Growing and Using Moringa, Comfrey, and Healing Herbs

Learn how to grow and use Moringa Trees, Comfrey, medicinal herbs, adaptogen herbs such as Jiaogulan, and herbal medicine to create vibrant health and an enriched life style. There are a number of herbs you can grown at home which is fun and great for your health. Learn Tips on feeding your pets and livestock naturally with organic greens such as Comfrey, Kudzu, plantain, and Moringa. Get back to your roots in a healthy way.

Sunday, August 12, 2012

Why Don't I Sell My Own Moringa Powder?

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I have had several reader emails on this subject so here is the answer.  



 Nothing is simple in the US.  Moringa leaf production must be grown, picked, washed, dried, and packaged under regulations........

#1   You must have many acres of land with good drainage and water. It must be in an area that does not freeze to grow it year round. That is found in only a few areas of the United States such as Florida, Hawaii, and San Diego -LA areas.  Most of the other states get freezes which kills the Moringa Tree.  It grows best at sea level to 1500 feet which is only found in the states above too. So Moringa is an Asian tree that needs specific climate requirements to grow well.   These climate requirements are only found in a few areas

We moved to Nevada which is 4300 feet, no humidity, horrible winds, and just not a climate zone where you can plant them outdoors. My trees are kept in the house in 33 gal trash cans on wheels with a hard saucer to catch drainage.  I have a few that are now about 4 to 5 feet high.  They will stay in the house when winter hits in two months.  We get temps down to 0 some years here and snow.  So here in Nevada you grown and maintain them in the house or greenhouse. 


#2  You must have a hundred acres of trees at least to have enough to sell.  It takes a lot of leaves, when dried, to make up a pound. Most areas of the US because of water costs and regulations, are too expensive to grow enough trees to sell.  Most growers have to buy product from other countries to supplement what they cannot produce themselves. There are a few plantations in production now, that in the future may provide product in enough quanity to supply US buyers.


#3   Let us say, you have the Moringa trees growing in your area...enough to begin selling the leaves and pods.

Understand, that the pods contain the seeds you need to keep planting your own Moringa trees for the future. Most growers do not sell their own seed, because they use it to replant. It takes several years of production to have enough seeds to sell.

Once You Cut the Leaves...........Acres of Rules and Regulations


Once you cut the leaves off the tree you are subject to pages of rules and regulations by the local health department, the FDA, and your  state's local agricultural laws.   You cannot just sell the leaves.

You are supposed to have a business license, a nursery license, health certificate, fire inspection, inspections by the local agricultural agency to make sure your trees are free of disease and bugs.  Once you cut the leaves for resale, you must get a health permit for your business and where you hold the leaves after picking them. It cannot be at your home.

You must rent a specific building to house the product that is inspected by the health dept. It must pass many rules for cleanliness, temperature, and much more.  You and your employees must have a health permit to handle the product. The reason for that is so that they know your employees do not have TB or other diseases that can be spread by handling the product. They must ensure you are using the proper steps such as hand washing and gloves, so that customers do not get sick.

You must pass inspections on your companies procedures involving washing and drying the leaves properly. This is where the product may become contaminated with mold, mildew or bacteria.  If the leaves are not dryed quickly at low heat, they will and often do become contaminated.

This is an extremely critical part of Moringa or herb processing that can make a nutritious product into a contaminated-nutritionally empty product.  How is the dried product stored?  Is the room and equipment clean? There are many more factors to consider at this point.

You have two choices:  


Ship the product to a FDA -GMP compliant lab to test the product and bottle it within the law

or do it yourself.

Today by the GMP law, small companies must adhere to the GMP rules just like the big companies.

 It can cost $50,000 and more to comply to these rules.  So most small businesses cannot afford that.

They either are operating under the laws below or they send it to a lab that is certified by the state to package the raw product.   There are thousands of small companies right now, still operating under the radar of the GMP laws.  The inspectors have not gotten to them yet.

Read some of this below copied from the FDA site:  You will have a headache with just this much below. That is why herbs and supplements cost more there than from foreign countries. You must research the company that manufactures the product to know if it is GMP compliant. The bottle will not tell you. You must research the company to know what tests they perform on their products to ensure their safety and yours.  The bottle gives you only certain information.....not enough to know how good the product is.

I will sign off here but please read the GMP part below....you need to understand what your herb product goes through and why it costs so much.  The cheap products often have just the min testing done or they may be one of the companies that are operating at this point under the GMP radar. 


Here is one short part of the GMP Rules found here 

There are many pages of rules and regulations to conform to ...all costing money and time.   


Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

Contains Nonbinding Recommendations
December 2010
Small Entity Compliance Guide

You may submit either electronic or written comments regarding this guidance at any time. Submit electronic comments to http://www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies are available from:
Office of Nutrition, Labeling, and Dietary Supplements
Division of Dietary Supplement Programs, HFS-810
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park,, MD 20740
(Tel) 301-436-2375 (Updated phone: 240-402-2375)
http://www.fda.gov/FoodGuidances


U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 2010

Contains Nonbinding Recommendations

Table of Contents

  1. Introduction
  2. Discussion
    1. Compliance Dates for the Dietary Supplement Current Good Manufacturing Practice Rule (DS CGMP Rule) and the Interim Final Rule
    2. Organization for the DS CGMP Rule
  3. Subpart A – General Provisions
    1. Coverage of the DS CGMP Rule
    2. How the DS CGMP Rule Applies to Specific Types of Operations
    3. How the DS CGMP Rule Applies to Contractors
    4. Terms Used in the DS CGMP Rule and In This Document
    5. Other Applicable Statutory Provisions and Regulations
  4. Written Procedures Required by the DS CGMP Rule
  5. Records Required by the DS CGMP Rule
  6. Subpart B – Personnel
  7. Subpart C – Physical Plant And Grounds
  8. Subpart D – Equipment And Utensils
  9. Subpart E – Requirement To Establish A Production And Process Control System
    1. General Requirements of Subpart E
    2. Requirements to Establish Specifications
    3. Requirements to Determine Whether Specifications Are Met
    4. Specific Requirements Regarding Specifications for Dietary Ingredients and Other Components
    5. Representative and Reserve Samples
  10. Subpart F – Production and Process Control: Requirements For Quality Control
  11. Subpart G – Production and Process Control: Requirements For Components, Packaging, And Labels And For Product That Is Received For Packaging Or Labeling As A Dietary Supplement
    1. Requirements for Components
    2. Requirements for Packaging and Labels
    3. Requirements for Received Product
    4. Requirements for Rejected Components, Packaging, Labels and Received Product
  12. Subpart H – Production and Process Control: Requirements for a Master Manufacturing Record
  13. Subpart I – Production and Process Control: Requirements for a Batch Production Record
  14. Subpart J – Production and Process Control: Requirements for Laboratory Operations
  15. Subpart K – Production and Process Control: Requirements for Manufacturing Operations
  16. Subpart L – Production and Process Control: Requirements for Packaging and Labeling Operations
  17. Subpart M – Holding and Distributing
  18. Subpart N – Returned Dietary Supplements
  19. Subpart O – Product Complaints
  20. Subpart P –Records and Recordkeeping
  21. References

Contains Nonbinding Recommendations

Guidance for Industry1

Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Small Entity Compliance Guide

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

I. Introduction

On June 25, 2007, FDA published in the Federal Register a final rule that established a regulation (21 CFR part 111) entitled Current Good Manufacturing Practice (CGMP) In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752). The Dietary Supplement (DS) CGMP rule in 21 CFR part 111 (“the DS CGMP rule”) requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
In the same issue of the Federal Register (72 FR 34959), FDA also issued an interim final rule (the identity testing interim final rule) setting forth a procedure for requesting an exemption from a requirement of the DS CGMP rule for the manufacturer to conduct at least one appropriate test or examination to verify the identity of any dietary ingredient that is a component of a dietary supplement. The provisions of the identity testing interim final rule have the full force of law, but FDA provided a 90-day comment period on those provisions through September 24, 2007. On September 17, 2007, FDA published a notice in the Federal Register to extend the comment period to October 24, 2007.
The DS CGMP rule and the identity testing interim final rule were effective as of August 24, 2007. The compliance dates are described below.
FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in the DS CGMP rule (21 CFR part 111). The DS CGMP rule is binding and has the full force and effect of law.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Discussion

  1. Compliance Dates for the Dietary Supplement Current Good Manufacturing Practice Rule (DS CGMP Rule) and the Interim Final Rule
    1. What were the compliance dates for the DS CGMP rule? As shown in Table 1, the compliance dates were based on how many full-time equivalent employees (FTEs) you employ.
    Table 1
    Compliance Dates Based on the Size of Your Organization
    If you employ … The DS CGMP rule required you to comply by …
    500 or more FTEs June 25, 2008
    At least 20 but fewer than 500 FTEs June 25, 2009
    Fewer than 20 FTEs June 25, 2010
  2. Organization of the DS CGMP Rule
    1. How is the DS CGMP rule organized? The DS CGMP rule is organized as a series of “subparts,” which each cover a different aspect of current good manufacturing practice. We list these subparts in Table 2.
    Table 2
    Subparts of the DS CGMP Rule
    Subpart Subject of Subpart
    A General Provisions (including coverage and definitions)
    B Personnel
    C Physical Plant and Grounds
    D Equipment and Utensils
    E Requirements to Establish a Production and Process Control System
    F Production and Process Control System: Requirements for Quality Control
    G Production and Process Control System: Requirements for Components, Packaging, Labels and for Product that You Receive for Packaging or Labeling as a Dietary Supplement
    H Production and Process Control System: Requirements for the Master Manufacturing Record
    I Production and Process Control System: Requirements for the Batch Production Record
    J Production and Process Control System: Requirements for Laboratory Operations
    K Production and Process Control System: Requirements for Manufacturing Operations
    L Production and Process Control System: Requirements for Packaging and Labeling Operations
    M Holding and Distributing
    N Returned Dietary Supplements
    O Product Complaints
    P Records and Recordkeeping

III. Subpart A – General Provisions

  1. Coverage of the DS CGMP Rule
    1. Who is subject to the DS CGMP rule? You are subject to the DS CGMP rule if you manufacture, package, label, or hold a dietary supplement.
      (21 CFR 111.1(a))
      In our answers to questions in sections III.A, III.B, III.C and XIX of this document, we address some specific examples of firms who do, or do not, fall within the coverage of the DS CGMP rule.
    2. Am I subject to the DS CGMP rule if I am a foreign firm? Yes. The DS CGMP rule applies to you if you manufacture, package, label, or hold a dietary supplement imported or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
      (21 CFR 111.1(a)(2))
    3. Am I subject to the DS CGMP rule if my product is sold only within my state? You may be subject to the DS CGMP rule for products sold only within your state. FDA may consider its jurisdiction over such products under the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, or both, depending on the circumstances of the situation.
      (72 FR 34752 at 34785)
    4. Am I subject to the holding requirements established in the DS CGMP rule if I am a retailer who is holding dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers? No. Importantly, a retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.
      (21 CFR 111.1(b); 72 FR 34792)
    5. Am I subject to the holding requirements established in the DS CGMP rule if I am a retailer who operates a warehouse or storage facility? Yes. The “retail exemption” does not apply to you, because a retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers (21 CFR 111.1(b); 72 FR 34752 at 34792).
    6. Do the requirements of the DS CGMP rule apply to all types of dietary supplements (e.g., for botanical dietary supplements and for vitamin/mineral dietary supplements)?"



     

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