Sunday, September 16, 2012

Labeling Claims

Not much is more confusing to consumers than product claims regulations. Let's not mention how it may confuse some formulators. 
Questions with respect to the rules :

 1. What level of proof is required?
 2. What claims can be made and who decides?
 3. What are the penalties for making a false claim?
 4. Who/ what is responsible for  regulating the claims?

Plenty of regulations are in place, however with the lack of enforcement behind them, it makes precious little difference. How does it occur ? Without uniform consistent enforcement, companies can claim to not be aware of  which rules to follow or what they can legally state. As the regulations are not enforced, self regulation goes out the window while they chase their nearest competitor's latest wild claim.

Let's take a look at what actually goes into the product's ingredients list: Only INCI names are allowed on cosmetic product labels. That should not be a mystery. It's also what a DIY'er will exploit should they choose to. Due to the ball dropping act of lack of  enforcement of the rules, companies are free to list all sorts of claims in their ingredient statements though. The tricky question at the end of the day, are consumers reading the ingredients or only the cosmetic chemists? Apparently both.

Of these  horrific errors in labeling, purified water , deionized water, natural spring water, is the most common. Purified water is the drug name for water, as defined in the US Pharmacopoeia, and is reserved for use on the labels of drugs that do not make cosmetic claims. Calling water anything but water, is an infraction, but we see it all the time. Using  'vitamin' is another illegal advertising claim on cosmetic ingredient labels. And where have we seen that? Vitamins are categorized separately  from cosmetic ingredients as they are not recognized as providing  benefits in a cosmetic product according to the FDA. Oddly enough and with some strange lack of reason the FDA does not object to stating  the product contains  vitamins outside of the ingredient listing. ( if you do this does it make it outside? )

Terms like vegetable, natural, organic, or of  even greater emotional impact,(*)  certified organic, is another label marketing twisted trend that is intended to highlight the "natural" origins of ingredients. Some marketers further emphasize this delight by inserting an asterisk (*) within the ingredients list to call attention to materials in the product that are of this highly pedigreed origin. Whether of natural or synthetic origin, they are still chemicals.

Juice Beauty The Organic Solution.
Juice Beauty Stem Cellular Repair Booster Serum

Scientific Technology, Organic Innovation, Ultimate Results

An ultra-light gel serum power packed with an optimum dose of our proprietary blend of fruit stem cells and a potent dose of Vitamin C infused boosts the skin's ability to repair and renew cellular turnover. Formulated to enhance the performance of the Stem Cellular Repair Moisturizer by improving its ability to penetrate the skin and maximize the results at a cellular level to increase dermal firmness and eliminate deep wrinkles.

Those are some fancy claims based on this ingredients list for that bit of merchanise. And this list, is repleat with every marketing trick in the book, including  those that ride the razor's edge of the rules. They make great use of images and stories of wonder about the organic ingredients, what they supposedly contain, the reality is quite different. If one were to quantify it, it would add up to subclinical levels.

Juice Beauty proprietary blend of fruit stem cells: apple buds, grape buds & lemon bark. Ingredients: Organic juices of pyrus malus (organic apple juice)*, vitis vinifera (organic white grape juice)*, citrus medica limonum (organic lemon juice)*, aloe barbadensis (organic aloe leaf juice)*, vegetable glycerin, organic plant oils of helianthus annus (organic sunflower seed oil)*, simmondsia chinensis (organic jojoba seed)*, butyrospermum parkii (organic shea butter)*, octyl palmitate, caprylic/capric triglyceride, glyceryl stearate, magnesium ascorbyl phosphate (Vitamin C), stearic acid, cetearyl alcohol, malus sylvestris (apple buds), vitis vinifera (grape buds) & citrus limonum (lemon bark), organic essential fatty acids of oenothera biennis (organic evening primrose oil)*, linum usitatissimum (organic linseed oil)*, borago officinalis (organic borage seed oil)*, xanthan gum, panthenol (Vitamin B5), allantoin, sodium hyaluronate (hyaluronic acid), tocopherol (Vitamin E), sodium benzoate, potassium sorbate, ethylhexylglycerin, citrus reticulata (mandarin), litsea cubeba (may chang) and cinnamomum camphora (ho wood) pure essential oils *certified organic by a USDA approved agency

Optimum does of Vitamin C for DNA repair. Prepares the skin for the Stem Cellular Repair Moisturizer.

And a new mechanism of DNA repair has arrived in the form of  MAP. I do like MAP, but not for that reason.

There is no difference in chemicals from 'natural' or synthetic origins. Hyaluronic acid from which origin? It's found in animals, cocks combs and animal hooves is a primary source. Not popular. Call it bioengineered, bacterial production method, and all is well. Preferable to many. Glycerin shares the same strange story. (*) certified organic glycerin is chemcially no different, nor preferentially treated by the skin, than is synthetic. Albeit of the two, I will defineitly err on the side of the bioengineered HA.

Clinically Validated instrument measured Stem Cellular Repair Results

    100% improved hydration
    96% improved dark circles and puffiness around eyes
    88% reduction in 3D visual analysis of fine lines and wrinkles
    88% improved skin tone and luminosity
    75% improved elasticity of the skin

Really? Where are these clinical validations? Non existent. Claim. Unfortunately, it seems that the "natural/ organic" crowd are the some of the worst offenders with regards to labels and claims. Much as I prefer natural, they give natural cosmetics a bad name. The list above includes several "non natural" and non organic ingredients, but call it all organic anyways. Doesn't matter, it sells. Don't forget "proprietary blend of fruit stem cells", perhaps they didn't want to go so far as labeling  "Patent Pending" because there is nothing there. Utter bunk.

Slather On Your Vegetables

Juice Beauty, they seem to have nice products. It is only an example of what pops up in google with  labeling and claims when hitting "true organic aging  labels." Deep wrinkle eliminating? No.

The distinction between drugs and cosmetics is based principally by the promoted intent of effect of the product . If the claim suggests  a product to have drug-like effects, that product will be regulated as a drug. This ruling based on intent is subjective as is more than clear by the outrageous claims that usher in the new latest and greatest actives and products.  Drug vs. Cosmetic Claims in the USA,  ought to keep the FDA busy for the next century.

"Elimination of Deep Wrinkles" ?? Would that not qualify? That's more of a plastic surgery claim. It's not explicitly covered in the FDA labeling requirements, and as is obvious, self regulation went out the proverbial window.

Cosmetics that are also Drugs

Products that are cosmetics but are also intended to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), hormone creams, suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.
Most currently marketed cosmetics which are also drugs are over-the-counter drugs. Several are new drugs for which safety and effectiveness had to be proved to the agency before they could be marketed. A new drug is a drug which is not generally recognized by experts as safe and effective under the conditions of intended use or which has become so recognized but has not been used to a material extent or for a material time under such conditions.

To further complicate the matter, different jurisdictions allow different types of claims. Health Canada is known for being rather strict, but minimum they provide a list of what constitutes acceptable claims for cosmetics. The claims must be accurate, true and verifiable.
Guidelines for Cosmetic Advertising and Labeling Claims

The European Union takes this a step farther and states that a company must have proof of the effect claimed for the  product. If claims exist the company then most also make available on the packaging an EU address that the Competent Authorities may contact in order to inspect evidence of the claims made. One would be erroneous in assuming that the competent authority is the consumer.
Cosmetic products (until 2013)

Proof of Claims is expensive, most companies prefer to make claims without doing the work or shouldering the cost. Cuts into the bottom line rather deeply. Unfortunately they rely almost solely upon the  ingredient suppliers claims. The National Advertising Division of the Council of Better Business Bureaus, in the USA acts as big brother for all  advertising claims. In theory they do not accept ingredient claims as a base for finished goods claims. But you would be forced to accept quite the contrary when reading the plethora of advertisements that are clearly in opposition . In the EU, ingredient suppliers’ claims are being accepted as long as the cosmetics company use the exact same ingredient  at the exact same dosage in a formulation. In future, this is most unlikely, but who knows?

Reading through EU legalese is a migraine inducing activity. The FDA is  light reading by comparison. Health Canada, simple. DIY, total freedom, where none of the above applies.