cGMP, Labeling and Legal requirements Flashcards
(97 cards)
1
Q
What is cGMP?
A
cGMPs describe the conditions and practices necessary for processing, manufacturing, packaging, and storing dietary supplements to ensure their safety. GMPs are meant to ensure authentication, purity, quality, consistency, documentation, traceability, and accountability during and after the manufacturing process in order to prevent adulteration and contamination of herbal products.
2
Q
what does the c in cGMP stand for?
A
The “c” in cGMPs stands for “current.” You need to make sure that you stay current and up-to-date with changes and updates to the Code of Federal Regulations (CFR) regarding current regulations, ingredients, and sanitation practices.
3
Q
Where is the cGMP described?
A
The cGMPs are described in the Code of Federal Regulations (CFR) which is the master book of administrative laws.
4
Q
How many titles are there under the CFR?
A
currently there are 50 as described in the CFR
5
Q
Which titles and parts are of specific importance for herbalist?
A
Title 21 CFR
Title 21 CFR, which has 1500 parts, deals specifically with commodities that are regulated by the FDA, including food, dietary supplements, and cosmetics.
21 CFR 111
Part 111 is the specific part within Title 21 that deals with cGMPs for dietary supplements (also referred to as 21 CFR 111).
21 CFR 110
Part 110 is the specific part within Title 21 that deals with cGMPs for food products (referred to as 21 CFR 110). .
6
Q
What authority is given to the FDA under 21 CFR 111?
A
FDA has the authority to conduct inspections and check manufacturing facilities and processes under 21 CFR 111
7
Q
What does 21 CFR 111 deal with?
A
Dietry supplements
8
Q
What does 21 CFR 110 deal with?
A
Food products
9
Q
How does the FDA define ‘Food’?
A
Food is defined by the FDA includes raw, cooked, processed edible substance, ice, beverage, or ingredient used to sell for ingestion.
10
Q
How does the FDA define “Supplement”?
A
Dietary Supplement is defined by the FDA is a product other than tobacco intended to supplement the diet that contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or any other botanical substance, constituents, extracts or combination of any of the ingredients above. While food is considered part of a diet, a dietary supplement is something that is added to the diet as a supplementary form of support to aid in wellness. It can be in the form of a pill, bar, powder, and liquid.
11
Q
how does the FDA define ‘Drug’?
A
Drug is defined by the FDA as a product that is intended to cure, mitigate, treat, or prevent disease. It is a product that is developed to impact the structure or function of the body of a human or animal and address a health need.
12
Q
What statement always needs to be displayed on herbalist marketing material or website?
A
For educational purposes only. This information has not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure, or prevent any disease.
13
Q
What is the purpose of the The Dietary Supplement Health and Education Act (DSHEA),of 1994?
A
The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994 under the Clinton administration, was created to ensure that there is a continued access to a wide variety of dietary supplements and provide information on those dietary supplements.
14
Q
Do Supplements require pre-approval form the FDA prior to sale?
A
No
15
Q
How does the law distinguish between whether a product is a cosmetic or a drug?
A
Whether a product is a cosmetic or a drug under the law is determined by a product’s intended use.
16
Q
How does the FDA define a ‘cosmetic’?
A
articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance
17
Q
What is meant by ‘Adverse Effects’?
A
Adverse event is any untoward medical occurrence or health event associated with the use of a dietary supplement.
18
Q
What is the business’ responsibilliy in the event of the occurance of an adverse effect, such as illness or injury?
A
Any adverse complaints MUST be reported to the FDA.
19
Q
Why is it nescesary to have a tracebillity system in place?
A
In the event of a reported ‘adverse effect’, having a traceability system in place will allow you to identify all of the components that went into a batch and track it so all lots affected can be pulled from the shelf.
20
Q
What is meant by the term ‘Batch’?
A
Batch is the specific quantity of a dietary supplement that is uniform and intended to meet certain specifications for identity, purity, strength, and composition. A batch is produced at a specific time period according to a single manufacturing record (MMR). Each batch must have a batch number
21
Q
Why is having a Batch number on your lables important?
A
It is important that manufacturers have a system of traceability for each batch. These numbers should be on all of your labels so if there is an issue you can use that batch/lot# to trace all ingredients back to their original sources.
22
Q
What is meant by the term ‘component’?
A
Component is any substance intended for use in the manufacturing of a dietary supplement, including those that may not appear in the finished batch. A component may not end up in the packaged product, but it was part of one of the manufacturing steps. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients. Please note that “other ingredients” are not specified.
23
Q
What is meant by the term ‘Composition ‘?
A
Composition is the formula recipe or the specific amount of each ingredient.
24
Q
What is meant by the term ‘Contact surface’?
A
Contact Surface is any surface that contacts a component of a dietary supplement. This could include ingredients, utensils, bowls, tables, or conveyer belts. Basically, any equipment, packaging, and workspace that is used and touched in and during the manufacturing process is a contact surface. You’ll always want to make sure you’re not introducing a health hazard, whether chemical or environmental, from a contact surface into a product, so all contact surfaces should be properly cleaned and sanitized. You will also want to make sure that the chemicals you use for sanitization do not introduce a potential hazard. Other potential physical hazards include shards of glass, metals, stickers, dirt, or microbes.
25
What is meant by the term 'Identity'?
Identity is the fundamental confirmation that the dietary ingredient is exactly what it’s supposed to be. You can establish identity by chemical analysis, genetic analysis, organoleptic analysis, sensory identity, and other physical analysis.
26
What is meant by the term 'Ingredient'?
Ingredients are any substances used in the manufacturing of a dietary supplement that will be a component in the finished batch of the dietary supplement.
27
What is meant by 'In process material'?
In Process Material is any material that is fabricated, compounded, blended, sifted, extracted, ground, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacturing of a dietary supplement.
28
What is meant by 'lot'?
Lot means a batch or a specific portion of a batch.
29
What is meant by 'Micro-organism'?
Microorganisms are organisms that you cannot see with the naked eye such as yeast, molds, bacteria, viruses, and other organisms that pose a potential risk to the health of the public.
30
What is meant by 'Pests'?
Pests include such things as insects or animals that could potentially make a substance unsafe. You will need to have a plan to prevent and eliminate these pests from your facility. This includes but is not exclusive to mice, rats, flies, larvae, mites, and domestic pets.
31
What is meant by 'Plant'?
Physical Plant is all or any part of the building that is being used for making, packing, labeling, or holding/storing dietary supplements.
32
What is meant by 'Product Complaint'?
Product Complaint is any communication (be it oral, written, or electronic) expressing concern for any reason regarding the safety of a dietary supplement. This could include but not be exclusive to complaints of foul odor, off taste, illness or injury caused by the use of the dietary supplement, color variation, under-filled or over-filled containers, or product strength.
33
What is meant by 'Purity'?
Purity means that the product is free of environmental toxins and microorganisms and has not been adulterated with other substances.
34
What is meant by 'Quality'?
Quality means that the dietary supplement consistently meets the established specifications for the identity, purity, strength, and composition, and limits contaminants. It also means that your products were kept under conditions that would avoid adulteration.
35
What is meant by 'Quality Controll'?
Quality Control is a plan and systematic operation or procedure for ensuring the quality of a dietary supplement. This requires checks and balances implemented throughout the entire process, not just at the end of a process.
36
Wat is meant by 'Quality Control Personnell'?
Quality Control Personnel are any persons or group outside of your organization whom you designate to ensure and enforce quality control program procedures.
37
What is meant by 'Representitive Sample'?
Representative Sample is a sample of an adequate number of units drawn from the greater batch. A representative sample would include random samples from the top, middle, and bottom of a batch as opposed to just the top or bottom.
38
What is meant by 'Reserve Sample'?
Reserve Sample is a representative sample of a product that is held for a designated period of time. For every batch of product that you create, you are required to have a reserve sample of that product. I have been told that your sample needs to be stored in the same size bottle that the product is sold in, e.g., if you are selling a product in an 8 ounce bottle, the reserve sample also needs to be in an 8 ounce bottle. These samples are important in the case of product complaints. If someone were to complain about the quality of a batch or lot or had an adverse event after consuming the product, then you would use the reserve sample for testing purposes.
39
What is meant by 'Reprocessing'?
Reprocessing means removing clean, uncontaminated components or dietary supplements from manufacturing and making them suitable for use in the manufacture of a dietary supplement.
40
What is meant by 'Sanitization'?
Sanitization means to adequately clean and sanitize utensils, containers, and contact surfaces using a process that is effective in killing microorganisms that have potential to cause public health harm.
41
What is meant by 'Strenght' or 'Potency'?
Strength, which is sometimes called potency, is defined as the concentration of active ingredients in a dietary supplement. The ratio of botanical material to solvent/menstruum for a tincture could be used to determine the concentration or strength of the final product to ensure that the tincture is not too strong or too weak.
42
What is meant by 'Theoretical yield'?
Theoretical yield is the amount of a product you ideally believe should be produced based on the adding up of all the components that go into making your batch. The actual yield tends to differ from the theoretical yield.
43
what is meant by 'Water Activity'?
Water Activity (Aw) is the amount of free moisture in a product. Because moisture will attract microorganisms, which pose a potential health risk, the lower the Aw in your products, the better. If the Aw in your products is high, then they pose a potential risk and you will need to reformulate them. Semi-solid products may have a high water content, but the water availability is low. Aw is calculated by dividing the water vapor pressure of the substance by the vapor pressure of pure water at the same temperature, so requires specialized equipment or laboratory testing to measure.
44
What is meant by 'actual yield'?
Actual Yield is the quantity that is actually produced at any particular step in your manufacturing. It is the actual amount of a product yielded in the manufacturing process— and rarely tends to be what we intended or thought the yield would be.
45
what are the major documents that are required by the cGMP?
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(SOP) standard opperating procedure document
(COC) Code of Conduct for personnel
(MMR) Mater Manufacturing Record
(BCR) Batch controll record
Logs
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46
What documentation is required in relation to personnel?
21 CFR 111 Subpart B requires documentation that shows that people involved in the manufacturing process are following the correct hygienic policies and are not coming to work sick (in order to prevent microbial contamination). It also requires documentation that supports that the personnel are qualified and trained for the positions that they hold. You will also need to keep documentation and rosters of any training you provide. Additional documents that you will want to have include:
Dress Code: this includes the use of hairnets, hats, or bandanas. Hair nets are more effective than bandanas and hats. You can set your own dress code as long as you keep in mind that the goal is to avoid cross-contamination. Some places require lab coats or that arms are covered.
Sick Policy: People involved in manufacturing may not work while they are ill. If they arrive to work sick, or become sick on the job, they must be sent home.
Safety precautions
Training procedures
Training records: include material covered and attendance roster.
Hygiene policy
Job descriptions
Responsibilities: what is expected from your employees.
Employee credentials, previous classes, training, etc.
Regular staff meetings keeping the communication avenues amongst employees open and clear.
47
What documentation is required in regards to plant or premise maintanance?
21 CFR 111 Subpart C requires written procedures for cleaning of and pest control in the physical plant. The physical plant includes all of the facility used for manufacturing, packaging, labeling, and holding of dietary supplements. You will need a SOP that lists step-by step-procedures detailing how the facility and grounds are maintained so that you can ensure that things from the outside grounds are not coming inside. The FDA does not define this for you, so it is up to you to create a system and SOP specific to your business and your premise based on the cGMP requirements that states how your company complies. The following documentation is required:
Trash disposal SOP: Document how trash is managed and disposed.
Pest control SOP: Document how the grounds around the facility are maintained, grass cutting/leaf removal, proper outside drainage, and space between outside plants and the outer wall of the facility. You need to document the pest control measures and how to protect against contamination and record implementation of these practices in a weekly observation log and pest control maintenance log.
Cleaning and Sanitation SOP: Establish standard practices for cleaning and sanitation practices at your facility to prevent contamination. Requirements are discussed in 21 CFR 111 Subpart K. If you are using a third party such as a co-packer, it is important that they also follow SOPs/standards you have set for your company. Sanitation can also include cleaning and sterilization of equipment and supplies like the bottles your products are packaged in. The use of safe sanitation agents is important, but as these could be also potential hazards, you will need to store any toxic material where it cannot contaminate products. These items must also be properly labeled, as should all cleaning and sanitation agents, even something seemingly harmless like soap. Some things that we generally think of as harmless may not be considered that way by the FDA. For example, printers and ink cartridges are considered a hazardous material.
Cleaning and Sanitation Logs: Supporting logs used to document that tasks prescribed in the Cleaning and Sanitation SOP have been completed. Logs provide paper confirmation that what you say you have done really has been done. Include both who has done the task and time and date when it was done.
Equipment and Utensils SOP: Document how to properly use, maintain, clean, and sanitize equipment and utensils.
Equipment and Utensils Usage Log: Keep track of every time a piece of equipment or utensil is used.
Maintenance SOP: Document maintenance activities, such as the condition and upkeep of equipment, maintaining the temperature of the fridge, or maintaining the temperature of the water in a dishwasher.
Maintenance Log: Document temperatures, and any type of service or maintenance that was performed.
Calibration SOP: Any scale that you may use need to be periodically calibrated in order to verify it is measuring properly. You can purchase National Institute of Standards and Technology (NIST) calibration weights, but they tend to be very expensive. Cooperative extension offices will often schedule a calibration day,
so check with your local extension office about this. You could also pay someone to calibrate your scale.
The premises will also need to meet any state regulations and requirements including water supply and water quality tests. Hot water must reach a certain temperature and maintain that temperature for a certain amount of time. States may require a three bay sink for manufacturing and a separate hand washing sink. States may have still other requirements: items may need to be stored at least 6 inches off of the floor, all doors must be able to close, all surfaces (even non-contact surfaces) need to be washable and washed regularly, and a bathroom with a hand washing sink may be required to be in a certain proximity to the toilet.
48
What two documents are required for Production and Process controll?
MMR -Master Manufature Record
| BPR - Batch Production Record
49
What is a MMR and why is it important?
21 CFR 111 Subpart H describes requirements for the Master Manufacturing Record (MMR), a master list of specifications for the points, steps, or stages in the manufacturing process of a particular product. Think of this as your recipe for a product. Use of an MMR ensures consistency of product, accurate use of component ingredients, and proper order of the manufacturing process. Some of the required information that needs to be included in your MMR includes (see 21 CFR 111.210 for full list):
Name of the dietary supplement
Strength and concentration
Weight or measurement of your batch or size
Ingredients
Statement of theoretical expected yields
Description of packaging and labeling
Specifications
Sample procedures
Actions necessary to perform and verify points of control in the manufacturing process to ensure the quality and correct packaging and labeling of the dietary supplement
You will need to create an MMR for each product you make, so if you make thirty different tinctures you need one for every tincture. You also need to have separate MMRs for various batch sizes of the same product – so if you make both 1 gallon and 5 gallon batches of elderberry elixir, you need an MMR for each of the batches.
50
What is a Batch Production Record, or BPR?
21 CFR 111 Subpart I describes requirements for the batch production record (BPR). While similar to the MMR, the BPR is more specific to each of the batches you are making, and includes when the batch was produced and which raw materials/vendor lots were used in production of the batch. The MMR is the set standard, or master recipe, while the batch process record is the documentation that you keep for each batch of that recipe that you produce. For example, I have an MMR for my elderberry elixir and each time I make that elixir I also complete a batch process sheet.
The batch production records are for quality control purposes: keeping track of what goes where and ensuring the traceability of every step of the process. Some of the required information that needs to be included in the BPR includes (21 CFR 111.260 describes the full list):
Batch Code
Equipment used in production. You will want to keep track of the date and times that this equipment was cleaned or sanitized and or maintained; you could also cross reference to one of your logs for this information.
Packaging and ingredient lot numbers. When I am writing up my batch record I list all of the ingredients, where the herbs came from (like Zack Woods Farm, Mountain Rose Herbs, or my farm) and then I write down the lot number of that batch of dried herbs in my batch records. This is my process, but it is worth investigation how other manufacturers do it to be sure you are capturing the needed information.
Identity and weight/volume measurements for each ingredient
Your theoretical yield for that batch and the actual yield once the batch is finished.
Monitoring and test results (e.g., shelf stability test and full microbial analysis test)
Documentation that the product meets all the specifications set in your SOPs
Quality of packaging and labeling used
Initials of who performed what task and when
Again, you will need to write up a batch production sheet for every single batch you make. When you are making your batch and or bottling your products, be sure to keep a representative/reserve sample of that particular batch and or various lots.
51
How can we ensure consitency within our documents and record keeping?
establish an outline of the structural format (e.g., margins, headers, and footers) and the text format (e.g., font size, bold, underline, etc.) you will use for all of your documents.
Each document should have a header at the top with the effective date, title, and document I.D. If this is a version of a document created after the original, include the version number. You will also need the following:
Statement of Purpose: Also known as the executive summary, this explains why the document was created and how it’s meant to be used, and or how it fits into the larger picture and its goal or purpose.
Scope: This relates to the specific and functional areas affected. For example, it might say, “the scope of this document relates to Grounds and Pest Control personnel.”
Responsibility: The name and/or job title of the person responsible for the duties or information included in the document.
Definitions: You may want to have definitions explaining any language used that may be technical and specific to your company and the scope of the document. If slang or words that have multiple meanings are used, you will want to clarify how they are being used in that document.
Body: This is the primary content of your documents, which should be understandable and have logical flow.
Related Documents: Reference and list any documents that are related or are used as reference.
History: If you need to change the layout of the document, you will want the name of the person who originally created the document, when it was first issued, the name of the person who changed the document, the date the new document was approved for use, and the reason for making the changes to begin with.
You will want to watch out for both document overlap and not providing enough relevant information. Include the proper links to related documents.
Create a master list of all of your documents and their identification numbers.
You will want to record facts, not your opinions, so you don’t want use words like “I think.” Use short sentences and simple language so anyone who reads your documents will be able to understand them no matter their background. You will want to date and initial all documents. If you have employees, you should have a master signature sheet on which your employees record their signature, initials, and the date so you have a record of their handwriting and signature that you can refer back to if initials seem off.
If any mistakes are made on the records or documents, use a single line through the mistake instead of scribbling it out or using white out. After striking out the mistake, correct it and then initial and date it.
Make sure that your documents are of a standard so if photocopied, they are easy for someone else to read and understand. You may want to use blue ink so that you’re able to tell your original copies from black and white photocopies.
52
What should you do before creating a new product?
Establish the documentation
53
What is a DCR?
A document controll system
54
How long do you need to keep records for?
You are required to keep records on your dietary supplements for one year past the shelf life if you use dates on your finished labeled product or two years after it was last distributed.
55
Why should you have a POA for FDA compliance?
You also should have a plan of action document, stating the things you are striving to do in order to be FDA compliant. You may have some systems in place but not all that are required to be compliant. Having a document stating what you are currently doing, what you plan to do, and your intended time frame will show any FDA agent that you are aware of the things that you still need to do and that you plan to do them in a specific amount of time.
56
What needs to be defined when creating specifications?
When establishing your specifications you will need to create and define the following:
Specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement;
Specifications for all of the components you use in manufacturing;
Specifications for the products you receive from a supplier;
Specifications for the in-process production;
End-of-process production specifications for the finished batch and the finished labeling and packaging.
57
what is meant by 'Specifications'
Specifications are a measurable standard with or without a tolerance range set to ensure control of any potential risks.
58
What are the different types of Specifications that needs to be established?
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Component specification
Process specification
Labeling and package specificatin
Product specification
Receiving specification
Finished product specificaiton
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59
How should specifications be documented?
When creating documents for specifications, describe what specification is being established and how that specification are being met. You need to keep records documenting every time you meet these established specifications. You will also want to document the scientifically approved test that you used to verify that these specifications have been met so you will need records and SOPs on all of these established specifications.
60
What are the requirements for component specification?
Component specifications detail a substance used in the manufacturing process that may not end up in your final product, but still plays a role and thus may cause potential risk. For this reason, you will want to have a system to evaluate each component, including:
Specifications for identity, purity, strength and composition (defined previously in the terminology section).
Specifications defining what the microbial contamination limits are for a product. Since each product is different you will need to do this for every product you manufacture.
Maintaining representative and reserve samples for up to one year past the shelf life or two years after the last distribution date of that product.
61
What are Process Specifications?
Process specifications refer to any point, step or stage in the master manufacturing record when control is necessary to help ensure that the control and the component are met for the identity, purity, strength, and composition of the dietary supplement.
62
What are labeling and package specifications?
Labeling and packaging specifications are set in regards to the storage, handling, inventory, and dispensing of the final labeled product. They do not refer to the actual contents listed on the label.
63
What are product specifications?
Product specifications refer to the identity, purity, strength, and composition of each dietary supplement batch. This also includes addressing any microbial contamination as well as product complaints.
64
What are Receiving or assurance specifications?
Receiving or assurance specifications are used when you receive materials intended for the final labeled product to verify that the materials have been properly identified and are consistent with a purchase order or Certificate of Analysis so that you can ensure that what you have received is what it says it is. It is a good habit to request Certificates of Analysis from your vendors, as well as organic certifications if you are using certified organic products and plan to certify and label your product as organic.
65
What are Finished Product Specifications?
Finished product specifications are used to ensure that the specified package and label are on the proper product. You may also want to have specifications for holding and storing of the products and for product returns and complaints.
66
Name four different kinds of tests that can be used for Botanical Identification?
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Organoleptic analysis
Macroscopic analysis
Microscopic analysis
Chemical analysis
Other scientifically valid methods
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67
What is Organoleptic identification?
Organoleptic analysis is sometimes referred to in 21 CFR 111 as gross organoleptic analysis. This is a method of identity in which you use your sense of taste, sight, smell, and touch to identify the color, flavor, odor, and/or appearance of plant material. You will need to create documentation for all of this.
Taste: bitter, tangy, sour, sweet, salty, pungent, astringent, etc.
Touch: temperature
Texture: smooth, rough, waxy, gritty, soft, hairy, etc.
Odor: aromatic, sweet, spicy, unpleasant, etc.
Visual: appearance, color, etc.
68
What is Macro-scopic analysis or identification?
Macroscopic analysis involves looking at all aspects of the plant with your naked eye. You look at the overall botanical features, making note of the leaf structure, the flowers, bark, and root, often identifying these plants while they still are in the ground. You could include notes on the ecosystem or environment that they are growing in, photographs of the plant (and the field guide page used to identify it), a botanical description of the plant, name of collector/identifier, date collected, and a GPS location for your records. You could also collect a sample of the plant, press it, and retain it in your records; give it an identification number and record its name, date collected, location collected, and your initials.
Things to look for when using macroscopic analysis are:
Shape
Size
Texture
Surface characteristics
69
What is micro-scopic analysis or identification?
Microscopic analysis involves using tools like a microscope to view parts of the plants that cannot be seen by the naked eye.
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Vessels
Cork formation
Chlorophyll
Trichomes
Stem cell cross sections of plants.
Compare your finding to monographs or other proper sources.
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70
What is chemical analysis or identification?
A variety of methods can be used for plant identification via chemical analysis
Spectroscopy uses tools at the visual scale to see the infrared and ultraviolet spectrum qualities of the plant.
Chromatography (including paper chromatography and high performance thin layer chromatography) utilizes the chemical separation of plant components to identify the chemical makeup of the plant.
Mass Spectrometry measures the molecular weight of molecules to identify a plant.
DNA Testing.
71
What is a Certificate of Analysis?
Is a certificate that verifies the identity of a component, ingredient or product and that it is free from bacteria and pesticides.
72
What is the FDA's definition of a Botanical Product?
Botanical product is finished, labeled product that contains vegetable matter which may include plant materials (fresh materials: bark, wood, leaves, stems, roots, flowers, fruits, seeds, or parts thereof, or processed materials: cleaned, frozen, dried, sliced, etc.), algae, macroscopic fungi or combinations of these (U.S. Department of Health and Human Services, 2004).
73
What products are NOT considered Botanical Products by the FDA?
Basically: GMO's, Synthetics, Pharmaceuticals, and Fermented products.
“botanical products” don’t include genetically modified plants, fermentation products, highly purified substances such as pharmaceutical drugs (even if they were derived from a plant), and synthetic compounds (even if they are chemically identical to a plant compound).
74
What are the five catagories that herbal products can fall into?
Food, Supplement, Drug, Cosmetic, Device.
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When do herbal products fall into the food catagory?
When it is intended use is ingestion for sustenanance, taste, aroma or nutritional value.
And if no assumed or stated health benefit are involved
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When do herbal products fall into the Supplement category?
When the intended use is to affect the structur or function of the body, and it is consumed with for an expected health benefit.
Dietary supplement labels and marketing materials must not include health claims
May include structural/functional claims
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When do herbal products fall into the Cosmetic category?
When the intended use involves application to the body for the purpose of cleaning, beautifying and changin apearance.
And the lable makes no therapeutic claim.
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When do herbal products fall into the Drug category?
When the intended use is for preventing, diagnosing, mitigating, treating, or curing disease.
or the lable makes a health claim
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When do herbal products fall into the Device category?
When the intended use is to affect the structure and function of the body, or to treat, mitigate or cure a disease, without being metabolized by the body.
80
Are dietry suppliments allowed to be labled as food?
According to DSHEA, dietary supplements are not allowed to be represented “as a conventional food or as a sole item of a meal or the diet” and a dietary supplement must be labeled as a dietary supplement (U.S. Congress/Senate, 1994).
81
What are the minimum information that needs to appear on a supplement label?
Product name (identity statement)
Product size (net quantity of contents)
Nutrition information
Ingredients (listed in descending order by weight)
Your business name and contact information
Directions for use
A batch number or date that allows you to track the product and its age (per the cGMPs)
82
Which herbal products can be marketed as a food instead of a supplement?
Teas and unprocessed herbs, but only if they make not structural/functional claim and are presented as Culinary herbs labled only with their common and binomial name.
83
When are herbs considered an "unapproved drug"
When it makes any claim to treat, mitigate, prevent, cure or diagnose a disease
84
What regulations are violated by making unaproved health claims?
if you provide claims to your client, do not use language that can be implied as diagnosing, preventing, treating, or curing disease, as you may also be “violating FDA and Federal Trade Commission (FTC) regulations regarding product claims, since in that context the herbal product will be considered an unapproved drug” (American Herbalists Guild, 2013). (Note that FTC has primary jurisdiction over advertising. Part of the mission of FTC is to protect consumers from “fraudulent and deceptive advertising claims about the health benefits and safety of dietary supplements” (Federal Trade Commission, 2001)).
85
What is the Principle Display Panel?
Principal Display Panel (PDP): The label that customers will see first when they see your product on the shelf. This is usually the front of the package. You can list all necessary label information (including that slated for the IP) on the PDP.
86
What is the minimum information that needs to be dispalyed on the disply panel of a label?
1. Statement of Identity
| 2. Net quantity statement
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What information needs to be included in the Information Panel of a label?
1. Ingredient list : Common name in descending order by weight
2. Business information: Business name, street adress, city/town, state, zip code, Preceded by "Manufactured by", "Packaged by" or "Distrubuted by"
3. Country of Origin
4. Allergy warning statement
5. Lot #
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When does the law require one to list transfat on the label?
regulation requires that, when present at 0.5 g or more, trans fat be listed in the Supplement Facts panel of dietary supplements on a separate line under the listing of saturated fat by January 1, 2006.
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Does the FDA require lable approval for dietry supplements before they can be imported or distributed?
Under our regulations, label approval is not required to import or distribute a dietary supplement.
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How does the FDA define a dietry supplement?
Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain 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 dietary intake; or
A concentrate, metabolite, constituent, extract, or a combination of any ingredient mentioned above.
Further, dietary supplements are products intended for ingestion, are not represented for use as a conventional food or as a sole item of a meal or the diet, and are labeled as dietary supplements. The complete statutory definition is found in section 201(ff) of Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321).
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What label statements are required on the containers and packages of dietary supplements?
Five statements are required: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
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Where do I place the required label statements?
You must place all required label statements either on the front label panel (the principal display panel) or on the information panel (usually the label panel immediately to the right of the principal display panel, as seen by the consumer when facing the product), unless otherwise specified by regulation (i.e., exemptions).
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What label statements must I place on the principal display panel?
You must place the statement of identity and the net quantity of contents statement on the principal display panel. Where packages bear alternate principal display panels, you must place this information on each alternate principal display panel.
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How do I locate the principal display panel?
The principal display panel of the label is the portion of the package that is most likely to be seen by the consumer at the time of display for retail purchase. Many containers are designed with two or more different surfaces that are suitable for use as the principal display panel. These are alternate principal display panels.
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What label statements must I place on the information panel?
You must place the "Supplement Facts" panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor on the information panel if such information does not appear on the principal display panel, except that if space is insufficient, you may use the special provisions on the "Supplement Facts" panel in 21 CFR 101.36(i)(2)(iii) and (i)(5). See questions 46 and 56 in Chapter IV for more details.
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Where is the information panel?
The information panel is located immediately to the right of the principal display panel as the product is displayed to the consumer. If this panel is not usable, due to package design and construction (e.g. folded flaps), the panel immediately contiguous and to the right of this part may be used for the information panel. The information panel may be any adjacent panel when the top of a container is the principal display panel.
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What name and address must I list on the label of my product?
You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
