Table of Contents > Alternative Modalities > Herbal product design and development Print

Herbal product design and development

Image

Also listed as: Diet, Zone
Related terms
Background
Theory/evidence
Safety
Author information
Bibliography
Herbal product regulations and formulation process

Related Terms
  • Adequate protein diet, Barry Sears, carbohydrate, diet, fat, low carbohydrate diet, protein.

Background
  • The Zone diet is an unproven dietary regime, which has been popularized by Dr. Barry Sears through sales of his 1995 book, The Zone. Despite claims made in the book, there is little available research to support its overall benefit.
  • The Zone diet is a calorie-restricted diet that provides adequate protein, moderate levels of carbohydrates, essential fats and micronutrients spread through three meals and two snacks that approximately maintain the protein-to-carbohydrate ratio throughout the day.
  • Proponents believe that the Zone diet promotes optimal metabolic efficiency in the body by balancing the hormones insulin and glucagon. Insulin is responsible for converting, in the blood, incoming nutrients into cells. Glucagon regulates glucose in the liver. Overall, the Zone's food plan consists of a dietary intake of 40% carbohydrates, 30% protein and 30% fat.
  • Under this diet, recommended foods include fruits and vegetables (fresh or frozen), oatmeal (whole grain), protein powder (e.g. soybean isolate), chicken, turkey, lean beef, fish, low-fat cottage cheese, soy food, nuts (e.g. almonds, cashews, macademia, pistachios), extra virgin olive oil, natural sweeteners, such as fructose or stevia.

Theory / Evidence
  • Recent research seems to indicate that a low total caloric intake is associated with longer life expectancy. Based on animal studies, animals eating calorie-restricted diets may live 1.5 to 2 times as long as animals eating high-calorie diets. Theoretically, similar effects may occur in humans. The caloric restriction recommended by the Zone diet is below that of the average American and may be of benefit in weight loss and if maintained over decades in increasing life expectancy. On the other hand, athletes in training will likely suffer from decreased performance if restricted to the low calorie diet recommended by the Zone.
  • Despite proposed benefits, currently there are no high quality clinical trials available about the Zone diet or similar diets consisting of the recommended 40% carbohydrates, 30% fat, and 30% protein. The Zone diet is quite complex in terms of caloric restriction, ratio of carbohydrates/protein//fat, spacing of meals, preferential intake of certain fats, and avoidance or inclusion of a few specific foods.

Safety




Author information
  • This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Bibliography
  1. Cheuvront SN. The zone diet and athletic performance. Sports Med. 1999;27(4):213-228.
  2. Natural Standard: The Authority on Integrative Medicine.
  3. Sears B. The Zone Diet and athletic performance. Sports Med. 2000;29(4):289-294.

Herbal product regulations and formulation processes
  • GMP (Good Manufacturing Practices): The National Nutritional Foods Association (NNFA), the herb and supplement industry's largest trade association, has run a program since 2002 that examines products and factory conditions of member companies. The NNFA provides this service because the U.S. Food and Drug Administration (FDA) does not regulate these products as stringently as pharmaceutical drugs. Member companies who pass the inspection receive the right to display the GMP (Good Manufacturing Practices) seal of approval on their products. The GMP seal represents adequate NNFA standards of quality control in manufacturing and distribution of the herb or supplement product.
  • The FDA is authorized to issue GMP regulations describing conditions under which dietary supplements must be prepared, packed, and stored. The FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in properly formulated dietary supplements and that dietary supplements are accurately labeled. GMPs are primarily concerned with safety and sanitation rather than dietary supplement standardization. Some herbal product manufacturers voluntarily follow pharmaceutical drug GMPs, which are more rigorous than GMPs for dietary supplements, but they are not required to do so.
  • Standardization: Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (known as chemical markers) that can be used to manufacture a consistent product. If the chosen markers are present at about the same amounts between batches of the same product, then it is likely that all of the ingredients in that product are present in equal proportions between these batches. This process provides a measure of quality control.
  • Standardization is achieved by choosing at least one chemical compound present in the herb or supplement and monitoring its concentration in each batch of product. Batches that do not meet the standard are modified accordingly. Standardization is not directly related to efficacy because it does not assess the total chemical composition of the product; rather, it only indicates consistency of contents. Further, consistency of contents is a separate measure from clinical efficacy.
  • Previously, a legal or regulatory definition for the standardization of dietary and herbal supplements did not exist in the United States. Due to this, some manufacturers may use the term incorrectly to refer to uniform manufacturing practices, such as mixing equal proportions of several plant parts. However, mixing plants in equal proportions may not yield identical final products because the constituents of a plant may vary between batches. Therefore, following a recipe of proportions or similar procedures is not sufficient for a product to be considered standardized. As a result, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.
  • The legal status of herbal ingredients varies by country.
  • Dosage: Dosage is in general a crucial issue for herbal products. While most pharmaceutical drugs are extensively tested to determine the most effective and safest dosages (especially in relation to patient variables such as body weight, other medications, and allergies), there are few established dosage standards for herbal products. Generally, the dosages recommended for a dietary or herbal supplement may vary, and the exact therapeutic range is not well known. Experts in the field of complementary and alternative medicine may not agree upon the minimum and maximum dose needed for clinical efficacy.
  • Product label claims: Previously, the FDA regulated dietary and herbal supplements as foods. Knowledge of the clinical efficacy of substances classified as foods was not necessary for a product to be sold. This meant that dietary supplements did not have to meet the same standards as pharmaceutical drugs and over-the-counter medications for proof of safety, effectiveness, and Good Manufacturing Practices (GMPs). Most often, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in accompanying literature although many food and dietary supplement product labels do not include this information.
  • Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.
  • The label of a dietary supplement or food product may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a food, food component, or dietary supplement ingredient and the reduction of risk for disease or health-related condition. Nutrient content claims describe the relative amount of a nutrient or dietary substance in a product in grams or ounces. A structure/function claim is a statement describing how a product may affect organs or systems of the body, and it cannot mention that it may treat, prevent, or cure any disease. Structure/function claims do not require FDA approval, but the manufacturer must provide the FDA with the text of the claim within 30 days of product release on the market. Product labels containing such claims must also include a disclaimer that reads, "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Dietary supplements are not required to state any health claim on their packaging.
  • The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, then the FDA may remove the product from the marketplace. Additionally, the Federal Trade Commission (FTC) regulates the advertising of herbal products.
  • The FDA has also implemented a requirement that dietary herbs and supplements must list the parts of the plant used in a product. Some products also include a very abbreviated form of nutrition information.
  • In response to the overwhelming interest in the Internet, the FDA is looking at policy issues that address the type of information being placed on websites and the regulations that may need to be implemented in this area.
  • Safety regulations: In addition to regulating label claims, the FDA regulates dietary supplements in other capacities. Supplement ingredients sold in the United States before October 15, 1994 are not required to be reviewed by the FDA for their safety before they are marketed because they are presumed to be safe based on their history of use. These older supplements are not required to present any evidence of clinical safety; the lack of reports on adverse effects is considered sufficient. For a new dietary ingredient (one not sold as a dietary supplement before 1994) the manufacturer must notify the FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product. The evidence of safety for safe human use varies considerably between different products. The FDA can either refuse to allow new ingredients from entering the marketplace or remove existing ingredients for safety reasons.
  • For herbs and supplements, once a dietary or herbal supplement has been marketed, the FDA has to prove that the product is not safe in order to restrict its sales or order that the product be removed from market. In contrast, for pharmaceutical drugs, manufacturers must obtain FDA approval by providing convincing evidence that the drug is both safe and effective before being marketed. Herbs and supplements are often presumed safe until proven otherwise, whereas drugs are not.
  • The issue of regulation is an area of continuing controversy in the European Union and the United States. At one end of the spectrum, some integrative medicine practitioners such as herbalists maintain that many traditional herbal remedies have a long history of use and do not require the level of safety testing as pharmaceutical drugs or isolated plant constituents (single plant ingredients in an artificially concentrated form). On the other hand, some healthcare providers are in favor of legally enforced quality standards, safety testing, and prescription by a qualified practitioner. Some professional herbalist organizations have made statements calling for a specialized category of regulation specifically designed for herbal products.
  • However, herbal remedies prescribed and dispensed either by an herbalist or a naturopathic physician (ND) are regulated as medicines. In order to obtain large amounts of herbs from a distributor, many companies require documentation of the practitioner's certification by a government body or advocacy organization.
  • Raw materials validation: The chemical and herbal contents of a product may vary for a variety of reasons. For instance, natural botanical variations may exist between batches of herbs, and variations in manufacturing standards and practices may also alter the levels of plant chemicals and therefore the potential overall quality and medicinal efficacy of an herbal product.
  • Species variation due to genetics may affect the proportions of constituents in the product. Factors such as growth and reproduction may influence the plant's state of development when it is harvested for medicinal use. Plant parts, such as the stems, leaves, fruits, roots, and flowers may vary in their potency for medicinal applications. Thus, selection of which plant parts are used will affect the chemical composition of the final product. Finally, the environment in which the plant was grown may vary from season to season. Examples of environmental variation include the temperature, rainfall, day length, altitude, atmospheric composition, and soil quality.
  • Manufacturing processes: Variations in the manufacturing processes of an herbal product, such as drying and storage, might also affect its quality and medicinal efficacy. Drying factors include the time between collection and drying, the time allowed for drying, and the temperature used for drying. Storage may also affect the quality of the product as well, as moisture reabsorption and loss of volatile oils may occur during the storage process. Additionally, an herbal product may be inadvertently sterilized or may be infected with molds, bacteria, or insects during storage. Possibilities for adulteration include the mishandling of the product, and harvesting other plants or plant parts not intended for use in the final product.
  • Delivery systems: Extraction procedures also have a significant effect on the quality and medicinal efficacy of the product. These factors include the type of solvent used, the amount of plant material exposed to the solvent, the degree of agitation, the temperature used during extraction, and the exposure of the solvent and herb to oxygen and light.

Copyright © 2011 Natural Standard (www.naturalstandard.com)


The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

62 Marshall St
Rochester, NY 14607
585-454-2667
585-454-0343 (fax)
Email Our Store
Driving Directions

  STORE HOURS
 Mon8:00am-8:00pm
 Tue8:00am-8:00pm
 Wed8:00am-8:00pm
 Thu8:00am-8:00pm
 Fri8:00am-8:00pm
 Sat9:00am-7:00pm
 Sun10:00am-7:00pm
 

Co-op Connections

Follow us on Instagram!

Follow us on Twitter!

Join our Facebook community!

Email newsletter sign up

Email Newsletter Archive
Click here>>

Download The Rutabaga Rap

Rutabaga Rap Archive
Click here>>

About Our Co-op

Current Job Openings
See current openings>>

Top 10 Reasons for Shopping
Learn more>>

Why become an owner?
Learn why>>

Owner Application
Download (pdf)>>

All About Co-ops
Learn more>>

Our Board of Directors
Learn more>>

Global Ends Policy
Learn more>>

Bylaws
Learn more>>

Advertise in Our Newsletter
Learn more>>

Job Application
Download (pdf)>>

Discover your local co-op!