USING HERBS & SUPPLEMENTS

SAFELY

Presented by:

APOTHECARIAN HERBALS, LLC

3430-D Anderson Hwy. (Rt. 60), Powhatan, VA  23139

Ph: (804) 598-5352

www.herbalconsultant.com

STATISTICS ABOUT HERBAL SAFETY

“As you needle the safe herbs and pick on the supplements today, remember that even with AMA, CDC, and FDA help, you can't come up with 100 deaths a year in the United States due to herbs and supplements. Writing for US News & World Report, Amanda Spake reports about 20 deaths per year (Spake, 2001). Guy Gugliotta, staff reporter for the Washington Post, reports about 37 (Gugliotta, 2000).

Then remember that pharmaceuticals are now responsible for 218,000 deaths a year, at least according to an official publication of the American Pharmaceutical Association (English, 2001).

The herb busters should always cite both sets of statistics. Somehow they always forget to mention the lethality of pharmaceuticals.”

- Jim Duke, Ph.D., Former ecologist with the FDA, PhD in Botany from University of North Carolina, Author of numerous books about herbs including The Green Pharmacy, Duke Press.

According to statistics from the FDA

[      You’re 268 times more likely to get food poisoning,

[      And 255 times more likely to react to a prescription OR over the counter drug…

than you are to have an adverse reaction to a dietary supplement or herb.

            [from STOP (Safe Tables our Priority), U.S. Food and Drug Administration]

  [    In 2001, the FDA received 1,214 of adverse events (which may not necessarily be caused by the product) regarding dietary                   supplements or herbs.

  [    Comparatively, the FDA received more than 300,000 adverse reports about drugs.

WHY DO WE USE HERBS AND SUPPLEMENTS?

Much of today’s food is grown under unnatural circumstances.  The soil and plants are treated with chemicals, crops are not methodically rotated and the soil becomes depleted of all minerals and nutrients.  Animals bred for meat eat genetically modified, chemically treated grain and are given hormones and antibiotics.  As a society, people in the Western world in particular are eating processed, modified and synthesized food.  It is impossible to get enough nutrition unless one eats 100% organic foods and meats.  Those are difficult to obtain, but worth it when available.  The only way to guarantee we’re getting enough vitamins and minerals is through supplementation.

Most drugs today are being rushed to market with minimal testing and no long-term studies are being done on them. Doctors are writing prescriptions without even checking to see what other medications people are taking (this happened to my mother-in-law who has Alzheimer’s disease!).  Serious side effects of prescription drugs are discovered daily.  Doctors spend less than 15 minutes with each patient, not giving them enough time to ask one question, much less have a meaningful discussion about nutrition and disease prevention.  We medicate our children for everything. Now they have lowered immunity to bacteria and viruses from antibiotic overuse and they’re learning that even bad grades can be “cured” with a dose of Ritalin or Adderall.  Because of all this, people are turning to natural means of dealing with many health issues, particularly non-life threatening ones, like arthritis, digestive disorders, menopause, PMS and mild to moderate depression, to name just a few.

GENERAL GUIDELINES

Our bodies absorb & utilize all nutrients differently.  Some vitamins are fat-soluble and should be taken with food (A, D, E).  Iron is absorbed better when taken with meals and with foods containing Vitamin C.  Calcium needs magnesium to be absorbed.  And some vitamins work together to enhance each other’s benefits.  For example, biotin and B vitamins with C help metabolize proteins.

Supplements are generally safe when consumed in the appropriate dosages. But remember - more isn't necessarily better—and sometimes it can be worse. For example, the mineral selenium is recommended for many disorders, from cataracts to cancer prevention. But taking doses even slightly higher than those recommended can cause loss of hair and other toxic reactions. When using supplements, it's a good idea to avoid high doses, particularly extremely high ones, unless being monitored by a health professional.

VITAMINS

Most vitamins can be taken in significantly higher doses than the FDA’s required daily allowances (RDA)  without producing adverse reactions. However, a few fat-soluble vitamins, could be toxic at high doses. Vitamins A and D are examples. Some people could be susceptible to high doses of water-soluble vitamins such as vitamin C. Reducing the dosage can usually remedy the situation. Some minerals, taken in large doses or over time, can block the absorption of other minerals. Zinc, for instance, can impede copper absorption. Too much iron in men, for example, increases their risk of heart disease. 

HERBS

According to most experts in pharmacology and toxicology, serious side effects or toxic reactions associated with herbal medicines are rare.  Occasionally, some people exhibit serious allergic reactions to an herb, which may include hives or difficulty in breathing.  In addition, using some herbs for medicinal purposes can be risky for people with certain health conditions or for those on particular medications (see chart that follows). Some herbs take a long period of time to cause a reaction.  Always follow dosage recommendations closely and notify your doctor at once if your condition worsens or if any serious adverse reactions develop.

PREGNANCY

While there are many safe and beneficial herbs for pregnancy (red raspberry leaf being the best), all pregnant women should avoid using any strong herbs. This includes, but isn’t limited to: goldenseal, barberry and Oregon grape root; laxatives such as senna and cascara sagrada; and coffee, kola nut and guarana, all of which contain caffeine. Herbs that affect hormones, like dong quai and fenugreek, and uterine stimulants such as aloe, fenugreek and rue should be strictly avoided unless recommended by an herbal professional.  Herbs that react like aspirin (willow and meadowsweet) should only be used sparingly.  There are a few herbs that are used in the last weeks of pregnancy to help prepare the uterus for childbirth (black and blue cohosh), but shouldn’t be used without guidance.

HERB AND SUPPLEMENT REGULATION

Contrary to what the drug companies and media would have you believe, herbs and supplements are regulated by the FDA.  The Dietary Supplement and Health Education Act was passed in 1994.  It requires that all supplements must meet many of the safety guidelines required of any other food or additive.  According to the FDA, the law acknowledges that there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.  (An FDA explanation of the law is at the very end of this document.)

RULES OF THUMB

Here are some rules of thumb for how and when to safely take herbal medicines. Always check with a qualified health practitioner before taking an herbal supplement.

*Do not exceed recommended dosages.

 *Consult a healthcare professional when using herbal remedies in conjunction with pharmaceuticals or over the counter medications.

  *If side effects develop, stop taking herbal remedies and consult a healthcare professional.

*Do not use herbal remedies during pregnancy and/or lactation unless under the guidance of a healthcare professional.

*Only give herbal remedies to infants or young children under the guidance of a healthcare professional.

*Pay close attention to recommended dosages for different herbs and supplements and properly adjust dosages for children, elders and those with weak constitutions.  A trained herbalist or alternative practitioner can provide guidance.

*Many herbal teas and herbs in food are safe for daily use over time, but stronger forms of herbs (like tinctures) should not be used for more than brief periods without a trained herbalist's or alternative practitioner’s supervision.

*If you have a chronic medical condition, only use herbs and supplements under the supervision of a trained herbalist or healthcare practitioner.

*ALWAYS BE HONEST WITH YOUR DOCTOR!  Without knowing everything you’re taking, a physician could inadvertently prescribe something that could have an adverse interaction.

CONCLUSION

Herbal remedies and supplements are completely safe when used as directed.  It is the user’s responsibility to inform their healthcare professional about what drugs and supplements they take, particularly a few weeks prior to surgery.  Often the interactions are not listed on drug or supplement labels.  BECOME INFORMED!  And when in doubt, please ask!

REFERENCES

“Guidelines for Using Herbs Safely,” Healthwell, www.healthwell.com, accessed September 13, 2003.

“Second Thoughts on Dietary Supplement Safety?  Think Again,” NNFA Today, Volume 17, No. 7, July, 2003.

“Using Herbs and Essential Oils Safely,” Mother Nature.com Library, www.mothernature.com, accessed September 13, 2003.

“Using Supplements Safely and Effectively,” Magic of Ayurveda Library, www.magicofayurveda.com, accessed September 13, 2003.

U.S. Food and Drug Administration, “FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements,” backgrounder, March 7, 2003 (as reported by NNFA Today, Volume 17, No. 7, July 2003). www.fda.gov/bbs/topics/NEWS/dietarysupp/background.htm

U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Financial Management, “Human Drugs,” report (2002) (as reported by NNFA Today, Volume 17, No. 7, July 2003). www.fda.gov/oc/oms/ofm/budget/2002/CJ2002/HTML/CDER.htm#3/

U. S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

December 1, 1995

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

For decades, the Food and Drug Administration regulated dietary supplements as foods, in most circumstances, to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. An important facet of ensuring safety was FDA's evaluation of the safety of all new ingredients, including those used in dietary supplements, under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, with passage of the Dietary Supplements Health and Education Act of 1994 (DSHEA), Congress amended the FD&C Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result of these provisions, dietary ingredients used in dietary supplements are no longer subject to the premarket safety evaluations required of other new food ingredients or for new uses of old food ingredients. They must, however, meet the requirements of other safety provisions.

Signed by President Clinton on October 25, 1994, the DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress's intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.

The provisions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; require ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations. The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health.

These specific provisions of the DSHEA are synopsized below.

DEFINITION OF DIETARY SUPPLEMENT

FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added "herbs, or similar nutritional substances," to the term "dietary supplement." Through the DSHEA, Congress expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

The DSHEA established a formal definition of "dietary supplement" using several criteria. A dietary supplement:

is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

is intended for ingestion in pill, capsule, tablet, or liquid form.

is not represented for use as a conventional food or as the sole item of a meal or diet.

is labeled as a "dietary supplement."

includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

SAFETY

The DSHEA amends the adulteration provisions of the FD&C Act. Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions). A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) may be adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury. The Secretary of HHS may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety. However, like any other foods, it is a manufacturer's responsibility to ensure that its products are safe and properly labeled prior to marketing.

  LITERATURE

The DSHEA provides that retail outlets may make available "third-party" material s to help inform consumers about any health-related benefits of dietary supplements. These materials include articles, book chapters, scientific abstracts, or other third-party publications. These provisions stipulate that the information must not be false or misleading; cannot promote a specific supplement brand; must be displayed with other similar materials to present a balanced view; must be displayed separate from supplements; and may not have other information attached (product promotional literature, for example).

  NUTRITIONAL SUPPORT STATEMENTS

The DSHEA provides for the use of various types of statements on the label of dietary supplements, although claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (unless approved under the new drug provisions of the FD&C Act). For example, a product may not carry the claim "cures cancer" or "treats arthritis." Appropriate health claims authorized by FDA--such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis--may be made in supplement labeling if the product qualifies to bear the claim. Under DSHEA, firms can make statements about classical nutrient deficiency diseases--as long as these statements disclose the prevalence of the disease in the United States. In addition, manufacturers may describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Unlike health claims, nutritional support statements need not be approved by FDA before manufacturers market products bearing the statements, however, the agency must be notified no later than 30 days after a product that bears the claim is first marketed.

INGREDIENT AND NUTRITION INFORMATION LABELING

Like other foods, dietary supplement products must bear ingredient labeling. This information must include the name and quantity of each dietary ingredient or, for proprietary blends, the total quantity of all dietary ingredients (excluding inert ingredients) in the blend. The label must also identify the product as a "dietary supplement" (e.g., "Vitamin C Dietary Supplement"). Labeling of products containing herbal and botanical ingredients must state the part of the plant from which the ingredient is derived. If a supplement is covered by specifications in an official compendium and is represented as conforming, it is misbranded if it does not conform to those specifications. Official compendia include the U.S. Pharmacopeia, the Homeopathic Pharmacopeia of the United States, or the National Formulary. If not covered by a compendium, a dietary supplement must be the product identified on the label and have the strength it is represented as having.

Labels also must provide nutrition labeling. This labeling must first list dietary ingredients present in "significant amounts" for which FDA has established daily consumption recommendations, followed by dietary ingredients with no daily intake recommendations. Dietary ingredients that are not present in significant amounts need not be listed. The nutrition labeling must include the quantity per serving for each dietary ingredient (or proprietary blend) and may include the source of a dietary ingredient (for example, "calcium from calcium gluconate"). If an ingredient is listed in the nutrition labeling, it need not appear in the statement of ingredients. Nutrition information must precede ingredient statements on the product label.

 NEW DIETARY INGREDIENTS

Supplements may contain new dietary ingredients--those not marketed in the United States before October 15, 1994--only if those ingredients have been present in the food supply as an article used for food in a form in which the food has not been chemically altered or there is a history of use, or some other evidence of safety exists that establishes that there is a reasonable expectation of safety when the product is used according to recommended conditions of use. Supplement manufacturers must notify FDA at least 75 days before marketing products containing new dietary ingredients, providing the agency with the information on which the conclusion that a dietary supplement containing the new dietary ingredient "will reasonably be expected to be safe" was based. Any interested party, including a manufacturer of a dietary supplement, may petition FDA to issue an order prescribing the conditions of use under which a new dietary ingredient will reasonably be expected to be safe.

 GOOD MANUFACTURING PRACTICES (GMPs)

DSHEA grants FDA the authority to establish GMP regulations governing the preparation, packing, and holding of dietary supplements under conditions that ensure their safety. These regulations are to be modeled after current good manufacturing practice regulations in effect for the rest of the food industry. FDA intends to work with the supplement industry and other interested persons to develop GMPs and, in doing so, will seek public comment as to their scope.

 COMMISSION ON DIETARY SUPPLEMENTS

The DSHEA requires the formation of a Commission to conduct a study and make recommendations on the regulation of label claims and statements for dietary supplements and procedures for the evaluation of the claims. The members of the Commission will evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that they can make informed and appropriate health care choices. The Commission will be composed of seven members, appointed by the President, with experience in dietary supplements and in the manufacture, regulation, distribution, and use of supplements. Three members must be qualified by scientific training and experience to evaluate supplements' health benefits, and one of these must be trained in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. All Commission members and staff should be unbiased about supplement use.

On October 2, 1995, the White House announced the names of the seven individuals the President intends to appoint to the Commission. The members include nutritionists, industry representatives, a pharmacognosist, and attorneys.

The Commission will submit a final report including recommendations and legislation related to label claims for dietary supplements to the President and Congress within two years of convening.

OFFICE OF DIETARY SUPPLEMENTS

The HHS Secretary will establish an office within the National Institutes of Health to explore the potential role of supplements to improve health care in the U.S. The office will also promote scientific study of supplements and their value in preventing chronic diseases; collect and compile scientific research, including data from foreign sources and the NIH Office of Alternative Medicine; serve as a scientific adviser to HHS and FDA; and compile a database of scientific research on supplements and individual nutrients.

EFFECTIVE DATE

DSHEA's provisions for use of nutritional support statements and third-party literature became effective when the law was signed. The effective date for other labeling provisions and any FDA implementing regulations is after December 31, 1996, although manufacturers may label their products consistent with provisions of DSHEA until that date.

http://vm.cfsan.fda.gov/~dms/dietsupp.html

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