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FAQ's

What is the active ingredient in Fresh Protect?
Fresh Protect does not use drying alcohol. Fresh Protect employs the use of Benzalkonium Chloride – an antiseptic. The active ingredient is not naturally derived. However, it is found in of grapefruit seed extract.

Does Fresh Protect Meet CDC Guidelines for Health-Care Settings?
YES...Fresh Protect meets and exceeds CDC guidelines for hand hygiene hospital protocol.

What germs does Fresh Protect kill?
Fresh Protect kills 99.99% of household, community and hospital germs.  Germs that are carried person-to-person, and germs that people pick up from inanimate objects and hard surfaces and animals.  Germs than can make people very ill. 

How natural is Fresh Protect?
Fresh Protect spray and foam are All Natural and the lotion / product is 96.9% Natural.  Fresh Protect bases it's Natural claims on the NPCIP standards. www.npcip.org  (Natural Personal Care Ingredients Panel)

Is Fresh Protect really made without alcohol?
Fresh Protect does not contain the alcohols that alcohol-based sanitizers use. 
Fresh Protect is not-flammable nor does it cause drunkeness.

Fresh Protect does not claim to be made without any trace amounts of fatty alcohols.  Technically, many common chemicals are actually a form of alcohol... Such as glycerin/glycerol (humectant), caprylyl glycol (preservative), phenoxyethanol (preservative) , cetyl / ceteryl / steryl alcohol (emulsifiers).

Does Fresh Protect moisturize?
Fresh Protect Sanitizers moisturize the hands and skin with every use.  Fresh Protect incorporates the natural botanicals Vitamin E, Aloe Vera, Oat Extract, Green Tea Extract and Glycerin to effectively moisturize the skin.

Does Fresh Protect contain parabens?
Fresh Protect has no known or added parabens. 

How often can I use Fresh Protect Sanitizer?
Fresh Protect can and should be used after and before each patient, after each use of a bathroom,
and after handling objects. It does not replace hand washing.

How long does a container last?
How many applications are in an ounce of Fresh Protect Sanitizer?
Expected yield per ounce of Fresh Protect Sanitizer is here listed:
          Lotion/Product: Over 50 pumps per ounce.
          Spray: Over 200 pumps per ounce.
          Foam: Over 70 pumps per ounce.
     This in not necessarily indicative of cost-effectiveness...
     A person will tend to use 1-2 pumps of lotion or 4-6 pumps of spray or 1-2  pumps of foam to be adequately protected.

Can I use Fresh Protect with disposable or examination gloves?
Fresh Protect is compatible with disposable exam gloves. 

Can I use Fresh Protect to replace hand washing?
Fresh Protect can compliment regular hand washing, but should not replace it.

The Center for Disease Control (CDC) suggests that good hand hygiene (i.e., hand washing) should be practiced frequently, several times a day, especially after using the bathroom.

What is the proper hand washing technique?
Washing your hands periodically throughout the day can prevent you from getting sick and spreading germs to others. However, proper hand washing takes some know-how. Running your hands under the facet for a few seconds does not constitute proper hand washing technique.

Begin by wetting your hands with clean warm water and applying a liberal amount of soap. Next, wash your hands with the soap and water for at least 20 seconds. When you finish washing, rinse well. Dry your hands on a paper cloth or air dryer (if one is available). Always use your paper cloth to turn off water after washing your hands to reduce the risk of surface contaminants.
 

Is Fresh Protect tested on animals?
No. Fresh Protect believes in humane practices and does not test on animals.

Is Fresh Protect effective against gram-negative bacteria?
Yes, Fresh Protect effectively kills gram-negative bacteria at a kill rate of 99.99%>

 

Why can't 'Fresh Protect Sanitizers' disclose to the public it's full potential?
Current FDA regulations in the USA do not allow claims about any type of anti-viral or anti-fungal activity for hand sanitizers.  In other words, if a hand sanitizer was proven by independent lab testing to effectively kill molds, fungus or viruses, (H1N1, Swine Flu, Norovirus, common flu, Herpes Simplex, MRSA, VRE, C.diff. and many others), in one minute or less, it could not be sold in the USA with those claims.  It could only claim to kill bacteria / germs.
It cannot claim any persistence. In other words, if a hand sanitizer was proven by independent lab testing to persistently kill germs with 100% effectiveness for over 4 hours, it could not be sold in the USA with those claims. It could only claim to kill 99.99% of bacteria / germs.  Therefore, we emphatically state that Fresh Protect Sanitizers, sold for use in the USA, do NOT exhibit any of these stated activities. No one should assume or state that Fresh Protect Sanitizers have any biocidal activity other than the antibacterial claims allowed by law.

The FDA published a Warning Letter about Fresh Protect products... What is that all about?
The FDA published a warning letter to Omega Tech Labs, LLC on October 21, 2008 (http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048091.htm). The FDA really doesn't give a fair chance to respond. Omega now addresses, in part,  the FDA warning letter to Omega.

The purpose of the FDA is to safeguard public health and provide to consumers food... and drugs that are safe, unadulterated and honestly presented. (edited from the FDA web sites)

Omega Tech Labs, LLC appreciates the opportunity to respond to the issues raised in FDA's October 21, 2008 Warning Letter, and to clarify the nature of our Boise, Idaho OTC manufacturing operations.

Omega is committed to complying with applicable laws and regulations, and to ensuring high quality products for its intended end-users. This letter responds to FDA's concerns and, where appropriate, identifies areas where we intend to make voluntary changes to address these concerns.

     FDA states in the Warning Letter:
     The Stop, Motion, and Promise Products are Unapproved New Drugs and Misbranded
The FDA facility inspector reviewed each of these products and labeling during the inspection.  The inspector sent copies of the labeling to the FDA regional director.  We received a complete and total acceptance of wording and packaging from FDA with the intent of Omega to clarify some specific wording on the packaging before the next printing of labels.  It was a total shock and surprise on their 'turn-around' regarding the Stop, Motion, and Promise Products.  How can they be unapproved new drugs and misbranded when they themselves approved them.  Omega has removed these products entirely from the USA market.

     FDA states in the Warning Letter:
     (Fresh Protect)  ...   The New Drug and Misbranding Violations

     FDA states in the Warning Letter: As presently labeled and promoted, these products violate the new drug and misbranding provisions under Sections 505 and 502, respectively, of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 355 and 352), as described below. In addition, the inspection documented significant deviations from the Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals (Title 21, Code of Federal Regulations (C.F.R.), Parts 210 and 211), as described below. Such deviations cause the Fresh Protect Products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Act. 21 U.S.C. § 351 (a)(2)(B).

Omega does not intentionally introduce unapproved new drugs into interstate commerce, nor  does it manufacture drugs, (Omega manufactures OTC) and does not need approved NDAs before dispensing its OTC products. Our  products are not misbranded. We are lawfully engaged in the practice of manufacturing OTC products in compliance with FDA's  laws and rules. The FDA CFRs are very difficult to read and interpret.  We have consulted with several nationally known firms that deal with interpretation of FDA CFRs, none of them can agree on interpretation even simple CFR rules.  When addressing FDA offices in Seattle and Washington DC regarding specific interpretations, neither had the same answer for the same questions.  The FDA field inspectors similarly, had conflicting answers. We have complied with all labeling requests.

The Warning Letter also refers to OTC drug information sheets, labeling and web site information for Fresh Protect products, characterizing them as all-inclusive labeling, and takes issue with the contents of the information sheets, labeling and web site information. As a legal matter, we believe that FDA lacks the authority to prescribe the wording of information sheets, labeling and web site information for OTC products as long as it is factual and honestly presented and does not conflict with FDA TFMs that govern these type of products. The requirement to exclude from the end-user adequate directions and capabilities of these products  do not apply to OTC drugs for the same reason reasons that the NDA provisions are inapplicable. Nonetheless, Omega understands FDA's concerns and has voluntary reviewed the drug information sheets, labeling and web site information referred to in the Warning Letter and made any and all appropriate revisions.

We feel it is not it the publics best interests to not be fully informed of the full capabilities of Fresh Protect OTC products. With the purpose of the FDA  to safeguard public health and provide ... drugs that are safe, unadulterated and honestly presented, we feel the public is not being fully informed.  The claims of just what Fresh Protect sanitizers can do is being suppressed by the FDA.  Here is a direct quote from the Warning Letter:

(start quote)
The Fresh Protect Products are "drugs," as de fined by Section 201(g)(1) of the Act (21 U.S.C. § 3 21(g)(1)), because they are intended to cure, mitigate, treat, or prevent disease, and to affect the body's structures and functions. As described above, these products are intended to prevent diseases caused by infection with Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE), Clostridium difficille (C.Diff.), Norovirus, Herpes, Influenza, Staph, Strep, and E. Coli, and P. Aeruginosa viruses. They also are intended to cure, mitigate, or treat disease and/or affect the body's structure or functions by rejuvenating skin cells and reducing skin lesions.

Further, these products are "new drugs," as defined by Section 201(p) of the Act (21 U.S.C. § 321(p)) because we are not aware of sufficient evidence to show that they are generally recognized as safe and effective (GRASE) by scientific experts in: (1) preventing the diseases caused by infection with MRSA, VRE, C.Diff., Norovirus, Herpes, and Influenza viruses, and the other microorganisms listed in the product labeling; or (2) cell rejuvenation, reducing skin lesions, and remaining on the skin and being effective for up to four hours.

...
(end quote)

Omega has since removed all of the claims as mentioned above.  Interestingly, however, Omega did the testing for the various claims listed above and, to the publics detriment, Fresh Protect products cannot make the claims because of the FDA interpretation of the CFR.

     FDA states in the Warning Letter:
     The Fresh Protect Products Are Adulterated Due to CGMP Violations at Your Manufacturing Facility

Fresh Protect Products are not  and never were 'adulterated'.
Although, we are guilty of some of the CGMP Violations, each alleged violation really needs to taken into context.  The FDA took most out of context and built a mountain out of a mole-hill.  How sad, the very organization that is supposed to help the public be safe and guide the private manufacturers to be better at what they do, chooses to level nit-picky allegations at us.

We will now list a few of the allegations:

A. Failure to perform for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, as required by 21 C.F.R. § 211.165(a).

Omega's Response:  It could have been better at the time of the inspection, but we were able to determine conformance to final specifications. We now (2010) do it to the satisfaction of the FDA.

C. Failure to have written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity that they purport or are represented to possess, as required by 21 C.F.R. § 211.100(a).

Omega's Response:  It could have been better at the time of the inspection, but we were able to determine conformance to final specifications. We now (2010) do it to the satisfaction of the FDA.

D. Failure to have master production and control records that include complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed to assure drug product uniformity from batch to batch, as required by 21 C.F.R. § 211.186(b)(9).

Omega's Response:  It could have been better at the time of the inspection, but we were able to determine conformance to final specifications. We now (2010) do it to the satisfaction of the FDA.


F. Failure to thoroughly investigate unexplained discrepancies or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, as required by 21 C.F.R. § 211.192.

Omega's Response:  It could have been better at the time of the inspection, but we were able to determine conformance to final specifications. We now (2010) do it to the satisfaction of the FDA.
 

The FDA cannot even understand, let alone interpret their own CFRs, so when Omega applied it's understanding of the CFRs to the development and labeling of it's products, we did our level best.  So rather than work with us, the FDA, very aggressively, issued the warning letter.  We admit and, frankly, are thankful to the FDA for the help they have provided.  We had errors in wording and misunderstanding of some CFRs and we are now a much better company today regarding implementation of CGMPs.  However, to get to this understanding did not warrant an FDA Warning Letter.