FDA herbal regulation update

I'd written a few weeks ago about the FDA's shift in perspective regarding herb and supplement regulation. It seems now that the comment period for their new position has been extended until the end of May.
FDA docket.
Comment page.


Farms, Food and Obesity

"You are what you eat" (or, for many herbalists, "You are what you assimilate"): important adages, helping to bring the idea of good, whole food up from the nether reaches of our consciousness. Michael Pollan, whom I believe to be a pretty observant plant person, has given this age-old wisdom a bit of a twist in a New York Times Magazine article entitled "You are what you grow". The general idea is that part of the problem with the modern "obesity epidemic" are the basic ingredients of the modern American diet: cheap, industrialized corn, wheat, and soy (sugar, starch and oil - with a little food coloring, salt, and some hydrogenation, you can make almost anything you want), and the government subsidies that keep it all flowing. There are some interesting socioeconomic observations in this article as well. All in all, a fascinating take on the roots of cultural wellness, and our often self-defacing relationship with food.


An update from Vermont

Well, it's the third time this spring that I've seen the snow melt from the gardens, and I'm hoping this time it's for good! A remarkable April has given the daffodils a bit of pause - but I know they're hardy and a little white stuff won't hurt them at all. Up here, the woods and fields know better than to burst into flower at the first signs of warmth -- so we are a bit luckier than folks in the rest of the country who have seen damaging frosts and snows that virtually eliminated crops of almonds, peaches, apples, pears and other fruits that rely on early spring blossoms.
In the warmth of my greenhouse, the last few days have been the perfect time to start a second round of herb seeds for the beds that were under cover-crop last season. Some highlights: Ashwagandha, Stevia, Arnica chamissonis, Spilanthes, Tulsi, various Datura species, Belladonna. These will hopefully find happy homes alongside the standbys like Echinacea and Calendula. Many others (mostly self-seeders like the poppies) are already beginning to grow stronger as the sun hits the garden beds. And last night, a beautiful and meditative end to the day, as the moon's new crescent reaffirmed the tide of growth that is sweeping over these ancient hills. Winter's great -- but so is Spring! Green growth, here we come!


Soy, broccoli and breast cancer

Researchers at UCLA just reported some interesting results at a recent meeting of the American Association for Cancer Research. It involves a flavone from soy, genistein, and a secondary metabolite of cruciferous vegetables (broccoli, kale, etc...). Both of these compounds were tested in vitro on human breast cancer cell lines, and the results seem to indicate that, in controlled lab conditions, these botanical constituents inhibit the cancer cells' ability to metastasize, or spread to other areas. This is important in cancer therapy, since it is the spread of the disease to vital organs such as the lungs, liver, or kidneys that ultimately proves fatal.
The flavones and diindolymethane confound the cancer cells' ability to recognize cellular surface receptors from other tissues, lessening their ability to latch on to new surfaces and thus preventing their spread. And while this report provides interesting and encouraging evidence, it should be taken with a grain of salt: so far, the data is very preliminary and come from cells cultured in a petri dish. Nevertheless, it shouldn't surprise herbalists that flavones have cancer-protective effects: this broad family of plants has been shown to protect us from cellular mutations, DNA damage, oxidative stress, and metastasis time and time again.


The FDA's regulatory plans...

Last December, the FDA issued a comprehensive position paper on "complementary and alternative medicine" (CAM), offering an opinion that deviates pretty radically from current practice. In the United States, there is still a large degree of freedom in choosing herbal medicines, dietary supplements, massage and other somatic therapies, and "functional foods" (like juices) as part of a comprehensive treatment plan. This most recent position paper proposes to bring all of the above under FDA regulation, which (in a worst-case scenario) might even lead to the criminalization of gardeners who grow medicinal herbs. While I can't see how this would be enforced, it does seem to add another voice to the growing governmental chorus that has been pushing against health freedom and the DSHEA (Dietary supplement, health and education act) under which we've been operating for over ten years now.
Here is a link to the FDA recommendations; additionally, please note that the comment period is still open. It is important to offer our opinions on this matter, as there is some historical precedent for the government listening to public comment (as occurred with the organic foods standards in the U.S.). I know, I'm an optimist, but it certainly can't hurt to make our voices heard. Here is the FDA comment page for this paper. Please tell your friends. Someone has to push back.


What were they thinking?

Here's further proof that if you spend enough time away from the forest and fields, whole foods, and our plant allies, your brain eventually turns to mush.
Researchers at Northwestern University published a new method for generating flavonoids in a laboratory. Previous efforts by organic chemists had resulted in failure, primarily because flavonoids are chiral molecules that have a single "handedness" in nature, and all the lab processes to date have generated an equal mix of both left and right handed molecules, which greatly limits their usefulness while also increasing their toxicity. Well, using a catalyst from Cinchona (Peruvian bark - quinine), these folks managed to synthesize flavonoids that are all identical to those found in nature. They started by replicating the constituents found in milk thistle and soy. The hope: new drugs to treat cancer.
Ok. The goal is admirable, and I respect the chemists' desire to find new therapies for cancer. But flavonoids are one of the most abundant and bioavailable of all plant constituents, being responsible for color (other than green) in plants. They are found in coffee, chocolate, peppers, corn, berries, flowers ... the list could go on forever. So why spend all this time on trying to find synthetic ones? Karl Scheidt, one of the researchers, says he wants "... to get selectivity and specificity using chemistry. A naturally occurring flavonoid may not have all the characteristics you want -- it may not be potent enough, for example -- but with chemistry you can go in and modify that structure, imbuing the molecule with more desirable traits, such as binding more effectively to a protein of interest or being less toxic to normal cells."
Ok. I can understand this goal as well. But here, in my opinion, is the bottom line (and the reason why you can really see that the chemists' brains are a bit disconnected): we have evolved on this planet side-by-side with plants. The way our DNA expresses, the way the cellular machinery works, the way cancer is (or isn't) controlled, are all intimately tied to the environment in which we evolved. Plant flavonoids have profound effects on all of those processes, and by definition they are eminently compatible with our physiologies (we are really part of the same being). The effects of a modified flavonoid not found in nature are wholly unknown in vivo. However, the benefits of a colorful, plant-rich, whole-foods diet are well researched and obvious to any herbalist. Why are we wasting time trying to develop weird unnatural therapies that are only used after the fact (i.e. after cancer has become detectable)? Why are we not devoting huge chunks of our governmental infrastructure to developing community gardens, promoting whole, fresh plant foods, and using natural flavonoids to prevent cancer in the first place?
I appreciate the intention behind this research. But I do feel that pursuing such strategies long-term will only lead to further disconnection from Nature, and thus further disease.

Can Coleus help in stubborn urinary infections?

Coleus forskholii, a tropical member of the Mint family, has been used in Ayurveda for thousands of years. Recent research points to its role in increasing levels of intracellular cAMP (cyclic adenosine mono-phosphate), a secondary messenger involved in a variety of biochemical processes. Increasing levels of cAMP has numerous, system-wide effects that mostly relate to "yin"-like changes: reduced inflammation, blood pressure, anxiety, irritability; and increased activation of GABA neurons (here is a useful summary of the research and biochemistry of Coleus).
Now, in a study that is receiving lots of media attention, scientists have found that Coleus extracts are useful in chronic urinary tract infections (UTIs) by reducing the adherence and number of bacterial colonies that hide in the folds of the bladder. Coupled with antibiotics, the study reports, these extracts lead to a more complete and long-lasting remission from UTIs.
Some problems with this research: first, it was done on an animal model (mice). And while cells lining the inside of the mouse bladders did "kick out" bacteria when exposed to Coleus, the plant extract was injected directly into the bladder and bladder tissue. This method is not too practical for us herbalists, and the study reveals nothing about the pharmacodynamics of orally-administered Coleus. So, interesting information. But despite the media attention, not incredibly useful... Hopefully this will spur additional research.


Hawthorn in congestive heart failure

The cardiologists met last month in New Orleans to review new strategies, therapies, and research related to cardiovascular health. Among the presentations, a new European study on hawthorn (Crategus species) leaves gave some interesting evidence that this herb, traditionally used for a range of cardiovascular ailments, has a positive effect on congestive heart failure, reducing mortality and improving quality of life. While the study is controversial (some argue that it shows no benefit for hawthorn over placebo), there are some undeniable positive results which, when coupled with the wealth of traditional use, keeps me coming back to my bottle of Vermont hawthorn tincture.
Traditionally, herbalists use the ripe red berries of this storied tree. Modern research has identified a spectrum of flavonoid-family chemicals in all parts of the plant (well, except the bark...), and research has therefore expanded into analyzing the therapeutic effects of leaf and flower, too - and the results, as this recent research shows, have been positive.
Some details:
  • A total of 2,681 patients with markedly impaired left ventricular function - indicating advanced congestive heart failure - were randomized to hawthorn extract or placebo for a duration of two years.
  • All patients were already receiving pharmacological therapy with ACE-inhibitors (83 %), beta-blockers (64 %), glycosides (57 %), spironolactone (39 %) and diuretics (85 %).
  • Researchers saw a 20 percent reduction in cardiac-related deaths among patients on hawthorn extract, extending patients' lives by four months during the first 18 months of the study. The safety of the compound was confirmed by a lower number of adverse events among the study group than those on placebo.
  • Patients taking hawthorn showed significant relative-risk reductions in the secondary end point of cardiac mortality after six months (by 41%, p=0.009) and 18 months (by 20%, p=0.046) but not at the 12-month or 24-month follow-ups (by 18% and 10%, respectively).
  • The protection was significantly stronger among the 70% of patients with ischemic disease. Researchers hypothesized the hawthorn extract is protective probably by being anti-ischemic.
The hawthorn extract "... is safe in patients with more severe congestive heart failure and left ventricular ejection fraction lower than 35 percent," said Dr. Holubarsch of Median Kliniken Hospitals in Bad Krozingen, Germany, and lead study author. "It postpones death of cardiac cause after 18 months and sudden cardiac death in an important subgroup of patients."

Another piece of evidence indicating the general life-promoting quality of colorful, flavonoid-rich plant foods! Additionally, continued reinforcement of hawthorn's beneficial effect on the cardiovascular system. My only complaint: as usual, this study uses a proprietary brand-name hawthorn preparation code-named WS 1442 (a standardized extract, 5:1, of hawthorn leaves and flowers produced by the Dr. Wilmar Schwabe Co. of Karlsruhe, Germany, standardized to contain 18.75% oligomeric procyanidins, a sub-class of the flavonoid family of phytochemicals). Sure, this makes the little pill easier to to take and consistent in dosage. But I bet study participants would have enjoyed a good hawthorn berry jam and/or delicious infusions of the spring leaves and flowers, maybe blended with a little linden flower (Tilia species) and lemon balm (Melissa officinalis).

Hawthorn Berry and Black Currant* Jam, from moonwiseherbs.com

-2 quarts Hawthorn berries
-1 quart Black Currants
-1-cup honey (or to taste)
-water to cover

(*Black Currants are high in pectin and make a great addition to thicken any jam or jelly.)

1. Place berries in a pot.
2. Cover with water (2 inches above the berries)
3. Add honey
4. Simmer until mixture thickens, (most of the liquid will be evaporated and the jam will thicken quickly when on a spoon that has been removed from the heat)
5. Run the mixture through a food mill, to remove seeds and stems.
6. Place back in the pot add a quart of water and simmer again until mixture is quite thick.

To can:

-Simmer canning jar lids
-Place mixture in clean canning jars
-Place lids on top
-Place jars in a canning kettle, cover with water (2 inches above the jar)
-Bring to a boil and boil for the appropriate time frame for the jar size: ½ pint 10 minutes, pints 15 minutes, quarts 20 minutes.