Wednesday, December 10, 2014

Ten Facts about the FDA and Hair Products : Finding out how hair products are regulated for your safety and Monitoring hair growth drugs and devices

Ten Facts about the FDA and Hair Products

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In This Chapter

  • Finding out how hair products are regulated for your safety
  • Monitoring hair growth drugs and devices

In the United States, it’s common to assume that the U.S. Food and Drug Administration (FDA) looks out for consumer’s welfare

when it comes to hair products, from over-the-counter drugs to medical devices for stimulating hair growth.

But does it? As this chapter reveals, the answer is both yes and no. If you’re wondering what the FDA’s mission is, here is its mission statement:

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Sounds like some lofty goals and really big jobs, and they are. But, not too surprisingly, the FDA can’t be everywhere all the time, which is why contaminated medications, tainted food, and dangerous devices do occasionally make it onto the market. However, the FDA does its best to keep things safe.

What is the FDA’s involvement in hair loss issues? Well, snake oil salesmen and charlatans still have no trouble pedaling their products to hairless and desperate consumers. In this chapter, we look

at the myths and truths about what the FDA does and doesn’t do when it comes to hair loss.

It Doesn’t Approve Shampoos and Conditioners

Yes, it’s true — the FDA wants you and your dermatologist to know what’s in your shampoo and conditioner and mandates that sham- poo and conditioner manufacturers list all ingredients on the backs of the containers. The agency also prohibits manufacturers from making any false claims about what your shampoo or conditioner can do for your hair.

Most shampoos and conditioners are regulated as cosmetics, which means that companies can put them on the market without prior FDA approval. This fast-track to store shelves doesn’t mean cosmetics are unsafe. In fact, most shampoos and hair conditioners are perfectly safe when used as directed. Care should be taken to keep shampoos out of the eyes because that, as you know, can cause stinging. Some consumers who use the same shampoo for years can develop an allergy to it and should switch to another brand.

However, not all shampoos and conditioners are created equal. Shampoos that contain ingredients designed to treat conditions such as dandruff or psoriasis are regulated by the FDA as drugs, not cosmetics, and that means those shampoos are subject to more extensive regulations, as discussed later in this chapter.

It Doesn’t Approve Most Permanent Hair Dyes

As we explain in Chapter 3, there are three types of hair dye:

  • Permanent
  • Semi-permanent
  • Temporary

All three types can contain coal-tar dyes, potent chemicals that can cause potential safety problems, including irritation and allergy. Note that “Coal-tar” dyes are not really made from coal-tar any- more. They are made from petroleum but the old name is still found in FDA regulations and FDA laws.

One type of permanent hair dye is the “progressive” type. This dye contains either lead acetate or bismuth citrate, both of which have been approved and listed in the Code of Federal Regulations for coloring scalp hair only as a result of petitions submitted to the FDA. Henna has also been listed.

Unlike color additives used in other cosmetic products, Congress exempted oxidation-type coal-tar hair dyes from its listing and certification regulations. In such cases, all the agency can do is require adequate directions for preliminary patch testing by consumers for skin sensitivity and that the following warning statement appear on the label:

Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.

Since anyone can become sensitized to hair dyes with time, patch tests are urged each time before a consumer intends to use an oxidation hair dye.

Oxidation (or “coal-tar”) hair dyes contain synthetic organic dyes and dye intermediates made from petroleum that penetrate the hair shaft in the presence of hydrogen peroxide and ammonia. This results in a coloring of the hair that lasts a long time.

A few permanent dyes have been shown to cause cancer in animals.

Progressive hair dyes are made with lead acetate, or less frequently, bismuth citrate. These FDA-approved dyes gradually darken the hair by oxidizing on the hair surface and reacting with the sulfur in the keratin of the hair shaft. (Refer to Chapter 2 for an explanation of the structure of hair.)

Semi-permanent and temporary dyes also contain coal-tar dyes, but they adhere to the surface of the hair shaft for much shorter periods of time than permanent dyes.

FDA Gets Help from the Courts to Protect Consumers

It’s no surprise that the FDA gets the most complaints from consumers about hair relaxers (straighteners) and hair dyes. Each contain powerful chemicals that can cause harm, especially if used incorrectly by consumers that do not understand the risks.

The FDA tries to inform the consumers to take a proactive approach in using such products safely. The agency also reviews consumer complaints and, when it finds a pattern of unusual or severe reactions, it conducts an investigation and requests a company to voluntarily remove the product from the market. But the agency doesn’t have pre-approval authority for cosmetics and sometimes needs help in getting an unsafe product off the market.

Take the example of the World Rio Corporation of California. It marketed two hair relaxers, the Rio Naturalizer System (Neutral Formula) and the Rio Naturalizer System with Color Enhancer (Black/Licorice). Consumers had complained to the FDA about hair loss, scalp irritation, and discolored hair. The FDA requested that the company cease marketing these products. In December 1994, they agreed to stop sales and shipments of the products.

The FDA discovered, however, that the company had continued to take orders. The California Department of Health then also asked them to stop sales. Finally, in January 1995, the U.S. Attorney’s Office in Los Angeles filed a seizure action against these products on behalf of the FDA.

In the resulting consent decree of condemnation and permanent injunction, the FDA noted that it received more than 3,000 com- plaints about the Rio products. The agency alleged that the products were potentially harmful or injurious when used as intended, that they were more acidic than declared in the labeling, and that the labeling described the products as “chemical free” when “allegedly they contained ingredients commonly understood to be ‘chemicals.’”

Hair relaxers (known also as hair straighteners) are generally alkaline rather than acidic products. Lye or another strongly alkaline chemical is used to break the bonds in the hair. Lye can cause burns to the scalp if left on too long or not properly washed out with shampoo and conditioner. Getting help from someone else in applying and removing the relaxer can help ensure all is removed and neutralized.

Since lye can cause burns to the face, lungs, and esophagus if swallowed, parents are urged to keep this product out of reach of children. When using a relaxer on children, be especially careful to keep it off the skin and out of their eyes.

Since hair relaxers can result in hair breakage, baldness, burns, and emergency room visits, special care is urged when using these products. Some people use petroleum jelly on their heads to form

a protective barrier before using a hair relaxer. A neutralizing shampoo should be used after treatment, followed by a hair conditioner. Consumers should avoid scratching their heads or brushing hair before using a relaxer.

And don’t leave the relaxer on too long! Using a relaxer too frequently can damage the hair. It’s also not a good idea to use a permanent oxidation (coal tar) dye the same day as you use a hair relaxer because the chance of hair damage increases.

It Protects You from Cosmetic Hair Growth Product Scams

In 1989, the FDA, concerned about consumer gullibility, banned all topical lotions, potions, creams, and other cosmetic gunk that claimed to grow hair where there was no hair. However, these products have now begun to crop up on the Internet. From the FDA’s perspective, shutting down these scams must be like picking fleas off a dog — every time they remove one, another one jumps up.

The bottom line? No matter what you see and hear on late-night TV, a product can’t grow a single hair on your head if you have nothing to start with. You can write to the FDA or Federal Trade Commission (FTC) to complain about such products. The FDA regulates labeling claims while the FTC regulates advertising.

It Approves All Prescription Drugs That Claim to Grow Hair

You can rest assured that any new prescription drug claiming to grow new hair has been thoroughly tested in clinical trials. After a certain number of years, though, the patent on brand name drugs expires, and other companies can manufacture the same drug under a different name as a generic drug.

For example, under the brand name Proscar, finasteride was manufactured by Merck and originally covered by U.S. and international patents to treat benign prostate hypertrophy (BPH). A separate patent for the drug was issued to treat male pattern baldness under the name Propecia.

Finasteride is now off-patent for use in treating BPH and is sold under several generic names. Propecia won’t be off-patent until 2013, at which time generic versions will undoubtedly appear.

Because generic drug makers don’t develop a drug from scratch, their costs to bring the drug to market are much lower, but they must show that their product works in the same way as the brand- name drug. No clinical trials, however, are required. All generic drugs are approved by the FDA, and the FDA assures the public that they’re equivalent to the original medications.

It Doesn’t Pre-Approve Over-the- Counter Hair Growth Drugs

Drugs that are sold over-the-counter (OTC) aren’t subject to pre- market FDA approval, but it does oversee OTC drugs to ensure that they’re properly labeled and that their benefits outweigh their risks. There are more than 80 classes of OTC drugs, including prod- ucts for hair growth and loss, antifungal products, sunscreen, and weight-control drugs.

Particular classes of OTC drugs are subject to a monograph system. Monographs specify the active ingredients, labeling, and testing required for the particular class of drugs. For example, if you want to market a sunscreen, you can follow the sunscreen monograph and go to market without submitting anything to the FDA (except manufacturer registration and drug listing information). However, if you want to add substantial new claims to a new sunscreen or change the percentages of active ingredients that appear in the monograph, you need to submit a very expensive new drug application for FDA approval. The monograph system is a convenient one for most manufacturers, but it does inhibit development of improved products.

The FDA published a report in 1989, the Final Monograph on Hair Grower and Hair Loss-Prevention OTC Drug Products for Human Use, after a review of safety and efficacy data submitted by interested companies. The FDA was, to say the least, unimpressed with what it received, and the Monograph stated, “There are no agency- approved OTC hair loss prevention drug products” and warned companies not to market such products unless they want to risk FDA action.

That’s why you don’t see OTC drugs with hair loss prevention claims in your pharmacy.

It Prevents Dietary Supplements from Claiming to Cure Hair Loss

A dietary supplement is defined as “a product taken by mouth that contains a ‘dietary ingredient’ intended to supplement the diet.” Dietary supplements can be extracts or concentrates and may be found in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders.

Manufacturers of dietary supplements usually don’t need to register their products with the FDA and generally don’t need FDA approval before producing or selling dietary supplements. The Dietary Supplement Health and Education Act (DSHEA) instituted in 1994 says that the FDA is only responsible for taking action against an unsafe dietary supplement after it’s on the market.

It’s illegal to market a dietary supplement product as a treatment or cure for a specific disease or condition, such as hair loss. Many supplements and herbal remedies are nevertheless illegally advertised as being able to cure hair loss. If you see a topical dietary supplement with such claims, you can be sure that it’s illegal.

Advertising claims are regulated not by the FDA but by the Federal Trade Commission (FTC). When a product has been proven unsafe, such as what happened with Ephedra, the FDA can order it removed from the market. But before that point, it’s up to you to be a careful and sensible consumer when buying supplements.

It Doesn’t Require Much from Class I Medical Devices

Medical devices fall into one of three classes with increasing complexity and potential risk. Class I devices aren’t intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health. They also can’t present a potential unreasonable risk of illness or injury.

Medical devices are usually exempt from premarket notification submission requirements (the 510(k), a lower standard than FDA approval that comes from an abbreviated process). The author (Dr. Rassman) produced a medical instrument, ‘the hair implanter pen (HIP)’ and this is an example of such a class I cleared device.

It Requires Clearance for Class II Medical Devices

Class II devices, including those for hair growth, require special labeling and are held to a higher standard than Class I devices; sponsors of the 510(k) must show the FDA that the proposed device is at least as safe and effective as similar legally marketed products in the U.S. Devices in this class are typically noninvasive and include products like low-level laser therapy devices that claim to grow new hair (http://en.wikipedia.org/wiki/ Medical_device - endnote_FDA3132). Most Class II products require 510(k) clearance, which is a lower standard than FDA approval.

One device that went through the 510(k) process and is now touted on many Web sites as “FDA approved” is the low-level laser treatment for home use, called the HairMax LaserComb(r). The sponsor made the medical claim that this medical device could grow hair, and that claim had to be addressed by the FDA before the product could go on the market.

Because the LaserComb is a Class II product, the company only had to show that it was as safe and effective as similar

legally marketed U.S. products. Only one study was done to show that the LaserComb was safe and effective before it was cleared for marketing.

It Requires Thorough Testing and Trials for Class III Devices

Class III medical devices need to be thoroughly tested in clinical trials to ensure their safety and effectiveness over and above the Class I and Class II controls. Examples include coronary heart valves and stents. Hair care products and devices don’t fall into the Class III category unless someone invents something that’s life- supporting or life-sustaining and also grows hair.

Currently, with one exception, the hair-growing tools sold in your local drugstore or big box store aren’t likely to be FDA approved or even to have FDA clearance because their claims are limited and their risks are low.