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

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.

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  • How would the FDA draft guidance on NDIs--if it is not amended--affect your business and the kind of products that you sell?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.

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

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?".

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!

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.

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/

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


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
 
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