The key to substantiating claims

Failing to follow FDA and FTC rules in advertising and marketing comes at a cost — as more and more companies are finding out the hard way. Douglas S Kalman, MS, RD, explains the best way to scientifically document and support your product?s health claims, and steer clear of the regulatory radar

For years, the automobile industry was plagued by a reputation it often deserved: customers would go to a used car lot and test-drive a car that would hum perfectly. But not long after they plunked down their money, the car would be found stalled on the side of the road.

After an almost epidemic of bad cars being sold, many states enacted laws to protect buyers known as ?lemon laws.? If a car turned out not to be what it appeared to be, if a company?s advertising was not substantiated, the consumer had recourse.

Can you think of other industries that may also benefit from a lemon law?

If you read an ad for a dietary supplement that states ?other natural supplements treat only 15 per cent of pain,? would you believe the product being promoted remedies all pain? You might. When consumers compare products? efficacy, once a specific effect has been mentioned in marketing, there is a further need for claims substantiation. Otherwise, a lawyer or regulatory agency might say the advertisement is playing fast and loose with the scientific record.

Another common advertisement we see is for a compound purported to ?reduce stress, improve sleep quality, diminish PMS, enhance mental sharpness and reduce negative side effects of caffeine.? This branded ingredient is popular and found in many products. The studies on this ingredient, however, have been carried out mostly in Japan. So one may wonder then: do studies carried out on people who have different geno and phenotypes than the majority US population have the same implications here? Does the research touted substantiate the claims made in the US market?

The FDA indicates that foreign studies may not have equivalence for US substantiation but will be considered part of the portfolio
The current Draft Guidance for Substantiation released by the Food and Drug Administration in November 2004 addresses this very issue. In fact, the FDA indicates that foreign studies may not have equivalence for US substantiation but will be considered part of the portfolio. This is surely something that must be a consideration for any dietary supplements company.

Legal precedence
In January 2002, the FDA issued guidance regarding claims and compliance guidelines. According to the Guidance for Industry regarding structure/function claims, claims can be made on or for dietary supplements if you have substantiation that the claims are truthful and not misleading. The substantiation must be in place prior to the claim being made, and in fact, the FDA is to be notified within 30 days of first marketing the product.

So, while there is clear guidance regarding what constitutes a structure/function claim (for more information, see the set of 10 criteria in section 101.93(g) of Title 21 Code of Federal Regulations), it appears from the above two product advertisement examples that these laws are not being followed. Section 101.93(g) of Title 21 contains guidance regarding claims, and this section keys in on disease or symptom claims, implied claims and much more.

This is of utmost importance because the document contains clear guidance regarding what a company could say or how a company could structure the label, advertisements and other product-supportive literature. However, the lack of clarity as to what exactly constitutes substantiation is a concern. Imagine you had one small-scale pilot open-label study on what you considered the key active ingredient in your product and the study found efficacy of that ingredient. Is this enough to base advertising claims? Or, imagine you have a single ingredient product and there are already studies on that ingredient published in decent scientific journals and within the US — would this be considered substantiation?

In the case of the latter, the answer appears to be that the substantiation of prior third-party science is valid if the product you sell has the exact dosage and quality of the studies you are basing your claims on is adequate.

Weight-loss products
The Federal Trade Commission has announced its intention to be more active in policing the advertising of weight-loss products. In fact, the FTC?s publication A Reference Guide for Media on Bogus Weight Loss Claim Detection detailed the types of claims the agency believes to be almost impossible to substantiate. The FTC was granted this power in the Federal Trade Commission Act by the simple words within the act that note the prohibition of ?unfair or deceptive acts or practice.?

It is clear that deceptive claims are those that are misleading or false in some way because facts were misstated or omitted, or important information was not disclosed. Even if ?puffery? is used in an advertisement, it can be considered deceptive if substantiation for the basis of the claim is not real or valid.

There are many other areas that the FTC and FDA consider when evaluating if an advertisement is valid and these parameters should not be discarded. However, one should be cognizant of the FTC advertising and substantiation policy (known as the ?substantiation doctrine?) first enacted in 1972 and then further articulated in 1984.

Within the FTC?s actions, use of the ?Pfizer factors? in noting if a claim is substantiated is typically used. These include: type of product, type of claim, the benefits of a truthful claim, the cost/feasibility of developing substantiation, consequences of a false claim, and the amount of substantiation that experts in the field believe is reasonable.

Did you know that the FTC?s experts have stated that weight loss beyond one pound per week without dieting or exercise should be considered scientifically unfeasible?

The costs of noncompliance
While the FTC has not clearly defined what constitutes substantiation, it has provided a global overview of how the agency analyses marketing claims. In addition, the FDA along with the FTC point to a 1994 ruling on weight-loss claims that states that at least two well-designed randomised clinical trials are needed to support weight-loss and appetite-suppressant claims.

Companies that have run afoul of either the FTC or FDA have been pursued in courts and private actions, and have paid for it. Fines appear to have ranged from the cost of consumer redress to outright fines payable to the agency. In one recent case, the manufacturer and subsequent retailer of a popular weight-loss supplement paid $100,000 to the FTC and consented to not advertise any weight-loss supplements that did not have substantiation (not all parties in this suit have settled with the FTC).

In another FTC action, one company touting an oral growth hormone product paid the FTC $485,000 for consumer redress with a balloon clause of $5.9 million if the individual violates the consent order. Two other companies that also marketed these products have consented to pay the FTC up to $20 million for their unsubstantiated marketing claims.

In addition to the $20 million notation, the companies and officers named in the FTC action may have to pay up to an additional $80 million dollars if the FTC finds they misrepresented their finances. The consent order notes that substantiation is needed for claims and that the defendants have agreed to acquire the proper substantiation for future products they wish to retail.

With the possibility of losing $100 million dollars, will this company now finance studies to support their marketing? The FTC has been very active over the past few years and it appears they are more active than ever in enforcing substantiation laws.

In the big picture, since research and development is tax credible (IRS Code 174), why not spend the money now rather than paying fines and facing other consequences for being guilty of unsubstantiated marketing claims?

How to get started
Giving advice on how to prevent regulatory action is easy — do the research first before marketing a product. But this advice is not always followed. Contact the thought leaders in your market category, and let them know you have a product you want studied in a step-wise fashion (small open-label study, followed by a larger randomised placebo-controlled clinical trial). Coordinate your study through a private research firm or an academic centre that follows 21 CFR and utilises an Institutional Review Board.

Next, integrate with a law firm that understands how to cull intellectual property from research, so that you get your patents, trademarks and other information legally protected. Finally, make sure your study is presented and published at the appropriate conferences and in the right journals.

Taking these steps ultimately will lead to a better category view by regulatory agencies and improved consumer confidence.

Douglas S Kalman, MS, RD, is a director at Miami Research Associates, a clinical service organisation.
Respond: [email protected] All correspondence will be forwarded to the author.

Edward W Correia. The Federal Trade Commission?s Regulation of Weight Loss Advertising Claims. Food and Drug Law Journal 2004; 59(4)
15 USC 45(a)(1)(2000)
www.ftc/gov/bcp/guides/ad3subst.htm (104 FTC 648, 839 (1984))
Pfizer Inc. 81 FTC at 91-93.
118 FTC 1030, 1123, 1127 1994 Consent Order. FTC v. Schering

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