Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, September 27, 2011

Cooking with Fall Greens: The Health Benefits of Kale

Fall is here and with it rich greens like kale, spinach, arugula, and spicy mustard greens -- all of which can be grown in your fall garden! Greens add flavor and color to meals, as well as necessary nutrients to support optimal health.

Kale, for example, is a rich source of antioxidants, including carotenoids and flavonoids, which may help protect the body from the effects of oxidative stress*. Dr. Weil includes a useful definition of oxidative stress on his website here.

Kale also may support the body's natural detox process.* Its sulfur compounds are thought to support Phase II detoxification - the step in which toxins in the liver are turned into neutral substances, making them easier to eliminate from the body.

Plus, it's tasty eaten raw or added to cooked meals. We like to saute our kale with onions, garlic, olive oil, and a sprinkle of fresh nutmeg. >> Download this kale recipe and a recipe for baked kale on ACHS Facebook (facebook.com/ACHSedu) here

Have tips for growing leafy greens like kale in your fall garden? Post them here! We'd also invite you to share your favorite kale recipes - variety is the spice of life!



*This information has not been reviewed by the FDA. It is intended for educational purposes and is not intended to treat, diagnose, cure, or prevent disease. Before making any significant changes to your health and wellness routine, it is always best to consult with your primary care physician or naturopathic doctor.

Tuesday, August 23, 2011

AHPA Congress on NDIs - September 8, 2011

We received this event notification from the American Herbal Products Association, which we thought you may be interested in attending. Please refer to the links within the post for further questions and information about how to register.

AHPA Congress on NDIs: Crafting an Industry Response & Filing Successful Notifications
When:
Thursday, September 8, 2011
8:30am - 5:30pm

Where:
Mesirow Financial Services Auditorium
353 North Clark St.
Chicago, IL 60654

Register by August 25 and save $100 on registration!
Register

The AHPA Congress on NDIs will sift through the clutter, the hype and unanswered questions on NDIs to provide clarity and help industry companies answer the following questions:
  • How would the FDA draft guidance on NDIs--if it is not amended--affect your business and the kind of products that you sell?
  • What specific sections of FDA's draft need to change to protect consumer access to a broad range of supplements?
  • Should your company file comments to try to change the FDA draft guidance?
  • What should your comments--and those from AHPA--tell FDA?
  • Do you need to file NDIs for your particular class of ingredients and/or products?
  • Exactly how do you do that?
  • The AHPA Congress on NDIs is geared to all companies that rely on new products and product innovation and whose products fall under the regulatory framework created by the Dietary Supplement Health and Education Act (DSHEA).

Session 1: Crafting an Industry Response to the NDI Guidance
McGuffin--widely considered to be one of the industry's leading experts on NDIs--will moderate this town-hall-style discussion on the development of industry's comments regarding the draft NDI guidance. Participants will have the opportunity to voice their concerns and positions and have them discussed among a panel of attorneys recognized as NDI experts, including:

Anthony Young, Esq., AHPA General Counsel and Partner, Kleinfeld, Kaplan & Becker
Alan Feldstein, Esq., Counsel, Collins, McDonald & Gann
Jim Prochnow, Esq., Partner, GreenbergTraurig (invited)
Ashish Talati, Esq., Partner, Amin Talati
Session 2: Filing Successful NDI Notifications
The afternoon session features preeminent companies with real-world experience in creating high-caliber, successful NDI submissions. The presenters will deliver practical, hands-on information and advice on the necessary steps needed to develop and submit NDI notifications for numerous product categories.

Hear from:

CANTOX, an InterTek Company
NSF-DBA
Spherix Inc.
The Program - Thursday, September 8, 2011
8 - 9 a.m. - Registration, Continental Breakfast, Networking
9 a.m. - 12:30 p.m. - Session 1
12:30 - 1:30 p.m. - Lunch, provided by Grifcon Enterprises
1:30 - 5:30 p.m. - Session 2
5:30 p.m. - Adjournment

Event Registration
Attendance is limited to 100 participants. Early registration is suggested. Click HERE to register.

Conference Location & Lodging Information
The AHPA NDI Congress will be held at the Mesirow Financial corporate headquarters, 353 North Clark St., Chicago, IL 60654.

A limited number of rooms have been reserved at the Residence Inn Chicago Downtown/River North for the night of September 7 at a special rate of $159 on a first-come, first-served basis. For reservations at the discounted price, contact Liz Rejniak, Gray's Travel Management, via phone: 800.966.8728, or email. Mention the "AHPA-Mesirow Congress" to receive this discount. Please do not contact the hotel directly.

Thursday, October 7, 2010

FDA Recall, Aromatase Inhibitors: What Does It Mean?


BY Dr. Arianna Staruch, ACHS Academic Dean

In case you've seen the FDA post Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall are are wondering what it all means ...

Aromatase is a cytochrome P450 (CYP) 19 enzyme that is critical in the metabolism of estrogen. In the ovary it is responsible for de novo production of estrogen from cholesterol. In tissues outside the ovary, aromatase converts androgens secreted by the adrenal gland into estrogen.

Aromatase is present in breast tissue and breast fat. Since 60% of premenopausal and 75% of postmenopausal breast cancer patients have estrogen-dependent tumors, this enzyme has been the target of drugs known as aromatase inhibitors. Breast tumors contain an abnormally high level of aromatase that generates a large amount of estrogen. Drug companies began developing inhibitors by modifying androgens, and 4-hydroxyandrostenedione (generic name of formestane) was the first aromatase inhibitor approved for use in breast cancer.

So how does this relate to dietary supplements? Since aromatase is responsible for converting testosterone to estrogen, and increasing testosterone has long been the goal of body builders, adding aromatase inhibitors was thought to be a new way of increasing testosterone and increasing muscle mass. Basically, it is a continuation of the anabolic steroid story made famous by professional athletes.

There are a number of natural aromatse inhibitors found in plants, such as mangosteen and resveratrol (found in grapes). These tend to have very low activity and studies are being done to look at their long-term effects on breast cancer incidence.

So here is the confusion, one of the products recalled by the FDA is called “iForce – Reversitol”, made by I Force Nutrition, a company that caters to the body building community. Resveratrol itself is NOT being recalled, but this product is. The reason is that this product, and others on the recall list, contain the added substance ATD (1,4,6-Androstatriene-3,17-Dione), which is a synthetic aromatase inhibitor. It is basically an unregulated drug, with drug-like side effects. The I-Force product information claims: “An extremely effective AI (Aromatase-inhibitor), ATD eliminates the production of estrogen in the body” and “Similar to Nolvadex, Trans Resveratrol works at the receptor level to block estrogen receptors."

You may know Nolvadex by its generic name, Tamoxifen.

So from a regulatory standpoint, this company added a drug-like substance to their products, compared their product to a drug in their product materials, and failed to show that this substance is Generally Recognized as Safe (GRAS).

The bottom line is, through this recall the FDA is not attempting to restrict access to the dietary supplement resveratrol, but is warning consumers about potential adverse health effects from a product that is not following FDA guidelines.

For more information about estrogen metabolism, aromatase and aromatase inhibitors, see the following papers:

Biochemistry of Aromatase: Significance to Female Reproductive. Physiology1. Kenneth J. Ryan:
http://cancerres.aacrjournals.org/content/42/8_Supplement/3342s.long

Aromatase Inhibitors in the Treatment of Breast Cancer:
http://edrv.endojournals.org/cgi/content/full/26/3/331

History of Aromatase: Saga of an Important Biological Mediator and Therapeutic Target; R. J. Santen, H. Brodie, E. R. Simpson, P. K. Siiteri and A. Brodie: http://edrv.endojournals.org/cgi/content/full/30/4/343

Tuesday, September 28, 2010

Ben & Jerry's Has Opted to Remove "All Natural" Label

A short news article announced that Ben & Jerry's has opted to remove the "All Natural" label from their products.

Though the company, which has more than a 30 year history, does use hormone-free milk and cage free eggs, and has reportedly committed to using only fair trade products by 2013, a spokesman for the company "told Shots, the company pulled the labels to avoid engaging in a debate over what's natural and what's not."

The FDA does not expressly define what 'natural' does and does not mean. Rather, they say on their website Q & A that "it is difficult to define a food product that is 'natural' because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances."

The Center for the Science in the Public Interest, however, who contacted Ben & Jerry's and requested the label "All Natural" be removed, noted in their press release that there are "plenty of ingredients that really are 'natural' are still bad for your health, such as the artery-clogging cream that is the main ingredient in Ben & Jerry's ice cream."

So the question seems to be, how are we defining 'natural'? When it comes to our food, does the label 'natural' reflect origin or a relative lack of potential "bad for your health" properties?

> Read the full-length NPR article "Ben & Jerry's Takes 'All Natural' Claims Off Ice Cream Labels" here.

> Here is a link to the FDA Q & A website "What is the meaning of 'natural' on the label of food?".

Friday, September 24, 2010

Got Drugs? Don't Flush. Drop Them Off at a DEA Take-Back Site.

Got drugs? Perhaps you have some old prescriptions lurking in your medicine cabinet or stuffed into the kitchen junk drawer? Resist the temptation to flush your old medicines. Drop them off instead.

The Drug Enforcement Administration has organized a National Take Back Initiative for this Saturday, September 25. Find a local drop site in your area on the DEA website here.

The FDA says some medicines can be disposed of in the trash by mixing with a substance like coffee grinds and sealing in a container. But many medicines can be harmful, if not fatal, if consumed by someone to whom they have not been prescribed. And flushing medicines down the toilet can also be harmful for the environment and leech into our water supply.

The FDA does have a list of medicines they feel are safe to flush. You can download the list here. But recent studies also suggest that pharmaceuticals can find their way into our lakes, streams, and drinking water. The effect on people and wildlife has yet to be determined. Why take the risk?

Play it safe. Gather your old medicines tonight and drop them off at a DEA take-back location tomorrow morning. We thank you!

Wednesday, September 22, 2010

Using Aromatherapy in Fall: Bring the Spirit of the Season Indoors

Fall has arrived! And, right on its heels, cooler weather. The good news … there is a lot to love about the fall: pumpkin patches, rich colors, root vegetables, warm herbal teas, and essential oils.

Just as nutritionists recommend eating with the seasons, there are aromatherapeutic essential oils that complement the seasons too. Select spicy, earthy, rich aromas to bring the spirit of the season indoors and to create feelings of warmth. We suggest a blend of sweet orange, cinnamon, ylang ylang, and lemon (the Festive Spice blend from our Apothecary Shoppe).

Sweet orange Citrus sinensis essential oil helps to support emotional well-being and has a sweeter, fruity scent. It blends well with basil, cinnamon, clary sage, clove, lavender, neroli, lemon, and nutmeg. For more information about sweet orange visit here.

Cinnamon Cinnamomum zeylanicum essential oil supports healthy digestion and stress management and has a spicy, earthy aroma. It blends well with ginger, nutmeg, rosemary, frankincense, and the citrus oils. For more information about cinnamon, visit here.

Ylang ylang Cananga odorata essential oil is attributed with analgesic, antidepressant, and aphrodisiac properties. It has a sweet aroma with long-lasting woody undertones and blends well with lavender, bergamot, the citrus oils, and sandalwood. For more information about ylang ylang, visit here.

Lemon Citrus limonum essential oil supports a healthy respiratory system and has a refreshing aroma. It blends well with cedarwood, chamomile, clove, eucalyptus, fennel, juniper, lavender, neroli, oakmoss, petitgrain, pine, sandalwood, and ylang ylang. For more information about lemon, visit here.

Festive Spice Blend
6 drops Sweet Orange
1 drop Cinnamon
2 drops Ylang Ylang
1 drop Lemon

We hope your first day of fall is fantastic and look forward to hearing more about your fall aromatherapy blends. Post any blending tips, photos, recipes …. here!

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Thursday, September 2, 2010

What You Need to Know About Food and Water to Be Safe During Hurricanes, Power Outages, and Floods

We're sending our best wishes to everyone who has been affected by Hurricane Earl and those who are currently preparing for the hurricane to land. You're in our thoughts. If we can be of assistance, please let us know.

Here is a link to the FDA's page What Consumers Need to Know About Food and Water Safety During Hurricanes, Power Outages, and Floods. Included are general tips for emergencies, as well as how to prepare for power outages and what to do in the event of flooding. For example, it may be a good idea to store some non-perishable food in waterproof containers and did you know that a full freezer can keep its temperature cool for up to 48 hours? To prepare for a power outage, freeze fresh water, which will help to keep other frozen items cool and will ensure you have fresh water. For more information, visit the FDA website here: http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm076881.htm

ACHS students and graduates have also posted their storm and power outage tips to ACHS Facebook. Read and post more tips here: http://www.facebook.com/pages/Portland-OR/American-College-of-Healthcare-Sciences/99091122240

For more information about how to prepare for Hurricane Earl, here's a link to FEMA's suggestions posted via Health.com: http://news.health.com/2010/09/01/east-coast-should-prepare-for-hurricane-earl-fema/

Thursday, May 27, 2010

ACHS President Dorene Petersen Responds to Supplement "False Claims" in the Media

Supplements are back in the news in a big way! Perhaps you caught the Today Show report on "false claims" or saw the article "Herbal supplements often sold with false claims" on the MSNBC website.

ACHS President Dorene Petersen responds to the reports on dietary supplements. Originally from MSNBC on newsvine.com:

Let's not underestimate the importance of personal education! Everything we consume--whole foods, beverages, processed foods, and supplements alike--all affect the quality of our overall health and wellness. That is why it is very important to educate ourselves about how our foods influence our health and interact (both positively and negatively) with our lifestyle choices.

Ideally, we would all have a thorough education in nutrition, food, and meal planning, and eat mostly whole unprocessed foods, with plenty of organic fruits and vegetables (particularly choosing organic for those on the EWG's "Dirty Dozen" list), quality protein and whole grains. However, since many of the foods we are currently eating on a daily basis fall short of the daily recommended intakes, supplements are a viable addition to a healthy lifestyle: "supplement" being the key word. Supplements do not take the place of wholesome, nutritious foods and a healthy lifestyle; rather, they are intended as a support for optimal health and wellness.

It is unfortunate that some companies have chosen to prioritize marketing (i.e., curative claims) instead of educating their customers, but that is not true of all companies. Unfortunately, the current regulatory system is not designed to reward companies for putting supplements through the costly and lengthy process to approve claims. Ill-informed manufacturers and those looking to make a quick buck sometimes do make unapproved health claims: This is why the FDA already has powers under DSHEA to enforce the regulations.

The best way to address this is with education: For manufacturers, consumers, retailers, and healthcare providers. As consumers, though, it is also our responsibility to be educated consumers, to recognize a curative claim for what it is, marketing, and to understand that there is no panacea, no cure-all, for sickness and disease. As educated consumers, it is our responsibility to make good choices about what we put into your bodies for sustainable health and wellness. Dietary supplements, including herbs, have a role to play in achieving wellness and a healthy balance. Who wouldn't prefer to pick peppermint from their own herb garden and make a cup of tea to soothe an upset stomach?

It also seems important to mention that the FDA's Good Manufacturing Practices (GMPs) ensure that the purity and quality of nutritional supplements meet the standards similar to over-the-counter and prescription medications. But, this is an ongoing process that began with the largest companies and is "working its way down," so to speak. There is a detailed explanation of GMPs on the FDA website:http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm173997.htm

It's also important to note that dietary supplements are not the only category of products with issues related to health claims, purity, and quality. There are even graver concerns with prescription pharmaceutical quality and appropriate use. Prescribed drugs have been in the spotlight recently with several celebrities losing their lives due to a potent combination of pharmaceutical drugs. These are just the tip of the iceberg--regular people die every day from using prescription pharmaceuticals as prescribed without a blip in media coverage. Off label use is rampant--that is use of a prescription pharmaceutical for a purpose not approved by the FDA.

Another article of interest: "The How and Why of the Dietary Supplement Safety Act of 2010 Proposed by Senator McCain":http://achsnews.blogspot.com/2010/02/how-and-why-of-dietary-supplement.html

Sincerely,
Dorene Petersen, President
American College of Healthcare Sciences


Monday, May 24, 2010

Alfalfa Sprouts Recalled: Grow Your Own

The U.S. Food and Drug Administration website has listed a recall of alfalfa sprouts, which have been linked to a recent Salmonella outbreak.

Salmonella, the website explains, "is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Consumers with the above symptoms should consult their physician"

But there's no need to cut sprouts from your diet ... just grow your own! In about a week, you can grown your own fresh alfalfa sprouts to cut and use in salads, on sandwiches, and however else you like them! Sprouts are rich source of nutrients, and have also been show to include concentrated amounts of phytochemicals, which support optimal health and wellness.

To grown your own alfalfa, follow these simple steps from the Happily Domestic blog:

1. Place 2 tablespoons of seeds in a 1/2-gallon sprouting jar with three times as much water as seed and soak overnight.
2. Drain the water from the jar (either through the lid or a piece of cheesecloth) and rinse the seeds in fresh, lukewarm water. Then, drain again.
3. Lay your jar at an angle in a warm, dark place (about 70 degrees F). (70 degrees F.)
4. Then, rise and drain your seeds twice a day for 4 or 5 days. On the last day, place your alfalfa sprouts in indirect sunlight to help them develop chlorophyll. (The tiny leaves will turn green in a few hours.)
5. Remove the alfalfa sprouts from the jar and place them in a bowl; rinse well. When the sprout hulls float to the surface of the water, skim them off. Remove your sprouts from the water and shake out any excess water.
6. Alfalfa sprouts will keep for about a week. Be sure to store them in the fridge.

For more tips about how to eat sprouts and fun, family-friendly growing projects (like broccoli sprouts) download your free copy of the ACHS Wellness Guide here: http://www.achs.edu/news/news-detail.aspx?nid=225

Thursday, April 8, 2010

Vitamin B6 in the Regulatory Arena

By Dr. Arianna Staruch, ACHS Academic Dean

On April 6, 2010, there was an alert released by the Alliance for Natural Health that stated “A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why?”

The “why” seems to be about who gets to control the money gained from selling a product, which puts the supplement industry at odds with the drug industry. This fight over pyridoxamine is an example of this struggle that has the U.S. Food and Drug Administration (FDA) in the middle.

Let’s clarify this issue. According to the Linus Pauling Institute: “There are three traditionally considered forms of vitamin B6: pyridoxal (PL), pyridoxine (PN), pyridoxamine (PM). The phosphate ester derivative pyridoxal 5'-phosphate (PLP) is the principal coenzyme form and has the most importance in human metabolism.”[1]

Pyridoxine is the natural form of the B6 vitamin and PLP is the active form. The FDA has been reviewing the status of the pyridoxamine form of the vitamin since 2005. A petition, submitted on behalf of BioStratum, Inc., requesting the removal of dietary supplements containing the drug pyridoxamine was first submitted to the FDA on July 29, 2005.

BioStratum is the manufacturer of Pyridorin, a form of pyridoxamine dihydrochloride that was submitted as the subject of an Investigational New Drug (IND) Application filed with the FDA in 1999 as a potential therapeutic agent to slow or prevent the progression of diabetic neuropathy. It was granted fast-track status in 2002. A phase II trial was started that was expected to lead to the approval of this drug by 2005 or 2006. This current action by the FDA may reflect the completion of these studies and the impending approval of the drug.

BioStratum claims that after they released the data from their phase II trials, supplement manufactures began marketing pyridoxamine as a dietary supplement, and that pryridoxamine was never marketed as a dietary supplement before the compound was part of the Pyridorin IND filing. They further state that existing dietary ingredients must be chemically altered by sophisticated multi-step synthetic processes to produce pyridoxamine. This is why they petitioned the FDA to list pyridoxamine as a drug and not as a dietary supplement.

One of the supplement companies selling 100mg pyridoxamine directed consumers to a website that made specific health claims that “pyridoxamine may be useful in treating diabetic retinopathy.” This is clearly in violation of FDA regulations that say that dietary supplements can only make structure function claims, not health claims.

Another problem is that pyridoxamine can have potential side effects, and as part of an investigational drug study, its use should be monitored by a physician. When BioStratum analyzed the 100mg product from the supplement company, it found that some of the capsules contained up to 140mg of pyridoxamine, and also contained up to 8.3% impurities. (Drugs and supplements manufactured according to Good Manufacturing Practices (GMPs) would never be allowed to have this level of contamination.) This could further exacerbate side effects.

In September 2005 the Council for Responsible Nutrition, a leading trade association representing dietary supplement manufacturers and ingredient suppliers, contested BioStratum’s petition stating that pyridoxamine is one of the two natural forms of B6 found in animal products used as human food. They also stated that pyridoxamine is on a list of dietary supplements marketed prior to 1995 and the passage of the DSHEA. This Natural Products Association (formerly the National Nutritional Foods Association or NNFA) list included Pyridoxine ketoglutarate. BioStratum countered in September of 2005, saying that pyridoxamine was not marketed as a dietary supplement until after July 1999, and the NNFA list was never verified by any agency. In addition, they say that pyridoxaime can be metabolized in vivo to the active form of PLP, but that it is not the natural form of the vitamin, which is pyridoxine. However, a dietary supplement fact sheet on B6 produced by the Office of Dietary Supplements of the National Institutes of Health (NIH) listed pyridoxamine as one of the three major chemical forms of B6 in 2002.

Further, Jarrow Formulas began marketing “Pyridoxall with pyridoxamine”. The label lists pyridoxamine 50mg 2500% DV, pyridoxine 5mg 250% DV, and pyridoxal-5-phosphate 250% DV. The abbreviation “DV” refers to the Daily Value found on the NIH vitamin Fact Sheet for B6 from 2002. The RDA for B6 is 1.3-1.7mg and the Upper Tolerable Limit (UL) is 100mg. Above 100mg can cause reversible nerve damage.

The public should be involved in the decisions being made by the FDA. If you want to continue to have access to specific products sold by supplement manufactures, then add your voice to the FDA debate. Understand the issue and the players involved and know that both sides do have a financial interest in the debate.

If you would like to review the FDA document for yourself, click here for the link.

References:
[1] http://lpi.oregonstate.edu/infocenter/vitamins/vitaminB6/

Wednesday, April 7, 2010

ANH Alert: Protect Your Right to Natural and Bio-available Vitamin B-6


Alert: Protect Your Right to Natural and Bio-available Vitamin B-6

The Alliance for Natural Health has posted an alert about a potential ban on vitamin B6. As reported on their website, the pharmaceutical company BioStratum wants sole use of pyridoxamine, a natural form of the vitamin, in a drug. "The company filed a so-called citizens petition," according to ANH-USA, "and the FDA agreed. [...] You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer the question."

Vitamin B6 is water-soluble and part of the vitamin B complex. Pyridoxal phosphate (PLP) is the active form and is essential for many in the human body. PLP plays a part in amino acid metabolism, gluconeogenesis, lipid metabolism, neurotransmitter synthesis, histamine synthesis, hemoglobin synthesis and function, and gene expression. Vitamin B6 is also important "for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions."[1]

A B6 deficiency can manifest in symptoms like seborrhoeic dermatitis-like eruption, atrophic glossitis with ulceration, angular cheilitis, conjunctivitis, intertrigo, and neurologic symptoms of somnolence, confusion, and neuropathy. [2]

"Unfortunately," ANH-USA says, "this isn’t all the bad news about vitamin B6. All forms of B-6, natural or synthetic, must be converted to P5P, another natural form, for the body to use it. Another drug company, Medicure Pharma, wants sole use of P5P and so has petitioned the FDA to ban its use as a supplement as well.

"Medicure has yet to market a drug made from P5P, but wants the ban to take place now. And never mind that any individual unable to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive."

If you have yet to send a message to the FDA, you can send one here.

Read more about the potential FDA ban on the Alliance for Natural Health website here.

[1] http://www.anh-usa.org/alert-protect-your-right-to-natural-and-bio-available-vitamin-b-6/
[2] Andrews' Diseases of the Skin, 10th Edition, Elsevier.

Thursday, March 4, 2010

FDA Commissioner Hamburg Posts Open Letter to Food Industry

NPR yesterday posted a short article on their website linking to an open letter from FDA Commissioner Margaret Hamburg to the food industry "exhorting them to do a better job and highlighting some areas of special concern."

Her "beef," NPR comments, is that "companies should stop misleading consumers by trumpeting a food as free of trans fat--implying that it's a healthy choice--when it also happens to be be high in unhealthy saturated fats." Nor should they make health claims about foods for kids younger than 2 or "representing that foods can cure or treat a disease."

NPR cites this example: "Nestle Drumstick Classic Vanilla Fudge [...] proclaims '0 g Trans Fat,' while the fine print shows 10 grams of saturated fat per serving, or 50 percent of the recommended daily amount."

>> You can read the Open Letter to Industry from Dr. Hamburg here.

>> To read the original NPR article, click here.

Tuesday, February 16, 2010

The How and Why of the Dietary Supplement Safety Act of 2010 Proposed by Senator McCain

BY Dr. Arianna Staruch, ACHS Academic Dean

In Jan 2009, the Government Accountability Office (GAO) released a report suggesting that the FDA should take further actions to improve oversight and consumer understanding of dietary supplements. This report was triggered by the three-fold increase in adverse event reports received by the FDA since mandatory reporting went into effect on December 22, 2007.

The GAO wanted to know if the FDA was able to “identify and act on concerns about the safety of dietary supplements, and foods with added dietary ingredients, and to ensure that consumers have useful information about the safety and efficacy of supplements.”[1] What it found was that the FDA “has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry.” In addition the FDA “is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients.”[2]

There is also concern that some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives.

In response to this GAO report, Senator McCain proposed the Dietary Supplement Safety Act of 2010.[3]

To address the lack of information about dietary supplement firms, the bill proposes the registration of “dietary supplement facilities” which would be required to file annually a list of all dietary supplements “manufactured, packaged, held, distributed, labeled, or licensed by the facility,” including the names and address of each facility and all trade names. This will most likely create record maintenance obligations for downstream manufactures and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers. According to Michael McGuffin, president of the American Herbal Products Association (AHPA), this “places new burdens on dietary supplements that are not required for any other class of food.”

In addition, the Dietary Supplement Safety Act of 2010 bill would change the “grandfather” status of dietary supplement products marketed in the U.S. prior to the Dietary Supplement Health and Education Act (DSHEA), before October 15, 1994. It instead establishes a list of “‘Accepted Dietary Ingredients’, to be prepared, published, and maintained by the Secretary,” and defines a new dietary ingredient as any ingredient not included on such list. Any substance not on the list would have to be submitted to the FDA 75 days before being used in a supplement with data supporting its history of use and safety.

The Government Accountability Office wants to extend the mandatory reporting of adverse event from the current serious adverse events to mild and moderate adverse events, with the manufacturer keeping records on all of them for a minimum of three years. The AHPA notes, “Marketers of conventional foods have no adverse event reporting requirements, even for serious adverse events.”

In addition, the GAO wants the FDA to have recall authority over supplement products, to order the cessation of distribution, notification of distributers, importers, retailers and consumers, of any product that is determined to cause serious, adverse health consequences or death, or is adulterated or misbranded. The problem here is that products could be considered adulterated if it has an ingredient not on the established list, or if the formula was changed or reformulated and the change was not registered or updated, even if this change does not present any hazard to the public. Herbs can vary in availability and quality and sometimes formulas are changed to maintain the overall effectiveness of the product. McCain’s bill includes monetary penalties for non-compliance with these regulations

What is of particular interest is the loss of supporters reported by Senator McCain’s office: Major League Baseball, the National Basketball Association, the National Football League, the National Hockey League, the United States Olympic Committee, the American College of Sports Medicine, National College Athletic Association, and the PGA Tour.

This gives the impression that what McCain is really trying to do is to curb the use of herbs and supplements that might have anabolic or performance enhancing effects and are currently “getting around” regulations.

References:

[1] GAO-09-250 January 29, 2009

[1] GAO-09-250 January 29, 2009

[1] http://ahpa.org/Portals/0/pdfs/10_0202_Dietary_Supplement_Safety_Bill.pdf

Wednesday, January 13, 2010

Colloidal Silver Banned Throughout the European Union

As of January 1, 2010, colloidal silver has been banned throughout the European Union. Colloidal silver can no longer be sold as a nutritional supplement in any health food store in the EU, and could, according to health freedom reports, meet a similar fate in the U.S. The health blog Colloidal Silver Secrets is expected to post a report on this ban, including information from European health freedom groups, soon.

According to the National Center for Complementary and Alternative Medicine (NCCAM) website, colloidal silver is typically marketed as a dietary supplement and consists of "tiny silver particles suspended in liquid." Silver has a medicinal history dating back centuries, though, according to NCCAM, "modern drugs have eliminated most of those uses." A handful of prescription drugs containing silver are still available, such as silver nitrate, which can be used for prevent conjunctivitis in newborn babies and certain skin conditions.

Colloidal silver is usually taken by mouth, although there are forms that can be sprayed, applied directly to the skin, or injected into a vein. However, the U.S. Food and Drug Administration (FDA) "does not consider colloidal silver to be safe or effective for treating any disease or condition." To learn more about dietary supplements and their regulation, check out the NCCAM Using Dietary Supplements Wisely page.

For more information about colloidal silver and health freedom, check out the article "Silver--Safe, Effective, Dangerous to Big Pharma" featured on the Health Freedom USA website.

We'd love to hear your thoughts and reflections about this ban. Please take a moment to post a brief comment. Thanks!

Image © iStockphoto.com, Donall O Cleirigh, http://health.howstuffworks.com/health-illness/wellness/natural-medicine/alternative-medicines/colloidal-silver.htm


Friday, September 4, 2009

Adverse Event Reporting for Registered Aromatherapists

BY Arianna Staruch, ND, ACHS Academic Dean

According to the FDA, a dietary supplement is a product intended to supplement the diet, which must be labeled as such and intended for ingestion. Ingredients in dietary supplements can include vitamins, minerals, herbs or botanicals, amino acids, dietary substances used to increase the entire dietary intake, concentrates, metabolites, constituents, extracts, or combination of these ingredients. If ingested, then, essential oils can be considered a dietary supplement and should be treated with the same precaution as more traditional supplements.

For that purpose, Registered Aromatherapists (RAs) should familiarize themselves with the new guidance information released by the FDA regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Though this Act does not require reports of adverse effects for foods other than dietary supplements, voluntary submission of reports of "serious adverse events associated with all FDA-regulated foods " are encouraged.

The FDA website defines an adverse event is considered "any health-related event associated with the use of a dietary supplement that is adverse." For RAs who use essential oils internally with their clients, reporting of any adverse events will not only increase general safety but will actively develop a database of current research to help the professional community better understand the potential effects and applications of botanical-based products.

To submit a report of a serious adverse event to the FDA, a MedWatch Form 3500A should be used. This form is also called a FDA Form 3500A. When submitting a form, the submitter is asked to include: an identifiable patient, an identifiable initial reporter, the identity and contact information for the responsible person, a suspect dietary supplement, and a serious adverse event or fatal outcome. (The FDA defines a 'serious adverse event' as one that results in a: death, life-threatening experience, inpatient hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an outcome previously listed that requires medical or surgical intervention to prevent.)

References:
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm

>> This article first appeared in the Aromatherapy Registration Council September 2009 newsletter. CLICK HERE to download the complete newsletter.

>> Read "Natural perfume making with essential oils" on the ACHS website

Tuesday, August 4, 2009

Soy fact vs soy fiction

The FDA has allowed the following claim to be made concerning soy products: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease.”

To qualify food must: Contain 6.25 G of soy protein, have less than 3 g fat and 1 g saturated fat, and less than 20 mg of cholesterol and less than 480 mg of sodium. This claim is based on whole soy protein food, not isolated soy constituents. Asian diets contain typically 6-11 g of soy protein/day, which includes 25-50 mg of isoflavones.

Soy is a complete protein. Not really, but that might not be a bad thing.

The FDA claims that soy protein can be a good substitute for animal protein because it contains all the necessary essential amino acids. Soy is high in the non-essential amino acids, but is low in cysteine, methionine, and lysine. However, soy protein, as well as many other vegan proteins, are higher in non-essential amino acids than most animal-derived food proteins, and as a result should preferentially favor glucagon production. (This could help with insulin resistance.)

An unnecessarily high intake of essential amino acids—as in high-meat diets—may prove to be as grave a risk factor for “Western” degenerative diseases as is excessive fat intake.

Soy prevents cancer. Maybe.

Soy contains isoflavones that are phytoestrogens, which may have both benefits and risks. Phytoestrogens interact with many receptors, including estrogen hormone receptors, but the type of interaction and the type of receptor dictates the biologic response. For instance genistein, one of the main soy isoflavones, interacts differently with estrogen receptor alpha and estrogen receptor beta. Genistein was shown to inhibit the growth of MCF-7 breast cancer cells.

Epidemiological studies show that women with traditional diets high in soy have a lower incidence of breast cancer those women with Western diets. There are no studies that show eating high amounts of soy later in life can decrease a women’s risk of breast cancer however.

Soy is safe for breast cancer survivors. Probably NOT.

Currently neither the animal data nor human data is conclusive as to whether soy is safe for breast cancer survivors. Women who are estrogen positive breast cancer survivors are frequently told to restrict their intake of soy products because of the phytoestrogen content.

GMO soy is healthy. If you don’t mind herbicides on your food!

Genetically modified soy is “Roundup Ready”, MEANING Roundup can be sprayed on the crop for weed control. Roundup Ready (RR) varieties of soybean has increased the use of glyphosate for weed control and glyphosate residues were found in soybean leaves and stems, and metabolites of the herbicide were found in the grain. Applications of glyphosate have no effects on phytoestrogen levels in glyphosate-resistant soybeans.

Fermented soy is better for you. Not really.

There is a difference in the isoflavones in non-fermented vs. fermented soy food, but the effect of enzymes and flora activity in the digestive tract makes the difference unimportant.

Soy is a common food allergen. True!

Soy is one of the top food allergens, along with cow’s milk, citrus, nuts, wheat, seafood and egg. Allergenicity of GMO soy may be altered. Hydrolyzed soy protein may not be as antigenic and there may be cross-reactivity with birch pollen and soy.

Soy inhibits the thyroid. Not True!

In 14 human studies, most found little change in thyroid function tests of normal subjects ingesting isolated soy protein. There are a few case studies of soy impacting hypothyroid patients, by reducing thyroid medication absorption. Always also consider iodine deficiency. Iodine deficiency lead to goiter and soy may make an iodine deficiency worse. An interesting not is that Asian soy consumption is often coupled with seaweed, which is naturally high in iodine.

Soy inhibits protein digestion. Possibly.


Raw soy contains Bowman-Birk (BBI) inhibitor of chymotrypsin and trypsin and the Kunitz inhibitor of trypsin (KTI). Heating and processing of the soybean removes most but not all of these inhibitors. On the other hand, several studies suggest that BBI can also function as an anticarcinogen, possibly through interaction with a cellular serine protease.

Soy is safe for infant formulas. Caution is needed.

Infants consuming soy formulas had 10 times higher isoflavone levels in their blood than women receiving soy supplements who show menstrual disturbances. Small, physiologically relevant phytoestrogen exposure levels can alter estrogen-dependent gene expression in the brain and affect complex behavior in a wide range of species. The implications for these findings in humans, and particularly in infants, largely remain uninvestigated but are a subject of increasing public interest.

Soy infant formulas contain BBQ and KTI, protein enzyme inhibitors; infants on soy formula consume about 10 mg of KTI plus BBI per day. The impact of reduced protein digestion due to these enzyme inhibitors in infants is not known.

Soy is a good food. Most likely.

Whole soy foods are a good source of fiber, B vitamins, calcium and omega-3 essential fatty acids. Replacing some high fat animal protein with soy foods is beneficial. Soy can be part of a healthy diet, along with fruits, vegetables, and whole grains, fish and lean meats Introduce soy slowly to the daily diet. Avoid if you have soy allergies.

Soy is a nutraceutical. Most likely.

Soy isoflavones may be helpful for modest cholesterol lowering effects. Soy isoflavones effect on breast cancer is unclear. Soy isoflavones may be helpful for menopausal symptoms. Soy isoflavones may be supportive for postmenopausal bone health.

>> By Dr. Arianna Staruch, ND, ACHS Dean of Admissions

Soy fact vs soy fiction

The FDA has allowed the following claim to be made concerning soy products: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease.”

To qualify food must: Contain 6.25 G of soy protein, have less than 3 g fat and 1 g saturated fat, and less than 20 mg of cholesterol and less than 480 mg of sodium. This claim is based on whole soy protein food, not isolated soy constituents. Asian diets contain typically 6-11 g of soy protein/day, which includes 25-50 mg of isoflavones.

Soy is a complete protein. Not really, but that might not be a bad thing.

The FDA claims that soy protein can be a good substitute for animal protein because it contains all the necessary essential amino acids. Soy is high in the non-essential amino acids, but is low in cysteine, methionine, and lysine. However, soy protein, as well as many other vegan proteins, are higher in non-essential amino acids than most animal-derived food proteins, and as a result should preferentially favor glucagon production. (This could help with insulin resistance.)

An unnecessarily high intake of essential amino acids—as in high-meat diets—may prove to be as grave a risk factor for “Western” degenerative diseases as is excessive fat intake.

Soy prevents cancer. Maybe.

Soy contains isoflavones that are phytoestrogens, which may have both benefits and risks. Phytoestrogens interact with many receptors, including estrogen hormone receptors, but the type of interaction and the type of receptor dictates the biologic response. For instance genistein, one of the main soy isoflavones, interacts differently with estrogen receptor alpha and estrogen receptor beta. Genistein was shown to inhibit the growth of MCF-7 breast cancer cells.

Epidemiological studies show that women with traditional diets high in soy have a lower incidence of breast cancer those women with Western diets. There are no studies that show eating high amounts of soy later in life can decrease a women’s risk of breast cancer however.

Soy is safe for breast cancer survivors. Probably NOT.

Currently neither the animal data nor human data is conclusive as to whether soy is safe for breast cancer survivors. Women who are estrogen positive breast cancer survivors are frequently told to restrict their intake of soy products because of the phytoestrogen content.

GMO soy is healthy. If you don’t mind herbicides on your food!

Genetically modified soy is “Roundup Ready”, MEANING Roundup can be sprayed on the crop for weed control. Roundup Ready (RR) varieties of soybean has increased the use of glyphosate for weed control and glyphosate residues were found in soybean leaves and stems, and metabolites of the herbicide were found in the grain. Applications of glyphosate have no effects on phytoestrogen levels in glyphosate-resistant soybeans.

Fermented soy is better for you. Not really.

There is a difference in the isoflavones in non-fermented vs. fermented soy food, but the effect of enzymes and flora activity in the digestive tract makes the difference unimportant.

Soy is a common food allergen. True!

Soy is one of the top food allergens, along with cow’s milk, citrus, nuts, wheat, seafood and egg. Allergenicity of GMO soy may be altered. Hydrolyzed soy protein may not be as antigenic and there may be cross-reactivity with birch pollen and soy.

Soy inhibits the thyroid. Not True!

In 14 human studies, most found little change in thyroid function tests of normal subjects ingesting isolated soy protein. There are a few case studies of soy impacting hypothyroid patients, by reducing thyroid medication absorption. Always also consider iodine deficiency. Iodine deficiency lead to goiter and soy may make an iodine deficiency worse. An interesting not is that Asian soy consumption is often coupled with seaweed, which is naturally high in iodine.

Soy inhibits protein digestion. Possibly.


Raw soy contains Bowman-Birk (BBI) inhibitor of chymotrypsin and trypsin and the Kunitz inhibitor of trypsin (KTI). Heating and processing of the soybean removes most but not all of these inhibitors. On the other hand, several studies suggest that BBI can also function as an anticarcinogen, possibly through interaction with a cellular serine protease.

Soy is safe for infant formulas. Caution is needed.

Infants consuming soy formulas had 10 times higher isoflavone levels in their blood than women receiving soy supplements who show menstrual disturbances. Small, physiologically relevant phytoestrogen exposure levels can alter estrogen-dependent gene expression in the brain and affect complex behavior in a wide range of species. The implications for these findings in humans, and particularly in infants, largely remain uninvestigated but are a subject of increasing public interest.

Soy infant formulas contain BBQ and KTI, protein enzyme inhibitors; infants on soy formula consume about 10 mg of KTI plus BBI per day. The impact of reduced protein digestion due to these enzyme inhibitors in infants is not known.

Soy is a good food. Most likely.

Whole soy foods are a good source of fiber, B vitamins, calcium and omega-3 essential fatty acids. Replacing some high fat animal protein with soy foods is beneficial. Soy can be part of a healthy diet, along with fruits, vegetables, and whole grains, fish and lean meats Introduce soy slowly to the daily diet. Avoid if you have soy allergies.

Soy is a nutraceutical. Most likely.

Soy isoflavones may be helpful for modest cholesterol lowering effects. Soy isoflavones effect on breast cancer is unclear. Soy isoflavones may be helpful for menopausal symptoms. Soy isoflavones may be supportive for postmenopausal bone health.

>> By Dr. Arianna Staruch, ND, ACHS Dean of Admissions

Monday, April 20, 2009

AHG Vice President Roy Upton leads TeleSeminar about FDA Good Manufacturing Practices

When the new GMPs for herbal products were finalized by the Food and Drug Administration (FDA) in June 2007, many breathed a sigh of relief: the FDA was not requiring practitioners who make their own products for their clients to adhere to the new regulations. The FDA did retain the authority, however, to do so in the future. This raises questions for herbalists, like “What would cause the FDA to come knocking" on an herbalist's door or to change their minds and require us to follow the guidelines?

There are few better people than Roy Upton to answer these questions or to discuss the ways to ensure that your clients are receiving high-quality herbal medicines.

Registration is open for the second installment in the 2009 AHG TeleSeminar Series. Roy Upton, AHG's Vice-President, will be speaking on "What Do the FDA Good Manufacturing Practices Mean for Herbalists" on May 4 at 7:00 p.m., EST.

Trained in both traditional Western and Chinese herbalism, Roy Upton is a founding and professional member of the American Herbalists Guild. His background includes extensive study with various Native American and non-Native herbalists, ethnobotany of the United States Virgin Islands, and seven years of clinical practice, followed by a three-year clinical internship with Michael Tierra and training at the Shanghai University of Traditional Chinese Medicine, Shanghai, China. He is the executive director and editor of the American Herbal Pharmacopoeia® and is also a member of the Standards Committee of the American Herbal Products Association.

In his "day job," Upton is general manager of Planetary Formulas. He writes extensively and is the author of St. John's Wort and Echinacea, as well as co-author of the Botanical Safety Handbook—a landmark text of herbal safety—and is currently active in the preparation of a new edition.

To register for the AHG TeleSeminar, call the AHG Office at (203) 272-6731 or visit: http://americanherbalistsguild.com/node/132.

Friday, April 10, 2009

We know to filter water. But should we be filtering our cosmetics too?

Hormone-altering chemicals in your makeup? Could be. The FDA does not require cosmetics manufacturers to test their own personal care products for safety. And yet, we buy it. We think...Chapstick can't hurt. It's just shampoo. But studies are showing that a little of something used over a long period of time can, in fact, hurt your overall health and wellness.

Ever wondered what those long, garbled words ("ingredients") on the back of your personal care products mean? They're synthetics. You probably new that. But...what do they mean? The skin is a complicated organ, one that needs clear pathways to excrete toxins. Synthetics block the skin's pathways, which, to the average eye, looks like less-than-vibrant skin.

To help you sort the good (natural!) from the bad and the ugly (synthetic), the Environmental Working Group has launched Skin Deep, a cosmetics safety database where you can search the products you use on a daily basis by product name, ingredient, or company. For example, did you know that Pantene Conditioning Spray has a hazard rating of 10 out of 10. Ingredients in this product have been linked to: developmental and reproductive toxicity, violations, allergies, and organ system toxicity, to name a few. Burt's Bees Avocado Hair Conditioner, however, only has a toxic rating of 3, which reflects its link to allergies.

Don't be fooled the word "cosmetics." We're not talking lipstick and sparkle eyeshadow here (not only). Toxic ingredients are equally included in men's and women's personal care products. For example, AXE Deodorant Body Spray for Men has a hazard rating of 5, while BOD MAN Fragrance has a rating of 8.

The decision to protect your health is a personal one. Make the most of it. Choose natural. For more information about natural products, download free tips and recipes from the Apothecary Shoppe College Store.

Monday, March 23, 2009

Major food safety reforms would be would be gr-r-reat

ACHS Master Herbalist Christina Suarez, owner of The Good Herb Company, led a talk at ACHS Saturday, March 21, about Organic Standards. While outlining the extensive requirements for organic certification, Suarez emphasized the importance of reading food labels to evaluate the health benefits of ingredients. As part of her presentation, Suarez talked about a recent news article in which the CEO of Kellogg calls for a food safety reform program. On principle, it just sounds like a good idea. But, on a practical level, it’s essential because, as Suarez pointed out, many of the foods we have been eating for years are GMO (a genetically modified organism), which many people don’t know.

Here is an excerpt of the article “Kellogg’s CEO calls for major food safety reforms” from the Associated Press, March 18.

“Tony the Tiger's boss says a food safety overhaul would be Gr-r-reat!
The Kellogg Co.’s top official is urging U.S. legislators to revamp the food safety system. The world's biggest cereal maker—its brands include Frosted Flakes—lost $70 million in the recent salmonella outbreak, after recalling seven million cases of peanut butter crackers and cookies.

CEO David Mackay will tell Congress on Thursday [March 19] the company wants food safety placed under a new leader in the Health and Human Services department. He also calls for new requirements that all food companies have written safety plans, annual federal inspections of facilities that make high-risk foods and other reforms.

Mackay’s strong endorsement of major changes could boost President Barack Obama's efforts to overhaul the system. Last week, Obama launched a special review of food safety programs, which are split among several departments and agencies and rely in some cases on decades-old laws. Critics say more funding is needed for inspections and basic research.

"The recent outbreak illustrated that the U.S. food safety system must be strengthened," Mackay said.

"We believe the key is to focus on prevention, so that potential sources of contamination are identified and properly addressed before they become actual food safety problems."

In addition to health prevention and safety, there are several reasons to avoid GMO-grown foods, however used to eating them we are. Here are a few:

1. Sustainability agriculture supports local food growing (like your favorite farmer’s market)
2. Environmental preservation
3. Taste. Non-GMO foods have it!

Click here to read more about Christina Suarez and The Good Herb Company.

To learn more about David Mackay’s presentation to Congress March 19, click here.

What do you know about GMO? Tell us below. Label-reading tips? We want to know those too.

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