product must be made up of at least 95 percent truly natural ingredients or ingredients that are derived from natural sources
-No ingredients with any potential suspected human health risks
-No processes that significantly or adversely alter the purity/effect of the natural ingredients
-Ingredients that come from a purposeful, renewable/plentiful source found in nature (flora, fauna, mineral)
-Processes that are minimal and don’t use synthetic/harsh chemicals or otherwise dilute purity
-Non-natural ingredients only when viable natural alternative ingredient are unavailable and only when there are absolutely no suspected potential human health risks

The full set of criteria can be found on the Natural Products Association website at http://www.naturalproductsassoc.org/certifiednatural. A one-page fact sheet about the program follows this release.

The Natural Products Association standard is science-based and was developed by a team of experts from the association and natural products manufacturers. The advisory panel drew from a variety of sources, including relevant international standards, third-party organizations, existing research, and years of experience in the field. Advisors to the association are the leading natural personal care suppliers and manufacturers, including Aubrey Organics, Burt’s Bees, Badger Balm, California Baby, Farmaesthetics, Trilogy Fragrances, and Weleda.

Natural Products Association is the nation’s largest and oldest non-profit organization dedicated to the natural products industry. Natural Products Association represents almost 10,000 retailers, manufacturers, wholesalers and distributors of natural products including foods, dietary supplements, and health and beauty aids.

Natural Products Association

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Natural? Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.

“The FDA will not tolerate companies marketing unapproved drugs — products that have not proven to be safe or effective — as dietary supplements,” said Margaret O’K. Glavin, associate commissioner for regulatory affairs. “The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products.”

The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Although the products’ labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.

In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA’s investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA’s enforcement actions.

The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products. Consumers and health care professionals can report adverse events to FDA’s MedWatch program at 800-FDA-1088 or online at http://www.fda.gov/medwatch/report.htm. FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro, deputy chief, Civil Division, United States Attorney’s Office, District of Puerto Rico.

http://www.fda.gov

Patients with active tuberculosis are more likely to be vitamin D deficient than the rest of the population. New research, presented at the annual Society for Endocrinology BES meeting in Harrogate, shows that the majority of patients with tuberculosis (TB) have low levels of vitamin D, leading to the possibility that vitamin D supplementation could reinforce current treatments or be used as a preventative measure against tuberculosis.

Researchers at the Central Middlesex Hospital in London, led by Dr Vassiliki Bravis, examined the prevalence of vitamin D deficiency in an ethnically diverse population in London who had active tuberculosis. Out of 158 patients in the study, only 11 (7%) had adequate vitamin D levels. Additionally, patients’ vitamin D levels did not vary seasonally as expected, but remained constant throughout the year. It is currently unclear whether these findings represent a contributory factor to TB infection, with people with low vitamin D levels being more likely to contract the disease, or whether tuberculosis infection makes the body process vitamin D in an abnormal way, leading to patients becoming deficient. More research is now needed to establish whether vitamin D could provide a new line of treatment or preventative medicine against tuberculosis.

Vitamin D is manufactured by the skin after exposure to UV rays from sunlight. If you live in the UK, your vitamin D levels should fluctuate seasonally with the amount of sunlight you are exposed to, being higher in the summer and lower in the winter. Approximately 14.5% of the UK population is vitamin D deficient. However, vitamin D deficiency is more common amongst the Asian and African population, in whom TB infection is also more prevalent. Previous work indicates that vitamin D may help ward off tuberculosis as it mediates a key immune response against the bacterium that causes TB. Tuberculosis is a major global health problem, which causes over 2 million deaths every year.

Researcher Dr Vassiliki Bravis said:

“Previous research has shown that high levels of vitamin D can help inhibit tuberculosis infection. Our work shows that, within a London population, the majority of TB patients we treat are vitamin D deficient. Currently, we don’t know whether this vitamin D deficiency is a contributing factor towards them developing the disease or whether tuberculosis infection makes the body process vitamin D in an abnormal way, meaning that sufferers subsequently become vitamin D deficient. Looking towards the future, we now need to carry out trials to establish whether vitamin D supplementation could be used effectively to either prevent or help treat tuberculosis infection.”

Notes

This paper will be presented as a poster (number 17) at the Society for Endocrinology BES meeting. Posters will attended between 13:00 - 13:45 on Wednesday 9 April 2008. The abstract for this work is reproduced below: see here.

The Society for Endocrinology BES 2008 is Britain’s biggest scientific meeting on hormones, and is taking place at the Harrogate International Centre, Harrogate, from 7-10 April 2008. For the full programme, please see here.

Please mention the Society for Endocrinology BES meeting in any story

The Society for Endocrinology is Britain’s national organisation promoting endocrinology and hormone awareness. For general information, please visit our website: http://www.endocrinology.org

Abstract

Prevalence of Vitamin D deficiency in a London population diagnosed with active tuberculosis

Vassiliki Bravis, Huda Al-Hadithy, Vincent Mak

Central Middlesex Hospital, London, United Kingdom

Introduction: Epidemiological evidence suggests that Vitamin D (25(OH)D3) deficiency is an acquired risk factor for tuberculosis(TB). Lack of sunshine during the winter reduces 25(OH)D3 levels markedly, but darker skin pigmentation reduces 25(OH)D3 synthesis in African and Asian populations wherever they live.

Aims: To examine 25(OH)D3 deficiency and its associations in TB patients in a regional population.

Methods: Serum 25(OH)D3 concentrations were measured pre-treatment in patients with active TB, from January 2007 to September 2007. Prevalence of 25(OH)D3 deficiency and its relation to ethnic origin, skin colour, site of TB, duration in the UK, month of 25(OH)D3 estimation were determined.

Results: 158 patients (13 UK-born) were identified (71 female, 87 male). Mean age was 32(SD+14). Only 11(7%) had adequate 25(OH)D3 levels.

Of 61 Black patients, 2 had adequate 25(OH)D3 levels, 34 were insufficient, 25 were deficient. Of 87 Asian patients (60 Indian, 4 Pakistani, 2 Sri Lankan, 2 Bangladeshi, 2 Afghani), 7 had adequate 25(OH)D3 levels, 47 were insufficient, 33 were deficient. Of 4 White patients, 1 had adequate 25(OD)D3 levels, 2 were insufficient, 1 was deficient. Of 6 other patients(1 Nepalese, 2 Pilipino, 2 Brazilian, 1 Chinese), none had adequate 25(OH)D3 levels.

There was no association between serum concentrations of 25(OH)D3 and skin pigmentation, site of TB or duration of residence in the UK. There was no apparent seasonal variation in either TB diagnosis or 25(OH)D3 level. The expected rise of 25(OH)D3 to peak concentrations in the summer months was absent in our TB population. Of 20 patients with TB drug resistance only 1 had adequate 25(0H)D3 levels.

Conclusion: Patients with active TB have low serum 25(OH)D3 concentrations and do not show the expected seasonal variation. Possible abnormal handling of the vitamin may contribute to that. Clinical trials may help determine whether 25(OH)D3 supplementation prevents reactivation of latent TB infection.

Society for Endocrinology

An international study led by Dr. Brian Feagan of Robarts Research Institute at The University of Western Ontario in London, Canada has found that omega-3 fatty acids are ineffective for managing Crohn’s disease. The research is published in the April 9 Journal of the American Medical Association.

“A significant amount of time and money is spent annually on alternative therapies such as Omega-3 fatty acids, without strong evidence that they are beneficial to patients with inflammatory bowel disease,” says gastroenterologist Dr. Feagan, who is Director of Robarts Clinical Trials and lead author on the study. “I encourage Crohn’s patients to focus on prescription medications that we know are effective for preventing relapse of disease, such as azathioprine, methotrexate, and TNF blockers.”

Found in fatty fish such as salmon, mackerel, herring and sardines, omega-3 fatty acids have an anti-inflammatory effect and are therefore used in the treatment of inflammatory disorders such as rheumatoid arthritis and IgA nephropathy (a kidney disease).

The widespread belief among patients and health care providers that omega-3 fatty acids are effective treatment for inflammatory bowel disease may have stemmed from a relatively small Italian research study, published in 1996 in the New England Journal of Medicine, which found a benefit for preventing relapse of Crohn’s disease.

“Small, single centre clinical trials often overestimate the true effects of treatment” says Dr. Feagan. “That’s why it is important to conduct large-scale, randomized, multi-centre studies in order to confirm preliminary results.”

Feagan’s study includes two large-scale trials involving 738 Crohn’s patients (ten times the number of patients involved in the original New England study) at clinical centres in Europe, Israel, Canada, and the United States from January 2003 to February 2007. Both trials demonstrated that the omega-3 fatty acid formulation offered no benefit in preventing relapse in Crohn’s disease. However, patients who took the omega-3 fatty acid preparation did have significantly lower concentrations of triglycerides, a high level of which is a risk factor for heart disease.

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Source:
Kathy Wallis
University of Western Ontario

The Institute for Progressive Medicine (IPM), a medical clinic that focuses on safe, natural and alternative therapies in combination with traditional medical treatments, announced today the clinic’s Preconception Care Program. Preconception health care is for both parents and improves the likelihood of a healthy conception, pregnancy and birth for those who are having trouble conceiving or for parent’s-to-be who are looking for ways to have healthier babies. The program also includes alternative methods for pain relief.

Lead by Dr. Julie Kahn, IPM’s Preconception Care includes acupuncture, detoxification, herbal medicine, cycle charting, dietary and lifestyle plans and a program of natural medicines to combat the adverse affects of 20th Century lifestyle and living conditions. Environmental pollution, poor nutrient levels in soils and foods, toxic farming methods, chemical radiation and heavy metal exposure, weight problems, overuse of sugar, caffeine, alcohol and the stress of modern living all contribute to poorer general health, and consequently, poorer reproductive health. IPM’s program improves sperm count and quality in addition to optimizing egg development and is effective against infertility by itself, or as a supplement to fertility treatments under a reproductive endocrinologist.

“The program is great to use in conjunction with a fertility MD,” said Dr. Julie M. Kahn, N.D., L.Ac, expert in Naturopathic medicine and a licensed acupuncturist. “If a patient is spending thousands of dollars on fertility enhancing treatments, IPM’s Preconception Care program adds extra insurance. It is also good for people who just want to have a healthy experience, or who are not ready to go the traditional medical route of drugs or surgical procedures to increase fertility.”

Research on this type of program has shown a decreased miscarriage rate, no low birth-weight babies, little to no ear infections, and children have less allergies. In addition, the program has proven to decrease labor pains, assist in lowering high blood pressure, decrease nausea, anemia, heartburn and headaches during pregnancy.

“Preconception Care has proven to be very effective in improving the chances of fertility in women,” added Kahn. “There has been an overwhelming success rate with unexplained infertility that comes from practicing Preconception Care.”

Preconception Care at IPM offers support for couples with fertility problems and also for couples who simply want their child to have the healthiest start to life. It is not only used to achieve a conception, but also to improve the chances for a very natural and healthy pregnancy, birth and baby.

About Preconception Care

The program is modeled after the work done by the Natural Fertility Management program. Natural Fertility Management (NFM) program was first pioneered in Australia in 1975 by Francesca Naish, a naturopath who has dedicated her career to developing a comprehensive and holistic approach to fertility. For more information about their programs, please at http://www.fertility.com.au.

About Institute for Progressive Medicine

The Institute for Progressive Medicine is a revolutionary medical clinic that leans towards a natural and alternative medical routine. Started by Allan E. Sosin, M.D., a renowned physician who is board certified in Internal Medicine and Nephrology, IPM supports the patient’s physical, mental and spiritual well-being using the most natural, safe and effective methods available. IPM’s mission is to respect patient’s rights and look for the most natural and preventive path towards overall health. Dr. Sosin earned the title, Physician of the Year Award in 2000 from the National Health Federation.

Institute for Progressive Medicine

Administrationof omega-3 fatty acid supplements did not appear to improve the rate ofrelapse in patients with Crohn’s disease, according to a study releasedon April 9, 2008 in JAMA.

Crohn’sDisease is a gastrointestinal disorder which is indicated bychronicinflammation of the wall of the digestive tract, usually in the ileumor large intestines. The disease involves constant cycles of flare-upsandremission throughout the life of the patient, and without propertreatment, must be addressed surgically. It is considered aninflammatory bowel disease (IBD), similar to ulcerative colitis.Therapy to induce remission in Crohn’s disease is an unmet medicalneed, usually attempted with the use of certain immunosuppressivedrugs, which are associated with infection and other risks. ManyCrohn’s patients turn to alternative medications in the face ofdisappointing overall results.

Omega-3fatty acids unsaturated fatty acids usually found in marine fish. Theyhave anti-inflammatory properties, and have been used to treat someinflammatory disorders such as rheumatoid arthritis. Earlier studieshave evalued omega-3 fatty acids for the maintenance of remission inCrohn’s disease, but have had inconsistent results.

To attemptto rectify this, Brian G. Feagan, M.D., of the Robarts ResearchInstitute, University of Western Ontario, London, Ontario, andcolleagues performed two large trials of high-dose omega-3 free fattyacids as therapy in Crohn’s patients who were in remission. Thestudies, called the Epanova Program in Crohn’s Study 1 and 2 [EPIC-1and EPIC-2], were conducted between January 2003 and February 2007 at98 different centers in Canada, Europe, Israel, and the United States.There were 363 and 375 patients involved respectively, all with Crohn’sdisease which was in remission at the time. Patients were randomlyassigned in approximately equal numbers to either a group administeredfour grams per day of omega-3 fatty acids or a placebo, to be taken forup to 58 weeks.

Therewas no significant difference found in the relapse rates between thetwo treatment groups in either of the trials. In EPIC-1, 54 patientstreated with the fatty acids and 62 patients with placebo experienced aclinical relapse. The set of patients experiencing a relapse within 360days in the omega-3 group was estimated to be 31.6%, compared with35.7% in the placebo group. EPIC-2 had 84 patients who were treatedwith omega-3 fatty acids and 94 who took the placebo experiencedrelapse. The set of patients experiencing a relapse within 360 days inthe omega-3 group was estimated to be 47.8%, in contrast with 48.8% inthe placebo group.

Any serious adverse events were uncommon, and those that did occur weremostly related to Crohn’s disease itself.

Theresearchers believe that this conclusion is significant because it hasserious implications on the self treatment of Crohn’s patients. “Ourresults are important because the use of alternative medicines ingeneral, and omega-3 free fatty acid formulations in particular, iswidespread among patients with inflammatory bowel disease. This may bedue, in part, to dissemination of the positive results obtained in [atrial by Belluzzi et al]. Given the negative results observed in theEPIC trials and in [a trial by Lorenz-Meyer et al], we do not endorsethis practice, since patients with Crohn disease who are at risk forrelapse would be better served by taking medications of knownefficacy,” they write.

Omega-3 Free Fatty Acids for the Maintenance of Remission inCrohn Disease: The EPIC Randomized Controlled Trials
BrianG. Feagan; William J. Sandborn; Ulrich Mittmann; Simon Bar-Meir; GeertD’Haens; Marc Bradette; Albert Cohen; Chrystian Dallaire; Terry P.Ponich; John W. D. McDonald; Xavier Hébuterne; Pierre Paré; PavelKlvana; Yaron Niv; Sandro Ardizzone; Olga Alexeeva; Alaa Rostom;Gediminas Kiudelis; Johannes Spleiss; Denise Gilgen; Margaret K.Vandervoort; Cindy J. Wong; Guang Yong Zou; Allan Donner; Paul Rutgeerts
JAMA. 2008;299(14):1690-1697.
Click Here For Journal

Written by Anna Sophia McKenney
Copyright: Medical News Today

Hay fever is often seen as a trivial ailment but this annoying and sometimes distressing complaint now affects about 15 to 20% of the population in the UK. With spring>homeopathic medicines are available over-the-counter to help with the symptoms of hay fever (see list below). For treatment tailored to the individual (known as ‘constitutional’ homeopathic treatment) a qualified homeopathic practitioner should be consulted.

At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.

The dietary supplements seized were marketed and distributed on-line and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.

“The FDA takes seriously its responsibility to protect Americans from unsafe dietary supplements,” said Margaret Glavin, FDA’s Associate Commissioner of the Office of Regulatory Affairs. “Wednesday’s action shows FDA’s commitment to protecting consumers from potentially harmful products.”

“Working with the FDA, we are taking prompt civil action to protect the public health by seizing these illegal products and forestalling their shipment into the stream of commerce in any manner that could create harm to the public,” said U.S. Attorney Stephen J. Murphy. “I commend the professionalism and swift action of the FDA investigators who discovered and investigated this serious problem, and I am glad our lawyers could provide the legal muscle needed to support the seizure.”

FDA has not received scientific information on the safety of the seized products and cannot determine, at this time, whether they represent a hazard to consumers. Therefore, consumers who still have the products should strongly consider discussing the use of these products with their health care professionals. FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use. Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at http://www.FDA.gov/medwatch/report.htm.

On March 2007, the FDA warned Legal Gear (the predecessor of LG Sciences) to cease distribution of a different product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids.

http://www.fda.gov