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This section will provide you with a working knowledge of the many regulatory issues that affect natural products and the information about those products you can share with your customers.

8.1 Organic

Organic certification for personal care products has been a trying process for companies committed to providing certified organic products. After allowing personal care products to be certified as organic under USDA regulations for several years, the National Organic Standards Board (NOSB) ruled in the spring of 2004 that the USDA organic seal could no longer be used on personal care products.

Essential oils, as an agricultural product, could be certified organic as long they were sold for food use, but no aromatherapy products could be certified organic. Even the same organic essential oils, if packaged and labeled for aromatherapy or cosmetic use, could not be USDA certified organic. This clearly contradictory policy was met with a lot of criticism, feedback and even a lawsuit. The lack of regulation also opened the door to fraudulent organic claims in the personal care marketplace.

In late August of 2005, the USDA issued a memorandum to all certifying agents that products "including personal care products, that, by virtue of their organic agricultural product content, may meet the NOP standards and be labeled as '100 percent organic', 'organic', or 'made with organic' pursuant to the NOP" could once again carry the USDA organic seal.

Personal care products that are USDA certified organic must comply with all regulations, including using only ingredients that are USDA approved for use in organic foods. Because products like shampoos often include various chemical components that are not approved for use in organic foods, these products are not be able to be USDA certified organic under the August 2005 rules.

There is an industry task force working to develop rules for organic certification of personal care products that is considering which types of chemical ingredients should be acceptable for use in organic personal care products. But until such guidelines are finished and adopted by the USDA, only personal care products that meet current standards can be certified.

The bottom line is that once again retailers can be assured that USDA-certified organic personal care products don't contain any unacceptable chemical ingredients. You should carefully read all ingredient statements of personal care products making organic claims that aren't USDA certified.

8.2 Labeling and Label Claims

Aromatherapy products are regulated by the FDA (Food and Drug Administration) as cosmetics. This creates certain problems in labeling and assisting your customers with understanding the health benefits of these products. Aura Cacia labels all products in compliance with regulations in order to protect you and your customer – that’s why you will often see competing products making claims or statements about the product’s supposed benefits that you won’t see on an Aura Cacia label. The types of claims you may see on a label or in product literature are explained below.

1. Drug claims. These are claims such as the product treats or cures cancer, bronchitis or any other disease for which prescription drugs are used.

2. OTC claims. Over the Counter drugs are drugs that can be sold without a prescription. These are for conditions that are considered by the FDA to be self-diagnosable and self-treatable with a low risk of abuse or misuse of the drugs. Each condition is a separate therapeutic category and there are over 80 categories such as cold and flu, cough suppressant, anti-wrinkle, sunscreens and acne. If a product is making an OTC claim, check to make sure it is an OTC product. This will be evident because it will include the active ingredient (which will be an ingredient approved for use in that OTC category).

3. Structure/Function claims. Many cosmetic and aromatherapy companies have tried to adopt structure/function claims in their labeling. However structure/function claims are only applicable to dietary supplements and do not apply to cosmetics. So claims such as “provides support during cold and flu season” are not allowed for aromatherapy or cosmetic products.

4. Insect Repellant claims. The EPA (environmental protection agency) regulates the use of pesticides and insect repellents. Even if they approve an essential oil such as lemon eucalyptus or citronella for use as an insect repellent, products making such claims must be registered and approved by the EPA before they can be sold.

So what can you say? Soft claims, or statements that provide an emotional or general benefit are acceptable ways to describe an aromatherapy product's uses. It takes some creativity to give the consumer information about the benefits of a product without crossing a legal line. Here are some examples of the type of language you can and can’t use in describing a product’s benefits.

And you can always point an inquisitive shopper to your book section or recommend some good aromatherapy books from your own experience.

8.3 Ingredients

Cosmetic products are not required to identify all the ingredients in the product. Exceptions are made for incidental ingredients, ingredients that are classified by the FDA as trade secrets and for fragrance. When checking the list of ingredients in aromatherapy products, assume that any product that lists “fragrance” includes some or all synthetic fragrances. Aura Cacia and other reliable companies list the essential oils used in their products. (Of course, even when an essential oil is listed as an ingredient, if it's adulterated with a solvent, synthetic oil or another essential oil, you won't find the adulterants listed as ingredients on the label.)

8.4 How Regulation Affects your Store

It is the manufacturer’s responsibility to label their products to be in compliance with all regulations (labeling includes the product label as well as any accompanying sales or promotional literature). However, the retailer can also bear some liability for selling products and providing information that is not in compliance with regulations. There are many herbal, aromatherapy and supplement products being sold today that don’t meet government label standards or make illegal or unsupported claims. This is because regulatory bodies such as the FDA, EPA, FTC and USDA don’t have the funds to go after every non-compliant product in the marketplace. And because a company has competitors who are selling these non-compliant products, the temptation is to level the playing field by doing the same—and this leads to even more non-compliant products. In your store, you may also face strong pressure by your customers to provide products and information, or to give advice about how to treat a medical condition. Companies do get into trouble with regulatory agencies and are sometimes forced to recall products, change labels, pay fines, have inventory seized or in extreme cases executives may find themselves serving jail time. On the store-level, an occasional warning or fine is levied.

Besides the risk of regulatory action, there are other reasons to comply with regulations:

To prevent over-regulation. When a class of products is generally complying with regulations, the products that are out of compliance are seen as renegades and enforcement actions are limited to the offenders. When non-compliance is widespread within a class of products, regulatory bodies see this as a problem with that industry. This can result in much greater regulation and loss of good products and companies.

For consumer safety. Regulations can seem too restrictive sometimes, but they can help protect consumers from unscrupulous companies making false or misleading claims or selling potentially harmful products.

Some tips to follow when choosing aromatherapy oils and products for your store.

• Make sure any essential oils you carry that don’t have child resistant caps are displayed where little hands can’t reach them. Aura Cacia and Frontier essential oils have child resistant caps, except for the Aura Cacia Organics, which will convert when we run out of our current cap.

• Carry essential oil lines with appropriate safety information on the label. Consumers can forget the important safety information you give them if it isn’t on the bottle.

• Essential oil bottles with drop-by-drop dispensing systems help prevent overuse of the oil. And if a child does get into the bottle, the dispenser will control how quickly the oil will come out of the bottle and can limit a child’s exposure to the oil.

• Avoid diagnosing, prescribing or treating a customer. If someone takes your advice, and isn’t helped, gets worse or is harmed, you and your store can be in serious trouble. To be safe when talking with customers about the benefits of essential oils, use emotional attribute terms like “soothing, uplifting and relaxing.” Or talk about cosmetic benefits like “helps to open and cleanse pores” or “moisturizing and balancing.”

• Don't encourage the internal use of essential oils. While many oils can be used internally safely, they are highly concentrated, and it's important to know when to take, how to use and how much for each oil.

• Carry only essential oils and aromatherapy products from reputable companies with guaranteed 100% pure oils. Adulterated or mislabeled essential oils may pose greater risks than pure or properly identified essential oils. And the botanical name should be included on the label as well as the common name to insure proper identification of the oil to the consumer.

8.5 Regulatory Terms

Here are some key regulatory terms you'll want to be familiar with:

Cosmetic: Articles intended to be rubbed, poured, sprinkled, sprayed or introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance (other than soap). Most aromatherapy products fall into this category.

Drug: Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or animals. An OTC drug is an over-the-counter drug that is deemed to be safe when used without a doctor’s prescription or supervision. OTC drugs may be used where the condition is capable of self-diagnosis, self-treatment and is usually self-limiting. Some “aromatherapy” items which are sold as cosmetics make OTC drug claims such as "cold and flu bath," "anti-wrinkle lotion" or "acne cream." OTC claims can only be legally made for products that are registered and approved as OTC drugs and labeled in compliance with OTC regulations.

Label: Any display of written, printed or graphic matter on the immediate outer or inner container of a food, drug or cosmetic products.

Labeling: All labels or other written, printed or graphic matter upon any article or its containers or wrappers or accompanying the product. This includes a product brochure, shelf talker, and literature on or near the product.

Review Questions Section 8

1. Under what category of products are most aromatherapy products regulated?

2. What types of claims are allowed and not allowed under this category?

3. Why is it important for responsible companies to comply with applicable regulations?

4. Do retail stores and store personnel have any responsiblity for selling products that comply with regulations?