On September 29, the Senate Judiciary’s Subcommittee on Crime and Drugs held a hearing presided over by subcommittee chairman Senator Arlen Specter (D-PA) and ranking member Senator Orrin Hatch (R-UT) concerning hidden steroids in bodybuilding supplements. Sen. Specter, putting forth the idea that supplements should be pre-approved at the federal level before entering the market, has sparked an industry-wide stir.

Generated in part by a recent claim by Philadelphia Phillies pitcher J.C. Romero that he failed a drug test because a supplement he had been taking contained unlisted steroids, the hearing included testimony from the US Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), US Anti-Doping Agency (USADA), the Natural Products Association (NPA) and more. Some placed blame on the Dietary Supplement Health and Education Act of 1994 (DSHEA), calling for more government intervention in the dietary supplement industry. Others called on Congress to fund FDA with the resources it needs to do its job in a quick and effective fashion.

“Because FDA generally does not receive information on these products prior to marketing, FDA generally cannot identify violative products before they enter the marketplace,” testified Michael Levy, director of FDA’s new drugs and labeling compliance division. “After the products enter the market, we must undertake a painstaking investigation and analytical process to show that they are violative. FDA’s ability to solve the problem is limited.”

And while Sen. Specter raised the possibility of introducing a legal requirement for supplement makers to receive government approval before products hit the market, American Herbal Products Association (AHPA) President Michael McGuffin strongly disagreed. “Companies that are willing to ignore current laws would also ignore any new law,” he said, in support of DSHEA. “Enforcement is a better answer.”

Indeed, United Natural Products Alliance (UNPA) Executive Director Loren Israelsen cited the FDA as “chronically underfunded and understaffed,” arguing that the focus should be on improving the regulation already in place.

“Enforcement tools available to FDA include seizure of products, and fines and criminal sanctions against companies that ignore the law,” agreed Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “FDA just needs the resources and the political will to use them.”

“The hearing ended up as well as can be expected for the industry,” said Marc Ullman, industry attorney. “Dan Fabricant of NPA and Richard Kingham, Esq. of Covington & Burling did a superb job of explaining that this situation had nothing to do with DSHEA, but that it actually was caused by a lack of will and/or resources at FDA to enforce the law as written. Neither Mr. Levy nor the representative from USADA were able to explain how requiring all supplements to undergo a premarket approval process would make people who already ignore such a requirement comply.”

Still, Ullman believes that DSHEA is in jeopardy. “Not only because I think that this issue will not go away, but because I am concerned that overall lack of enforcement by FDA has created an atmosphere where frauds/charlatans feel that there is next to no risk in entering the supplement field and selling their illegal products,” he said, noting that the reaction would be not to blame the FDA, but to push for DSHEA’s rollback. “It is imperative that stakeholders take this threat seriously and support their trade associations and get involved with their representatives in Washington.”

Supplements of B6, B12 or folate do not affect cardiovascular health, despite lowering homocysteine levels, said a prestigious Cochrane review.

A review of the literature, which was limited to eight randomized controlled trials equivalent to 24,210 participants, found no difference between the B vitamins and placebo for heart attack, stroke or reductions in the risk of total mortality in people already suffering from heart disease.

The potential role of B vitamins in heart health, by reducing levels of the amino acid homocysteine reported to increase the risk of cardiovascular disease, is controversial. The controversy is set to continue, with the new review including only five trials with homocysteine data, and all the participants at risk of, or already suffering from, cardiovascular disease.

Epidemiological studies have linked increased blood levels of the amino acid homocysteine to an increased risk of cardiovascular disease. It has been suggested that by lowering the levels of homocysteine in the blood with B vitamins, people could cut the risk of this disease.

The new review found “no evidence that homocysteine-lowering interventions, in the form of supplements of vitamins B6, B9 or B12 given alone or in combination, at any dosage compared with placebo or standard care, prevents myocardial infarction, stroke or reduces total mortality in participants at risk or with established cardiovascular disease.”

A study from the American Journal of Cardiology, however, recently reported that folate supplements could reduce all-cause mortality in people with coronary artery disease (CAD).

Researchers from the Rabin Medical Center in Petah Tikva and Tel Aviv University reported that supplements of folic acid (at least 400 micrograms per day) with or without additional B vitamins were administered for an average period of 115 months.

The Israeli researchers reported that folate was associated with 28 percent lower all-cause mortality in people with high homocysteine levels (greater than 15 micromoles per liter), but not in people with lower homocysteine levels.

“Long-term folate-based vitamin therapy was independently associated with lower all-cause mortality in patients with CAD and elevated homocysteine levels,” said the researchers, led by Aviv Mager. “This association was not observed in patients with lower homocysteine levels.”

The Non-GMO Project Standard, the goal of which is to assist farmers, processors and manufacturers in avoiding the contamination of GMOs by progressively reducing the risk of GMO contamination, is now open for public comment until November 10.

The Standard is a consensus-based document that reflects a dynamic range of perspectives, and this will be the fifth public comment period. Comment periods are held twice yearly (spring and fall).

As part of this comment period, the Project will, for the first time, host a webinar on the Standard. The webinar will focus on the contents, scope, requirements and variances of the Non-GMO Project Standard, with an emphasis on making the document accessible to those for whom it is a first review. The session will also be valuable to those who are already familiar with the Standard; the Project will be covering the changes implemented during last spring’s public comment period and discussing the opportunity to submit feedback during the current public comment period, which closes November 10.

The Standard is process-based with a focus on continuous improvements; therefore it relies on input from farmers, industry members, retailers and consumers alike. To access a PDF version of the Standard, click here.

To submit comments, please click here.

To learn more, visit www.nongmoproject.org.

On October 13, North Dakota farmer Wayne Hauge, Vermont farmer and Founder of Cedar Circle Organic Farm Will Allen and a number of American hemp growers and entrepreneurs for the first time turned to public civil disobedience with the planting of industrial hemp seed at Drug Enforcement Administration (DEA) headquarters to protest the ban on hemp farming in the United States.

Hoping to focus the attention of the Obama Administration on halting DEA interference, Hauge, Allen, Hemp Industries Association (HIA) President Steve Levine, Dr. Bronner’s Magic Soaps President David Bronner, Vote Hemp Communications Director Adam Eidinger and Founder of Livity Outernational Hemp Clothing Issac Nichelson were arrested while digging up the DEA’s lawn to plant industrial hemp seed imported from Canada.

Hauge, along with North Dakota State Representative David Monson, sued the DEA in the US District Court of North Dakota in 2007, and the case is currently before the Eighth Circuit Court of Appeals. “In recent years there has been strong growth in demand for hemp in the US, but the American farmer is being left out while Canadian, European and Chinese farmers fill the void created by outdated federal policy,” said fourth-generation farmer Hauge. “When hemp is legalized, land grant universities across the nation will develop cultivars suitable to different growing regions to enhance yield and explore innovative uses such as cellulosic ethanol.”

“Dr. Bronner’s has grown into the leading natural soap brand in the US since incorporating hemp oil in 1999, due in significant part to the unsurpassed smoothness [hemp] gives our soaps,” said Bronner. “As an American business, we want to give our money to American farmers and save on import and freight costs. In this difficult economy, we can no longer indulge the DEA”s self-serving hemp hysteria.”

For more information, visit www.votehemp.com/DEAhempplanting.html.

The International Alliance of Dietary/Food Supplement Associations (IADSA) has spoken out against allegedly false statements vilifying the goals, purpose and transparency of Codex Alimentarius’ work on food supplements.

IADSA, which has been monitoring the work of Codex for the last 10 years, said that the statements circulating the internet in recent weeks have “absolutely no factual basis at all.”

These false statements range from claims that Codex plans to make supplements ‘prescription only’ products, to confusion about the legally binding nature of its guidelines and standards, and claims questioning the transparency of its meetings and procedures.

“There are currently false statements being circulated in a number of countries claiming that the activities of Codex Alimentarius will have a negative impact on food supplements. One of these statements, for example, is that it plans to make supplements available by prescription only. This is completely untrue,” explained Byron Johnson, chairman of IADSA. “Just four years ago, Codex adopted a guideline for vitamin and mineral supplements, which clearly placed supplements under food law. Codex bases its guidelines and standards on the latest available scientific knowledge gathered from experts across the world.

“All guidelines and standards adopted by Codex are voluntary; however, many governments can and do implement these standards since they bring their laws into line with international practice,” he added.

Codex Alimentarius is jointly run by the United Nations Food and Agricultural Organisation and the World Health Organization. Since its establishment in 1963, it has played a role in the development of food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Programme.

Kyowa Hakko USA (New York, NY), the wholly owned subsidiary of Tokyo-based Kyowa Hakko Bio Co., Ltd. and global manufacturer of health ingredients for use in dietary supplements, conventional and functional foods, cosmetic, industrial and pharmaceutical industries, has announced it is celebrating its 40th anniversary in the United States.

Internationally, Kyowa holds 92 US patents with a total of 433 worldwide. The company has invested in three research laboratories employing more than 150 staff members and four manufacturing facilities located in the US, Japan and China. With eight overseas offices strategically located throughout the world, Kyowa conducts business in over 80 countries.

Kyowa Hakko USA, with offices located in New York and California, offers manufacturers and formulators over 50 amino acids and related compounds, including D-Amino acids and branched-chain amino acids, as well as nucleic acids, bio-products and fine chemicals. The company is a US FDA inspected manufacturer, and the vast majority of the products are kosher with the “Circle K” approval.

For more information, visit www.kyowa-usa.com or call (212) 319-5353.