Thursday, July 1, 2010

FDA & FTC Compliance: Wading Through The Muck!

Keeping In The Loop

It seems like a tireless journey of wading through the continuous changes and updates within the cosmetics and skincare industry, trying to always make sure we remain updated at every level.

New photos, take down of pages, updated or changing information and added features such as our Beauty News, Specials and Events, and our new comments box have been occurring since the first part of this year. But what I want to address most importantly are page take downs and product information. This is getting done as my web team has time and I have the time to get them the latest information. It is a constant state of a "work in progress". Plus as we progress forward, much of the information becomes antiquated as the industry thrives and changes. So in the future, our best updates for all pertinent information will be provided through Beauty News since these will be dated when published and later articles will be representative of the latest information as it becomes available to us. Same with our Skin Care Guide!

Not Blatantly Clear And Most Times Confusing

Since our inception and as an FDA registered company, it has been a confusing undertaking at times to disseminate FDA regulations, since much of what they put out there is simple at best, yet can also be conflicting information. In dealing with the FDA, just when you think you have interpreted their meaning, something sticks out to contradict it. I have spent countless hours in phone conversations with the FDA: Cosmetics and Color division, only to have further confusion instilled when asking for clarifications on product labeling and product description. In most cases you can get a completely different answer on a different day than the last.

In the cosmetic community, many of us look to each other for assistance on clarifying the regulations. This then becomes a practice of the "blind leading the blind". Most of my compatriots are equally confused, and what they may be doing is not necessarily accurate either. The length of being in business has little to do with their compliance. So as information becomes available to me, I do my best to comply. And of course watching the huge names in cosmetics.....bad idea always, since they seem to skirt the regulations at every opportunity for marketing purposes.

A History Of Vague Language

The FDA favors utilizing vague language when it comes to product descriptions since they realize the cosmetics industry works with some forms of puffery to a degree to promote its' products as the best, as long as the company doesn't make a medical claim.

Labeling for the most part is straight forward, but in regard to issues like "may contain" USA reference or +/- (symbol) or "color index" and "INCI" names which are utilized by the European Union, are not necessarily endorsed by the FDA. Though there may be some benefit in the future after educating the public on these identifiers, to date the FDA responds with concern about confusion to the consumer especially in terms of INCI since consumers do not recognize the Latin name and CI (color index) does not translate the approved colors by FDA standards. Of course the scientific or synthetic chemical name is always used as it was originally created whether we as a consumer recognize it or not.

The color name and Herbal Extracts and Essential Oils must have the clear and concise English common named assigned on product labels to avoid confusion or problems with possible reactions to the consumer. They have equal concerns of several other issues as well. Letters petitioning the FDA with proposals from CTFA, now known as the Personal Care Products Council, on asking the FDA to comply with EU standards, are below. This is why you will see the Latin along with the English common name in parentheses on a label to be both EU and FDA compliant since many of us ship overseas.

Responses from the FDA On CTFA Petitions:
Letter On Colorants And INCI Names
Letter On "May Contain"
Labeling Language From FDA

Searching their site at times becomes and exercise in futility, mixed with frustration on my part and ambiguity most often on theirs.

An example of this is made clear in this Lawsuit against the FDA on Vague and Ambiguous Language. Once I discovered this, it gave me great relief that I wasn't simply dim-witted (I was beginning to wonder there for awhile), or trying to deliberately ignore what should be the obvious. Best part, there are others when dealing with the FDA, not getting to the core issues of interpretation of the regulations since they seem to be interpreted differently by many. Also Sheppard Mullin & Company, Attorneys at Law in the Beauty Industry, give an excellent representation of how difficult it is for the FDA to clarify standards when Federal Courts find in favor of the manufacturers in terms of their product descriptions. Plus the courts are careful to not employ censorship in their legal decision!

FDA and FTC: Comparison

Medical Claims: A Big No No

It is clear, certain claims on cosmetics cannot cross the line of OTC (over the counter) drugs, such as making claims that using a certain skincare or makeup product will heal or cure something without the proper clinical trials. But as to how far a company can go in conveying an intended purpose is the fine line that many cross, perhaps unintentionally. However, there are also those that make ridiculous claims and this invariably becomes a blatant violation of FDA Regulations. Literally, no room for interpretation! And for those that practice this, it gives our industry a "black eye" even though there are many that do not practice this level of questionable marketing tactics.

Example: Using Essential Oils and making the claim that symptoms of multiple sclerosis or parkinson's disease are improved, or are all but gone by simply massaging the oil into the skin.

This isn't to say that some haven't found relief with holistic medicine in the form of ingestion of herbal remedies, but there simply isn't any incontrovertible evidence of the other method working. And as some studies show, placebo effects may have similar result. The mind is a powerful tool! Plus FDA requires the proper trials for FDA approval as an OTC drug when making such a claim.

As a blogger also, it was important to have facts in all cases when necessary.....FDA stated that ingredients can be remarked on as to their reputed properties showing their benefits in the holistic medical community through decades of scientific research. Whereby I created an ingredient glossary depicting their attributes of a specific ingredient, but did not make a medical claim on the actual product. But now, only to learn again from another FDA source that my ingredient glossary cannot contain descriptives which imply healing or curing at the same site as where products are purchased, even though I never made a claim as to the overall product itself. But as it was explained to me, the inference of a benefit from an ingredient and its' inclusion into a product means the same thing to the FDA.

Also, the FDA has been notorious for changing the rules when they deem it necessary, and due to some of the vague language in times past, and only targeting some companies for violations, even when they provide sound science, while allowing others to basically continue with false claims, has been a bone of contention among the naturalists in the vitamin and natural foods community. This article is a prime example of such action. Alliance For Natural Health, Cherries and Walnuts!

The Alliance for Natural Health brought suit against the FDA and won. What they argued was on the premise of censorship of holistic / medical benefits of a certain ingredient for staving off cancer, literally preventing display of the scientific research to back up the claim. This ruling was important since it help set a precedent for the naturalists and to prevent FDA from censoring information which maybe in direct conflict with big Pharma. Alliance for Natural Health Story of this landmark case. The judge in this case, in effect, said that food and dietary supplement producers have a right under the free speech doctrine to talk about the science behind the product so long as they accurately represent that science.

Perhaps one day we can enjoy the same within the cosmetic industry in regard to natural skincare since many consumers through testimonials and clinical trials, have seen improvement using natural products versus using prescription topical creams, whether for reducing signs of aging or for a skin affliction. This is something to certainly look forward to.

Looking In Another Direction For Clarity

However, until such time, instead of dealing with the FDA, I looked to the FTC (Federal Trade Commission) for clarification. Their language is not is straight forward, to the point, and no room for interpretation.....Hallelujah!

Basically, the FTC states that no products offered as a cosmetic can be represented as curing or healing, including providing ingredient lists with the inference of doing same for its' intended purpose. Complete controlled clinical studies must be performed on the combined formulation of ingredients since potency and efficacy may not be retained, or may be altered from the individual ingredients' purported benefit, depending on composition of the completed formula.

Natural Sunscreen Claims

The same goes for SPF claims in mineral makeup or other skincare products without the FDA testing required to prove benefit. This testing is not only expensive, but it is also subjective to how much of a product is applied, rarely achieving the actual SPF Rating due to application technique.

Mineral Powders for instance, rarely will reach the levels claimed due to how little is used, and is a key factor in not pursuing our SPF Rating at all. Yet you see a multitude of mineral makeup companies making this claim....such as on average an SPF of 15-25 can be is a great guess and I am sure it is based on their own experiences or on product trials as it was with my minerals when we launched, but apparently even estimates cannot be shared without the clinical studies. I have since removed this verbiage from my site.

Most common sense dictates what titanium dioxide and zinc oxide are used for, and the FDA endorses these as broad spectrum sunscreens through scientific research, reflected in the fact they are approved as an OTC drug for UVA and UVB protection, listing these two ingredients as "active" on the label. So the incontrovertible scientific research is there on these ingredients.

However, without the clinical tests performed by each independent company selling products containing these ingredients, they cannot even make a claim to offering natural sun protection, based on what I stated above. I totally understand the SPF claim without testing since sunscreen ratios change from product to product, regardless of SPF determination, they still are natural sunscreens in any context.

Government is clearly not perfect and doesn't always make any sense. Personally, I see it as a way to gain more revenue from the cosmetic companies by imposing these regulations to this degree even though the research of Titanium Dioxide and Zinc Oxide has already been done by others showing their natural properties for protecting skin from the suns' harmful rays, and have gone through the FDA approval process.

The article from ANH Lawsuit clearly explains the ulterior motives FDA may have, comparing the same analogy that no one can obtain a patent on these two ingredients, so why go through the expense of duplicating testing only to come up with the same result of being able to state they offer natural sun protection.

Redundancy seems pointless to me! Perhaps someday this too will change as censorship of data is further explored within our industry. The Vitamin and Natural Food industries are certainly taking a stand based on "qualified" claims.

The same thing goes for individual ingredients, as they also cannot be described as anti-inflammatory, antibacterial, antimicrobial, antiseptic, anti-fungal unless noted in a preservative context. Otherwise it gives the inference that it will do something for problem skin. I have also removed this language from my site.

Are we aware of what organic and natural ingredients offer in overall health benefits?....Most of us are! Do we recognize their Holistic properties as provided by other resourced data?.... Most of us do! Can I claim it on my site and shout it from the rooftops?....NO!

Most of us know there are age defying ingredients being successfully used with proven results in clinical studies and we can see and feel improvement on our skin. I mean, think about it, if the benefits of an ingredient didn't perform in the manner of which it is intended, then we all might as well smear Vaseline or Olive oil on our skin and call it a day. This is certainly a conundrum!

So, in accordance with FTC mandates, this is where I will comply since nothing is open to interpretation and I thank this entity for clarifying the issues for me, not only as a manufacturer, but as a consumer as well. I may not agree with these rules, but I will abide by them.

Let me clearly state this is being done voluntarily and I have not received any "warning" letters from FDA or FTC. I simply wish, as always, to conduct business in a transparent and ethical manner. Truth in Labeling continues to be a part of my business ethic, even if the scientific truth about ingredients cannot be displayed.

Customer Testimonials

I love receiving all of your letters telling your stories of how our products worked for your skin whether it behaves normally and functions to perfection, or you're someone who struggles with a skin affliction. Regardless of how wonderful you think our products are, the FTC states, we can't allow testimonials on our site which contain raves claiming that our products cured, cleared up or healed the affliction. In doing this, it connotes it is an OTC drug!

The FDA doesn't even touch on this anywhere on their site, yet call them, and they find no ruling against placing testimonials on my site.....but a return phone call within 15 minutes of my initial phone call to them, they stated, I can't put testimonials on my site with a medical claim, (I guess they checked with the powers that be).... but added I can discuss and place them at my blog.....huh?!

And it should be noted in avoidance of censorship, based on journalistic pursuits which is what my Skin Care Guide is for..... I can present reputed benefits and scientific data about individual ingredients when it is available, when constructing one of my many articles on skin health. But yet again, this may allow the FDA to change the game when necessary by not having a distinct outline or clarification of the rules. When asked for a list of what I can and can't say.... they simply wouldn't commit in this regard.

However, keep those testimonials coming and I'll keep searching for the truth and writing about it. And, if someone else writes a blog and tries our products, as in the past, and wants to convey their findings as to how our products performed, then this is out of my control. The FTC or the FDA are not concerned with bloggers who bear no relationship to the companies they enjoy using and writing about their products, unless they are endorsing the company they are reviewing based on receiving some form of payment or Free trial products, then they must disclose this fact to the public.

Be aware though, if you should enclose a testimonial to us which contains language which could be construed as implying our products are OTC drugs, then this part will be edited out and you will see at the bottom of the testimonial, "Edited For Content Due To FDA Regulations."

So this is why pages are now removed, some testimonials are edited, and ingredient listings are order for my company to be in compliance with the FDA, as ambiguous as they are. I will always continue with updating the site anytime something new is learned within my industry.

So I wish everyone continued enjoyment of our products and the benefits you feel they offer your skin and complexions, and it will just be between us as to, if any, improvement one may reap when using them. Because, "I know what I know, and I know based on historical clinical findings of ingredients used"!

Cheers! And Happy 4th of July!

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