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Why do we mention the FDA Rules for Labeling as the notion of whether something is a Cosmetic or a Drug? We feel it is important for folks to know that the information presented on our website about what a product may do is derived from research in multiple aromatherapy texts and is often reviewed with folks well respected in the field of aromatherapy. In addition information presented on the benefits of our vibrational healing spritzs comes from representative findings that result from aura photography.
Our products are not assessed by the FDA. In the interest of being fair with our customers, we feel it is very important for you to know that. When we say that something eases inflammation, it is based on knowledge in aromatherapy texts and random field studies, not based on the FDA approval of this label after testing that this product reduces inflammation.
If the FDA felt that our product was in the drug category and we did not provide you with the disclaimer that a product is not evaluated by the FDA, Hummingbird Therapeutics would be required to inform you of the following information announced 9/3/06 by the FDA:
Drug Facts- title
Active ingredient(s) - including amount in each dosage unit
Purpose - pharmacologic class
Use(s) - indications
Warnings
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Do not use- absolute contraindications, when the product should not be used under any circumstances
Ask a doctor before use if you have - warnings for persons with certain preexisting conditions and for persons experiencing certain symptoms
Ask a doctor or pharmacist before use if you are - drug/drug and drug/food interactions
When using this product - side effects that could occur and substances or activities to avoid
Stop use and ask a doctor if - signs of toxicity and other serious reactions that would require consumers to stop using the product immediately
Pregnancy/breast-feeding warning
Keep out of reach of children/Accidental overdose warnings
Direction- dosage and when, how, or how often to take
Other information
Inactive ingredients
Questions? (Optional) - followed by telephone number
The final rule also requires certain graphical features, including:
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Minimum type size
Title = a type size larger than the largest type size
Headings = at least 8 point or 2 points larger than text
Text and subheadings = at least 6 point
- A clear, easy-to-read type style, such asHelvetica or Universe, with no more than 39 characters per inch.
- Left justified text
- Leading- at least 0.5 point (minimum space between lines)
- Kerning- letters cannot touch
- Clearly marked sections with hairlines between sections
- Bold line surrounding Drug Facts information
- Upper and lower case letters only- no all caps
- Bullets- solid square or circle, 5 point type
- Directions table- if three or more categories
- Other graphical highlights- contrast, white space, etc.
There are also special provisions which allow modifications when the information does not fit on small or unusually shaped packages:
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These exemptions may be used if 60% of available label space is insufficient to bear required labeling information.
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If more than one bulleted statement is on a line, the second bullet may start on one line and continue to the next line. Also bulleted statements need not be vertically aligned.
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Surrounding box may be omitted if information is offset using color contrast.
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Less than 0.5 point leading may be used.
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Headings may be presented using a 7-point minimum type size.
3. When will consumers start to see the new labels?
For many products, the new labels will appear on products within the next 2 years. OTC drug products that have sales of less than $25,000 per year will receive a special one-year extension. Certain OTC drug products are not required to use the new format for 6 years, although manufacturers of these products are encouraged provide the new labeling sooner.
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We hope this helps you understand why we state on all our products that our products have not been evaluated by the FDA and that our products are not intended to treat, diagnosis, cure or prevent disease. And that you should consult a doctor or health care professional if you have concerns about your health, or concerns about the use of our products.
Thank you.
Our labeling reflects our committment to you.
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