Past News Items - April 2009
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Major Food Safety Legislation Underway: What is the Potential Impact of HR 759, HR 875, HR 1332, and S 425?
Call for Papers: Advances in Mind-Body Medicine
InnoVision Health Media invites submissions for its peer-reviewed medical journal Advances in Mind-Body Medicine, whichexplores the relationship between mind, body, spirit, and health. We are looking for fresh thinking, vigorous debate, and careful analysis.
Papers most likely to be accepted for consideration present authoritative information and compelling points of view on the role of psychological, social, and spiritual factors in health promotion and the prevention, treatment, and healing of illness. We are especially interested in review articles, theoretical models, opinion and commentary, case reports, and research reports. For more submissions information and guidelines, visit advancesjournal.com.
InnoVision Health Media and Its 3 Medical Journals Acquired by American Securities and ACI Capital
InnoVision Health Media, the parent company of 3 highly regarded, peer-reviewed medical journals—Integrative Medicine: A Clinician’s Journal, Alternative Therapies in Health and Medicine, and Advances in Mind-Body Medicine—has been acquired by a subsidiary of 2 New York–based firms: American Securities and ACI Capital. Both are leading middle-market, private-equity firms with consistent track records in building successful, enduring businesses.
InnoVision will operate as a wholly owned subsidiary and will maintain its Boulder, Colorado, offices. All current staff members will be retained, including the InnoVision management team.
In addition to the peer-reviewed medical journals, InnoVision publishes Natural Solutions: Vibrant Health, Balanced Living magazine and a series of condition-specific, consumer health books.
As part of the purchase, InnoVision will work closely with 1 of American Securities and ACI Capital’s other holdings, Potomac, Maryland–based Healthy Directions LLC. Healthy Directions has published a series of successful, subscriber-based health newsletters since 1971 and sells health-related products through the direct-to-consumer channel.
Among other services, Healthy Directions will provide marketing and subscription acquisition support for InnoVision. In return, InnoVision will help Healthy Directions market its products to consumers through print and online advertising and direct mail.
“We’re very pleased to have found a partner that believes in our business model and will help provide the resources needed to move it forward,” says Rob Lutz, InnoVision president. “We are passionately committed to delivering the highest-quality health and wellness publications and information to readers and practitioners. With the strength and stability of our new ownership group, we are looking forward to offering even better publications in the future.”
Major Food Safety Legislation Underway: What is the Potential Impact of HR 759, HR 875, HR 1332, and S 425?
All integrative medicine professionals know that good food is the basis of good health. What makes for good food legislation is yet another question. The public outcry over food contamination in recent years (including spinach, lettuce, tomatoes, and peanuts) has finally led some in Congress to enact legislative remedies. Several bills aimed at food safety have been proposed. Of the House bills, the US Food and Drug Administration (FDA) Globalization Act (HR 759) appears most likely to be voted on, with elements of 2 other bills, the Food Safety Modernization Act (HR 875) and the Safe Food Enforcement, Assessment, Standards, and Targeting Act (HR 1332), possibly incorporated into the final bill. In the Senate, the Food Safety and Tracking Improvement Act (S 425) is in committee.
All the bills would require new food safety rules for farms and/or food processing businesses. A vote on final bills in both Houses is likely shortly before Memorial Day.
The main House bill, HR 759, authored by John Dingell (D, Michigan), the House’s most senior member, is the one that will likely be given priority by the House. It proposes that all food-processing facilities register with FDA, pay annual fees, and keep extensive records. HR 759 also would give authority to FDA to establish “science-based” minimum standards for the safe production and harvesting of fruits and vegetables—including growing, harvesting, packing, sorting, and storage operations, along with standards addressing manure use, water quality, employee hygiene, sanitation, animal control, temperature controls, and nutrients.
An important aspect of the bill HR 875 is that it establishes a Food Safety Administration in the Department of Health and Human Services (HHS) and assigns all the authorities and responsibilities of the Secretary of HHS related to food safety to the Administrator of Food Safety. Additionally, it transfers to the Food Safety Administration all functions of specified federal agencies that relate to food safety laws and renames FDA the Federal Drug and Device Administration.
In a different vein, S 425 requires the Secretary of HHS to establish a traceability system for all stages of manufacturing, processing, packaging, and distribution of food through which the Secretary can retrieve the history, use, and location of each article of food shipped in interstate commerce. It also authorizes the Secretary to (1) refuse to provide, or to withdraw, inspections of an establishment for willful or repeated violations; (2) deny or suspend inspection in the public interest to protect the health or welfare of consumers; and (3) assess civil penalties for violations.
Though in some respects the bills seem well intentioned , many citizens and citizens’ groups are concerned. According to an action alert issued by the Cornucopia Institute (www.cornucopia.org), an educational organization supporting sustainable and organic agriculture, “Such one-size-fits-all food safety rules, especially preventative measures, created with industrial-scale farms and processors in mind would likely put smaller and organic producers at an economic and competitive disadvantage. A similar—voluntary—set of regulations in California have damaged the environment and hurt organic and fresh produce growers.”
Adds Food & Water Watch (www.fwwatch.org), a nonprofit consumer organization that works to ensure clean water and safe food, “There is plenty of evidence that one-size-fits-all regulation only tends to work for one size of agriculture–the largest industrialized operations. That’s why it is important to let members of Congress know how food safety proposals will impact the conservation, organic, and sustainable practices that make diversified, organic, and direct market producers different from agribusiness. And the work doesn’t stop there—if Congress passes any of these bills, the FDA will have to develop rules and regulations to implement the law, a process that we can’t afford to ignore.”
Alex Tiller, who runs a national farm management company in Denver, Colorado, and has started LeaveMyFoodAlone.org: A Petition to Defeat HR 875, agrees. Some parts of these bills “are currently written in a way that puts Uncle Sam in our organic gardens and on our small farms. It opens the door for future regulations and sets a standard of interference. Owners of organic gardens and small farms should be able to plant, pick, and sell without the threat of the FDA saying that we have to do it their way.” Grassroots action, says Tiller, is the only way: “A massive show of interest from consumers and producers should make our politicians think twice before adding additional, unnecessary, burdensome levels of bureaucracy into the lives of American agriculture producers.”
The sentiment from all: These bills should stay on people’s radar screens. As with most legislation, the real battle will be in the rule-making process that follows the passage of any bill.
If you are interested in becoming involved, contact the following representatives to urge them to support legislation that will protect organic and small-scale family farmers while strengthening food safety:
• Henry Waxman (D, California), Chairman of the Committee on Energy and Commerce—send a message through the Committee website at: http://energycommerce.house.gov/
• John Dingell (D, Michigan), the sponsor of HR759
• Rosa DeLauro (D, Connecticut), the sponsor of HR 875
• Jim Costa (D, California), the sponsor of HR 1332
• Sherrod Brown (D, Ohio), the sponsor of S 425
• Your own district’s representative, especially if he or she is a cosponsor of one of the food safety bills (see below for a link to cosponsors). To locate your representatives in Congress and send them a message through their website, click on this link: /www.congress.org/congressorg/officials/congress/
Or you can call the Capitol switchboard at 202.224.3121 and ask for your Representative’s and/or Senator’s office.
For more information and to see the cosponsors for the 3 House bills, go to http://www.cornucopia.org/2009/03/action-alert-critical-pending-food-safety-legislation/#more-1221. The information is listed on the bottom of the page. There are no cosponsors of the Senate bill.
At least one other separate piece of legislation, the TRACE Act (HR 814, sponsored by Diana DeGette [D, Colorado] and 5 cosponsors), would require a mandatory national animal identification system (NAIS), which has its own host of pros and cons, with seemingly more cons than pros.
Purported Lack of FDA Oversight In Supplement Industry Further Fueled by Nanoceutical Controversy
Nanotech-based dietary supplements, known as nanoceuticals, are increasing their market share in the supplement industry, but some consumer advocacy groups are calling for increased government oversight to ensure that these products are safe and effective—adding fuel to their complaint that FDA oversight of the entire industry is lax.
Nanoceuticals promise greater potency than other dietary supplements because nanoscale substances theoretically encapsulate nutrients to increase their solubility and bioavailability by leaving them to pass through the digestive system untouched until they reach what is called the “absorption site.” Dietary supplements are rare among nanotech-based products (which range from applications to electrical appliances and sporting goods to food to cosmetics—and almost anything in between) in that the potential for exposure to the nanoscale ingredients is extremely high since nanoceuticals are meant to be ingested directly as a mouth spray or swallowed as a pill, capsule, or drink. (For more information on the range of nanoceuticals, see http://www.nanotechproject.org/inventories/consumer/browse/categories.)
Although a nanoceutical providing more of a nutrient can be extremely beneficial, consumers need to be aware there could be some danger. Officials at Consumers Union, the publisher of Consumer Reports magazine, argue that maximum tolerable upper limits for many nutrients such as lycopene have not been established and it is unclear what, if any, harmful effects might occur at high doses attained with the nanoengineered form. (For a good summation, see http://www.consumersunion.org/pub/core_product_safety/004667.html.)
What worries consumer groups is that consumers have limited access to safety information about dietary supplements because of how the US Food and Drug Administration (FDA) views them. Pharmaceuticals can’t be introduced on the market until FDA reviews them for safety and effectiveness; dietary supplements, on the other hand, do not require FDA approval before they are marketed. Because dietary supplements are based on natural ingredients common to the human body, under the 1994 Dietary Supplement Health and Education Act (DSHEA), dietary supplements are regulated as food items and not as medical remedies unless the manufacturer claims that the supplement is a remedy for a particular ailment. Thus, dietary supplement manufacturers are responsible for ensuring the safety of their products before they are marketed, and FDA steps in only if the product is found to be unsafe after it hits the market.
The controversy over nanoceuticals adds to the already pervasive impression that FDA oversight of the entire industry is lax. According to the US Government Accountability Office (GAO), FDA at present has too little control over dietary supplements. The GAO, which released a report in mid-March after conducting an evaluation of FDA at the request of Congress, found that the agency lacks the information, resources, or recall ability it needs to adequately regulate dietary supplements, which are taken by reportedly 79% of American adults.
On the other side, many industry members are concerned that nanoceuticals may be used to open a proverbial Pandora’s box. “I predict this issue will likely be the flash point to reignite the Congressional discussion whether DSHEA should be revisited and amended,” says Loren Israelson, industry expert and executive director of the Utah Natural Products Alliance.
Recovery and Reinvestment Act Stimulates NCCAM Funding, Health Information Technology
The American Recovery and Reinvestment Act of 2009 (ARRA), signed into law by President Barack Obama on February 17, 2009, attempts in part to address long-neglected challenges facing the healthcare industry. Backed by ARRA, the National Institutes of Health (NIH) will be offering funding for biomedical and behavioral research through more than 3000 institutions across the country, including the National Center for Complementary and Alternative Medicine (NCCAM). NCCAM will be participating in NIH-wide funding opportunity announcements, including a new initiative titled NIH Challenge Grants in Health and Science Research (a href="http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html" target="_blank">http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html).
This new program will support research on topic areas that address specific scientific and health research challenges that would benefit from significant 2-year jumpstart funds. All NIH funding opportunity announcements and notices related to the Recovery Act will be announced on this NCCAM Web page, through the NCCAM RSS Feed (http://nccam.nih.gov/news/subscribe.htm) and in the NIH Guide (http://grants.nih.gov/grants/guide/).
In other ARRA news, the president named a Boston doctor and Harvard professor to lead his $20 billion-dollar effort to modernize the US healthcare system. Dr David Blumenthal will become the National Coordinator for Health Information Technology, charged with implementing health information technology provisions. ARRA offers financial incentives for doctors and hospitals to add or upgrade their technology systems to make the system interoperable while maintaining patient privacy. Blumenthal was most recently director at an institute for health policy at Massachusetts General Hospital and also led an information technology program at Harvard. Blumenthal worked on Capitol Hill in the late 1970s for Senator Edward Kennedy (D, Massachusetts) and advised President Obama during his 2008 campaign for president.
Frankincense Oil Targets, Kills Bladder Cancer Cells
An enriched extract of the Somalian frankincense herb Boswellia carteri has been shown to target and kill off bladder cancer cells, a new study published in BMC Complementary and Alternative Medicine reports.
Originally found in Africa, India, and the Middle East, frankincense oil has been used traditionally to treat colitis and arthritis. Given the oil’s success in alleviating these conditions, a team of researchers at the University of Oklahoma Health Sciences Center and Oklahoma City VA Medical Center tested frankincense oil’s efficacy against bladder cancer cells using human bladder cancer cells and normal bladder cells in culture. The study found that frankincense oil has remarkable antitumor capacities, as it is capable of distinguishing between normal and cancerous bladder cells in culture and kills only the cancer cells.
The researchers performed gene analyses to evaluate how frankincense oil affects bladder cancer cell survival and found that the oil suppresses cancer cell growth. The oil stops cell cycle progression and activates multiple cell death pathways that ultimately induce bladder cancer cell death. The study’s authors believe that their findings indicate that frankincense oil may now offer an inexpensive alternative therapy for patients currently suffering from bladder cancer. Bladder cancer is twice as common in males as it is in females, and in the United States, it is the fourth most common type of cancer in men.
Broccoli Sprouts Alleviate Allergies, Asthma
As the spring allergy season looms, people suffering from nasal allergies or asthma may have a new weapon in their antiallergy arsenal: broccoli sprouts.
In a study carried out at the University of California Los Angeles David Geffen School of Medicine and published in the March issue of the journal Clinical Immunology, researchers found that an oral preparation made from broccoli sprouts triggered an increase in inflammation-fighting enzymes in the upper airways. The compound sulforaphane seems to be mechanism responsible for the reaction. Sulforaphane is found naturally in broccoli and other cruciferous vegetables like Brussels sprouts, cauliflower, and cabbage, and it triggers an increase in antioxidant enzymes that counter cell damage and inflammation brought on by oxidative stress from sources like air pollution and environmental allergens.
The study included 65 healthy men and women who were given various doses of the broccoli sprout preparation or a placebo made from alfalfa sprouts over 3 days. The volunteers’ nasal fluids were collected and the activity of so-called Phase II enzymes, which control oxidative stress, was measured. Researchers found that the broccoli sprout preparation sparked an increase in the protective enzymes, whereas the alfalfa-based placebo did not.
Whether broccoli sprouts can actually alleviate allergy and asthma symptoms is not yet known, but the study does seem to indicate that compounds in broccoli sprouts are powerful in building up the airway’s self-defense system against oxidative stress. The study’s authors caution that it is still too early to start dosing allergy sufferers with cruciferous vegetables.