China Works to Regulate the Difference between Food and Traditional Chinese Medicine

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Traditional Chinese medicine (TCM) and Chinese food share a good deal in common. This includes not only ingredients, but also combinations of food used as therapies. For example, TCM espouses the consumption of certain specially prepared combinations of foods, considered to be cooling (yin)or heating (yang) foods, to balance forces within the body, maintain health, and treat illness.

TCM is backed by thousands of years of tradition and enjoys the trust of many in China. But it presents challenges for regulators that are seeking to strengthen a system that requires support for the safety and efficacy of drugs on the market and restricts the use of potentially harmful, untested additives in food. For example, Chinese authorities have recently banned poppy capsules because of their opium content, after a high profile story in which a chef was cooking with them in an effort to make his restaurants food addictive.

The latest draft of the Food Safety Law released for public comment in December of 2014 shows that China is increasingly concerned with the addition of drugs to food. Under that draft, those individuals who are directly responsible for a company impermissibly using pharmaceutical additives may be subject to 5-15 days of detention by the Ministry of Public Security.

It should be no surprise then that the National Health and Family Planning Commission (NHFPC), the primary agency for regulating food ingredients, recently issued proposed Administrative Measures on the Catalogue for Substances Traditionally Used in Both and Chinese Medicine (the Measures) to clarify the line between food and drugs. The Agency released the Measures in October 2014, with a deadline for comments ending shortly thereafter.

The Measures establish a catalogue of what substances may be used in both food and TCM. The Measures dictate the conditions for substances to be included in the Catalogue. For example, they must fulfill the requirements for food under the Food Safety Law, as well as be included in the national standards for TCM. They must also be recognized as edible in Chinas Drug Code, and normal use of the substance as a food must not have revealed short- or long-term harms to human health. The Measures also indicate what substances are not permitted to be included, e.g., those have a high rate of adverse events associated with them when used as a drug; those TCM substances that are, by law, protected wild animals or plants; and/or those for which the use might violate national law or not conform to food requirements.

The NHFPC will administer these criteria and amend the Catalogue, releasing proposed revisions for public comment. An amendment will take place when there is new information to consider, whether in the form of a new TCM standard, new adverse events reported, or other information that causes a reevaluation of a given substance or substances. As the NHFPC decides applications for new food ingredients (a separate process), it will consider adding those ingredients to the Catalogue.

While all of this sounds promising for resolving some of the stakeholder confusion that exists in this area, the proposed Catalogue itself (appended to the Measures) is fairly sparse on information. The user gets the Chinese and common English name of the substance, the name of the plant or animal from which it comes, its family or species, and some additional notes about it. But there is very little to indicate under what conditions it may be a food, a drug, or both. And there is little in the way of interpretations of the primary food and drug laws in China that would indicate if and when these categories can overlap. Whats more, while NHFPC primarily decides what can be added to food, the China Food and Drug Administration is in charge of drug ingredients. Yet, for some reason, the Measures do not appear to have been a joint effort between the two agencies.

It is important that Chinese regulators are thinking hard about these lines between overlapping product categories and their related safety issues. However, inclusion in this list, the way it is currently structured, will only answer so many questions, leaving many holes in the regulatory equation for these products.

Well-worded definitions of what constitutes a food and what constitutes a drug and guidance on hybrids would not only answer many of these questions, butthey would also make interpreting catalogues like the one that NHFPC is proposing much easier. Right now there does not seem to be guidance available to accomplish that task.

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China Works to Regulate the Difference between Food and Traditional Chinese Medicine

The Eczema Podcast #3: Acupuncture, Oils & Eczema Tips with Dr Peter Lio – Video

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The Eczema Podcast #3: Acupuncture, Oils Eczema Tips with Dr Peter Lio
In this episode, I #39;m incredibly excited because I interview Dr. Peter Lio, who #39;s a Doctor Clinical Assistant Professor at Northwestern University. He received his medical degree (and internship)...

By: Prime Physique Nutrition

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The Eczema Podcast #3: Acupuncture, Oils & Eczema Tips with Dr Peter Lio - Video

UMMS to develop a model for predicting gene expression in dendritic cells

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Insight into regulation of the genes that allow the immune system to recognize pathogens will help scientists rationally design new vaccines and prevent autoimmunity

WORCESTER, MA - UMass Medical School scientists Jeremy Luban, MD, and Manuel Garber, PhD, will be principal investigators on a 3-year, $6.1 million grant to develop a model for predicting whether a given gene will be turned on or off under specific conditions. Funding for the grant comes from the recently launched Genomics of Gene Regulation (GGR) program at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health. In total, $28 million in new grants aimed at deciphering the language of gene expression were awarded.

"Why a certain gene is expressed in a specific cell at a given time is an essential biological question that is fundamental to our understanding of life and disease," said Dr. Luban, MD, the David J. Freelander Professor in AIDS Research and professor of molecular medicine. "This grant will help us decipher the rules that govern gene expression. Ultimately, such information will help explain why one person survives a viral infection and another person does not."

Dr. Garber, PhD, director of the Bioinformatics Core and associate professor of molecular medicine said "Understanding of the regulatory code network - the DNA elements that control when and for how long a gene is expressed - has been elusive. The work we'll carry out in this project will allow us to model and test the regulatory code of dendritic cells. As a result, we would be able to predict the impact of mutations that do not directly affect the gene product but that affect how and when the gene is made."

Over the past decade, new scientific evidence suggests that genomic regions outside of the primary protein-coding regions of our DNA harbor variations that play an important role in disease. These regions contain elements that control gene expression and, when altered, can increase the risk for a disease.

The GGR grants will allow researchers to study complex gene networks and pathways in different cells types and systems. The resulting insight into the mechanisms controlling gene expression may ultimately lead to new avenues for developing treatments for diseases affected by faulty gene regulation, such as cancer, diabetes and Parkinson's disease.

"There is a growing realization that the ways genes are regulated to work together can be important for understanding disease," said Mike Pazin, PhD, a program director in the Functional Analysis Program in NHGRI's Division of Genome Sciences. "The Genomics of Gene Regulation program aims to develop new ways for understanding how the genes and switches in the genome fit together as networks. Such knowledge is important for defining the role of genomic differences in human health and disease."

Luban and Garber will be working with UMMS colleagues Job Dekker, PhD, co-director of the Program in Systems Biology and professor of biochemistry & molecular pharmacology; Oliver Rando, PhD, MD, professor of biochemistry & molecular pharmacology, and Scot Wolfe, associate professor of biochemistry & molecular pharmacology, to develop a model system for exploring gene regulation using human dendritic cells.

The dendritic cell is a key part of the innate immune system that distinguishes self from non-self and, when appropriate, directs the body to attack invading pathogens. In its immature state dendritic cells help prevent autoimmunity by keeping the immune system's T-cells from attacking the body's own cells. When an immature dendritic cell encounters a pathogen, though, a developmental switch is activated and the cell undergoes profound changes in gene expression as it matures. In contrast to immature dendritic cells, these mature cells elicit a potent immune response from T-cells that targets the pathogen.

Luban, Garber and colleagues will examine the changes that the dendritic cell undergoes when it encounters a pathogen and moves from the immature to the mature state. Among the factors they will look at are the genes that are turned on and off during this process. They will examine changes in transcription factors, chromatin modifying enzymes and the cis-acting DNA elements. Linking these elements to specific changes in gene expression should provide a model for predicting the expression of specific genes in dendritic and other cells.

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UMMS to develop a model for predicting gene expression in dendritic cells

More cancer trials, treatments for Holy Cross patients

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Cancer patients treated at Holy Cross Hospital in Fort Lauderdale will have access to more clinical trials and medical treatments under a new agreement with Massachusetts General Hospital, the largest teaching hospital of Harvard Medical School.

Dr. Patrick A. Taylor, president and CEO of Holy Cross Hospital, announced a five-year affiliation with the Massachusetts teaching hospital that expands a collaboration that began in 2010.

Patients treated at the Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross will now have available an increased number of clinical trials and medical treatments. Genetic counseling services will be expanded and offered to all cancer patients. Holy Cross patients also will have access to specialists at Massachusetts General Hospital Cancer Center and will receive referrals for second opinions and improved coordination of care.

"Our relationship with the Massachusetts General Hospital Cancer Center has been very successful as we collaborate on new ways to provide leading-edge oncology care to our mutual patients," Taylor said in a written statement. "This agreement brings additional access to advanced care for cancer patients living in South Florida as well as a continuity of care for their patients as they travel to our community."

Physicians in both organizations will participate in weekly multidisciplinary patient case presentations and regular quality improvement reviews. Patients may choose to have their medical records shared between specialists at the two hospitals. Under the agreement, physicians practicing in the Holy Cross Hospital Michael and Dianne Bienes Comprehensive Cancer Center will become non-clinical consultant members of the Massachusetts General Hospital medical staff.

"We are thrilled with the enhanced relationship we have now with Holy Cross Hospital in Fort Lauderdale," said Dr. David P. Ryan, clinical director of Massachusetts General Hospital Cancer Center and chief of Hematology Oncology at Mass General. "This is our first integrated collaboration outside the New England area, and we could not have chosen a better partner for this new way of providing the world's best oncology care to our mutual patients."

dgehrke@sunsentinel.com or Twitter @donnagehrke

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More cancer trials, treatments for Holy Cross patients